RNI nNo.6178/61

01

March 2021 Vol 60 No. 11

CONTENTS

Top Global Pharma Production & Packaging Machinery – 2020

News

Cell Line Vaccine Manufacturing

19

Sartorius’ Integrated technologies to accelerate process intensification

30

Pharma Production Machineries

Business News

Lab Equipments

Pharma Packaging

Tweets

Blog

Vaccine Manufacturing Facilities

Editorial Calendar

Advertising Rate Card For Magazine

Advertising Rate Card for Website

Ownership Statement

3

11

16

17

29

41

42

45

46

47

48

MARCH-2021

EDITORIAL PAGE

Invest in Vaccine ManufacturingVaccine Manufacturing is not a trendy production item. VBV for Humans is extremely important. India has 27 vaccine production units. We need more. Imprint is on a path to provide critical infor-mation on vaccine production process and machines. The first of such articles appears in this issue - Cell line Vaccine Manufacturing – Integrated technologies to accelerate process intensification for Viral vaccine manufacturing. Sartorius has provided in this article the process and equipment details. All other vaccine manufacturing equipment companies are welcome to contribute articles on their process and equipment.

This is a first initiation article on vaccine manufacturing process equipment. The CD-SCO list of 27 vaccine units is published in this issue [page 42] We have a Imprint Blog page in this issue. Vaccine Manufacturing technologists and or vaccine production en-gineers familiar with the process and equip-ment exist in India. If you are one, welcome to blog. Imprint believes that many more vaccine production units have to be estab-lished and the processing or production equipment must be deeply understood so and world class facilities come up. Cheers!

Top Global Pharma production and Packaging machinery -2020 –

[page xx] Imprint surveyed processing equip-ment and packaging launched by major

India has 27 vaccine production

units.

Associate PublisherAnuradha chopraEditorial Manager

Sakshi RanaAdvertising Manager

Gayatri PalWeb DeveloperPranesh Nande

ManagerPooja ModiAccountant

Sheetal JaiswalContent Production &

Response Office6C/4A Sangeeta

Apartment, Juhu Rd, Santacruz, Mumbai, W, Mumbai, Maharashtra

400049

RNI No.6178/61

Infocast Systems Private Limited (Im-

print Magazine) 6B/4A, Sangeeta Apartments, off, Juhu Rd, opp. SNDT

college, Revdandkar Mag , Santacruz West,

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brands globally in 2020. We list, in this article, critical steps in production units that are common to most production units. Imprint selected TOP machines in each category fulfilling criteria of innovation and safety, apart from speed and productivity. In this article out of 23 critical common manufacturing steps we have features SIX processing equipment categories. In future issues Im-print shall feature TOP launches in 2020 of the balance categories of critical common steps in manufacturing. Imprint reproduces noteworthy tweets of meaningful happenings in pharma industry and some revolutionary pharma production machine launches.Imprint is on a mission to promote pharma manufacturing, hence welcomes all pharma production machinery manu-facturers to use imprint’s Instagram platform as your platform to promote your latest launches or unique achievement or any story you wish to promote. Imprint will post your stories on its Instagram and ensure maximum reach to right audience.

MARCH-202102

Pharma Machineries

Vibro Sifter offered by Dumra MachinescGMP model with All contact parts AISI 316 & non contact parts AISI 304.

Vibro sifter consists of a screen laced on the base plate attached centrally to specially designed gyratory motor. The material fed through the inlet on the top is dropped on the screen. The particles smaller than the mesh size passes from the screen and the larger sized particles are released hrough an outlet. The combina-tion of vibratory motor and the weights placed on top and bottom of screen gives the desired filtration or separation of the material.

Total assembly is mounted on suit-able springs so that it becomes an independent body which vibrates without parting any vibrations to the base body.Optional Features:

• Double or triple deck sifting system.

Vibration can be adjusted by reset of vibration block. Vibro Sifter

Cadmach Machinery presents High Speed Tablet Press

#VibroSifterKeywords- Vibro Sifter, Dumra Machines

Provision For Vac-U-Max System For Powder Transfer

Cadpress V, a 5th GENERATION CAD-PRESS is a double sided high speed tableting press with a Pre- Compres-sion System & Dial-less operation.

Cadpress V

The machine is extremely reliable with maximum rated output of 540,000 tablets / hour.

Excel Plants & Equipments presents Multi Mill Machine

The offered machine can be used for high speed

granulating, mixing, shred-ding, pulverizing and chop-

ping.

MARCH-2021 03

Pharma Machineries

Steam Exchange Humidifier Condair SETC by Humidity TechnologiesBuilt in float and thermostatic steam trapsThe Condair SE steam-to-steam humidifier produces pure steam for humidification purposes from an existing bioler steam supply.

It is ideal for use in factories with a central steam boiler.

Condair SETC; Steam Exchange Humidifier

• Capacities upto 477 Kgs per hour.• Fully modulating control down to

25% capacity.• Insulated tank for efficient

operation.• Built in float and thermostatic

steam traps.• Suitable for use with RO , DI or

potable water

Keumsung Machinery offers HIGH SHEAR MIXER GRANULATORChopper lmpellar speed control at any rate it possible to have free forms of mesh• Mixing, kneading, granulating.• Cone type vessel.• Inside of vessel became perfect

cleaning is possible.• Open and close the exhaust

damper device.• Special sealing system for shaft.• Convenient automatic open &

close system for vessel cover.• Powerful driving by worm Gear.

• Agitator lmpellar is designed with the structure to maximize the buoyancy of raw material

• Chopper lmpellar speed control at any rate it possible to have free forms of mesh

• Lid open/close by air cylinder(2 step)

• Main Agitater lmpellar lifting type for CIP High Shear Mixer Granulator

Liquid Injectables Process Plants offered by Pharmatech ProcessEfficient Micro Filtration System of sterile application with pumping system.

Liquid Injectables Process Plants Range of Service

• Designing the sterile mix-ing vessels as per highest cGMP standards with Design Qualification.

• Providing qualification documents like DQ, FAT & Proto-cols of IQ & OQ.

• Providing custom required Au-tomation as per MCA & 21 CFR Part 11

• Providing custom required Au-tomation as per MCA & 21 CFR Part 11.

• Efficient Micro Filtration System of sterile application with pumping system.

• Providing required sterile accessories.

• Providing qualification docu-ments like DQ, FAT & Protocols of IQ & OQ.

Salient Features:• All contact parts SS 316L mirror

polished to less than 0.5 Micron + electrpolished

#LiquidInjectablesProcessPlantsKeywords: Liquid Injectables Process Plants, Pharmatech Process, sterile mixing vessels

• Zero Dead leg design for vessel and Flush bottom diaphragm value.

• Providing validated CIP & SIP devices without any shaded area in spray system

• Food grade Gasket conforming to FDA 21 CFR Part 177.2600

• Non-Contact parts SS 304 matt finished to less than 0.8 m Micron.

04 MARCH-2021

Pharma Machineries

Prism Pharma’s Slugging / Bolus Tablet PressThe PTCM-SH-12 Tablet press is offered in different two models GMP & Stan-dard Viz. Special ToolingApplication and Process:Bolus Tablet Press Machine is used for production of simple and precise tablets from powder in Pharmaceuti-cal and relevant Industries.

• The PTCM-SH-12 Tablet press is offered in different two models GMP & Standard Viz. Special Tooling

PTCM-SH-12; Bolus Tablet Press Machine

Salient Features:• Design is cGMP - Current Good

Manufacturing Practices compli-ance.

• All contact parts AISI 316 & non contact parts AISI 304.

• Simple & Convenient Operation, Changeover, Cleanliness, Opera-tor Protection & Ease to Mainte-nance.

• Specially designed for pharma-ceutical, veterinary, bolus, slugs, pellets, chemicals, plastic, ce-ramics, powder metals and other specialized industries.

PTCM-SH-12 is single sided rotary slugging press with square body and suitable for small batch size production of bolus for veterinary and slugging of powder. The PTCM-SH-12 model machine is designed to enable to maximum cleanliness in operation and accessibility, thus of-fering tremendous easy to operate, clean and maintenance.

Automatic Rotary Glass/ Pet Bottle washing Machine by Veena PharmaAutomatic bottle washing machine operates on the rotary principle with GE-NEVA mechanismAutomatic bottle washing machine has many functional features as per GMP standard to wash containers of glass, plastic or other material. Automatic bottle washing machine operates on the rotary principle with GENEVA mechanism and requires manually loading and unloading of bottle.

Operation:In automatic bottle washing machine the bottles are loaded on a rotating platform where bottl e holders i.e. nylon cups are specially designed to accommodate bottles with varying neck diameter and bottle diameter.

Technical Specifications:• Max. Dia Of The Bottle : 85 mm.• Output /Minute : 64 B.P.M.• No Of Pumps : 2 Nos / Centrifu-

gal ½ “ Size

Automatic Rotary Glass/ Pet Bottle washing

Reva Pharma offers Turbo Mixer MachineThe machine can carry out highly even mixing of powders of granules.

Turbo Mixer Machine

• Multi - Directional Motion Mixer is a novel material mixer exten-sively used in Pharmaceutical, Chemical, Metallurgical food, Light and Agricultural industries.

• This machine can carry out highly even mixing of powders of granules.

• So that the mixed material can reach their best effectiveness

• The Mixing Barrel is supported by the driving and driven shafts which are crossed in space and also vertical to each other. And are respectively connected by Y-type universal joint.

• So that the Mixing Barrel makes unique translational, turning, roking and rolling motions in a solid 3-dimensional space.

• Thereby speeds up the flow and diffusion of the materials being mixed. While avoid the specific gravity segregation of materials due to the action of centrifugal force in an ordinary mixer.

MARCH-2021 05

Pharma Machineries

Reva Pharma offers Turbo Mixer MachineThe Flashmix is based on an EHEDG and 3-A Certified hygienic mixerThe Silverson Flashmix takes a revolutionary approach to powder/ liquid mixing, the Flashmix liter-ally forces powder into the liquid stream. This not only allows it to disperse and hydrate large volumes of powders, it means it can be used at higher temperatures and with higher viscosity mixes - offering the advantages of high shear mixing to a wide range of applications that were previously not possible.

• Design is cGMP - Current Good Man-ufacturing Practices compliance.

• All contact parts AISI 316 & non con-tact parts AISI 304.

• Simple & Convenient Operation, Changeover, Cleanliness, Operator Protection & Ease to Maintenance.

• Specially designed for pharmaceuti-cal, veterinary, bolus, slugs, pellets, chemicals, plastic, ceramics, powder metals and other specialized industries.

Flashmix Advantages

Fast powder incorporation rates of up to 500 lbs/min

Formpak’s Automatic Capsule Filling Machine for Tamping, Dosating or Volumetric FillingOutput: Up to 90 000 capsules per hour for powder filling.Functional Description:The AF-90T is a high capacity fully automatic capsule filling machine that can fill a large variety of pow-der formulation into hard gelatine capsules. The machine is formulation friendly and it uses a tamping pro-cess to form a slug which is inserted into the empty capsule. Pellet filling device is available as an optional attachment.

Operating Sequences:• Capsules are orientated and

loaded into bushes and separat-ed.

• Cap and body segments sepa-rate.

• Optional station for pellet filling attachment.

• Station for powder filling by tamping.

• Idle• Unopened capsule ejection.• Capsule closing station.• Discharge of filled capsules.• Cleaning of cap and body bushes

by air and vacuum.

Cleaning of cap and body bushes by air and vacuum

AF-90T, Automatic Capsule Filling Machine

Low Temperature Pulverizer - Cloud Mill presented by Yenchen MachinerySimple operation yet detailed control through large LCD touch panel

Features:High yield, efficient system to ensure low waste of raw material High pulverization efficiency, i.e. high kg/kW ratio.A wide range of particle size support-ed and customizable by demand. Grinding size up to 500 mesh

Applications:Nuts, Spices, Mixed grain, Herbal medicine, Food, Chemical materials, Pharmaceuticals, Chemical materials, Fishmeal, Paper powder

High uniformity in particle size distribution Low Temperature

Pulverizer - Cloud Mill

06 MARCH-2021

Pharma Machineries

Sanity Co offers Aprila SG50 Softgel Encapsulation MachineMaximum operating speeds up to 3.5 RPM

Aprila SG50Features:• Maximum operating speeds up

to 3.5 RPM

• Simple to use control system Medicine injection pump Die rolls – 2 ” long x 6 ” diameter Teflon coated brass medicine injection wedge.

• Bronze construction spreader boxes

• Chilling / Casting drums• Lubrication system• Capsule discharge and conveying

system• Dual tumble dryer system

Auxiliary Equipment• 60 liter gel melting / mixing &

transfer tank• 20 capsule drying trays• Capsule drying dolly• Chilling system for cooling drums• Spare parts package

Teflon coated brass medicine injection wedge

Filter Testing Equipment presented by Filtereno EngineeringThe skids are manufactured using high grade components and advanced technolo-Product Details:Display Type- Analog,Digital; Grade- Semi-Automatic,Automatic Supply- DC

Owing to perfection and quality oriented approach, Filtereno have carved a niche in the industry by offering an enormous grade array of Filter Testing Equipment.

Extensively used for the measure-ment of surface friction properties, these skids are manufactured using high grade components and ad-vanced technology by our skilled pro-fessionals. To ensure quality, these testing skids are stringently tested on various parameters. Clients can avail the offered skids in different specifi-cations as per their needs. Filter Testing Equipment

Octagonal Blender by Sharp PharmaAll safety guards & covers made out of SS304 in GMP Model.

Octagonal Blender Description:OCTAGONALBLENDER: Capacity : 10 kg., 25 kgs., 50 kgs., 100 kgs., 200 kgs., 300 kgs., 500 kgs.

All moving parts covered with SS304 covers.

Operation:The OCTAGONAL Blender is an efficient and versatile machine for mixing dry powder and granules homogeneously. Two third of the vol-ume of the Cone Blender is filled to ensure proper mixing. It can be used for Pharmaceutical, Food, Chemical and Cosmetic products etc.

Salient Features:• The conical shape of both ends

enables uniform mixing and easy discharge.

• All contact parts are made out of SS 316 / 304 quality material.

• Maximum care has been taken to ensure safe operation of the unit.

• Manual rotating facility with hand wheel for itching. The same will be provided with ss cover & limit switch. ( In 200 Kgs. & above model )

• Two nos. of safety roads will be provided at the back side. ( One LH side & one RH side )

MARCH-2021 07

Pharma Machineries

Hitachi’s High Resolution Inspection SystemThe machine accurately detects the small movement in submerged particles; also perform cosmetic inspections to detect scratches, stains and shape de-In compliance with the wishes of the many voice of pharmaceutical com-panies, the HR series born in 2002, is an inspection machine for sterile formulation developed using image processing, conveyance, and control technology that Hitachi has cultivat-ed for the last 30 years.

HR Series; High Resolution Inspection Machine

It can accurately detect the small movement in submerged particles as well as perform cosmetic inspections to detect scratches, stains and shape defects. Meeting the demands of strict quality standards of pharma-ceutical companies, our inspection machine will protect the safety of all patients in need.

Jicon presents Starch Paste KettleJacket provided with thermic heating – uses electricity, eliminates the need for steamStarch Paste Kettle is used for prepa-ration of binder materials,used in medicine and food industries. This machine has an electrically heated jacket, thus eliminating the need of providing a steam connection for heating. It also eliminates the need to tilt the vessel to empty its con-tents

vessel which can be emptied directly into containers which can be kept beneath it. This makes the handling of the hot starch paste much safer for the operators.

Features:• All contact part made of SS 316

as per GMP standard• Hemispherical design for proper

mixing of paste

Starch Paste Kettle

Anchor type impeller design for proper mixing of paste

Tablet De-Duster Machine offered by Pharma PackagesInfinitely variable vibration speed for optimal tablet cleaning and deburring.

PP4; Tablet De-Duster MachinePP4, the most effective deduster equipped with an unique clearingsystem that effectively removes all loose dust and static powder, ad-hered to the tablets.

PP4 is ideal for batch cleaning, dusting or direct hook up to even the fastest tableting machines.

High output capacity upto 4,50,000 tablets/hr.

The PP4 cleans, deducts and deburrs tablets by means of vibration and vacuum as the tablets travel through a 3.2 meters long spiral perforated path. The tablets are then ready to make a perfect coating finish or for immediate packaging in containers, strips or blisters.

Technical Data:• Output : Upto 4,00,000 tablets/

hr• Tablet Travel Distance : 3.2 me-

ters.• Travel Time : 16 to 40 secs de-

pending on speed and vibration.• Suction Requirement : 100-150

cfm at approx. 3” column of water.

• Power Supply : 220 volts, Single Phase, 50 cycles/sec 2 Amps.

MARCH-202108

Pharma Machineries

Gelatin Equipments from SaffroysPLC Controlled melter-mixer including Load cell

• Melter mixer, gelatin tanks, color mixers, holding tanks, etc are all manufactured to international standards

• For better performance and control these are computer con-trolled using specially developed Safrroys software

• Fully Automatic, double jacketed and insulated Melter Mixers

• PLC Controlled melter-mixer including Load cell

• Hydraulic top cover lifting and Stainless Steel agitator

• All contact parts made of AISI 316L and non contact parts made of AISI 304.

Fully Automatic, double jacketed and insulated Melter Mixers

• Raw materials are taken in au-tomatically, process started and stops only after complete prepa-ration of solution required.

Gelatin Equipments

Yenchen’s Pelletizer MachineA pellet machine is used to compress a variety of resources into a tiny pellet. Yenchen provides a qualified machinery here, offering a practical way to produce them. The equip-ment is designed for various types of pharmaceutical and food production.

Pelletizer Machine

Yenchen pellet machine has a rotatable matrix disc, vertically adjustable pressing rollers that can control the position of the upper and lower plungers, a drive for a height adjustment of the rollers, a housing accommodating the drive, and a bearing block supporting the pressing roller.

High Speed Tablet Press offered by CadmachThe machine is offered in four different turret configurations (45,55,69 & 75 stations) with maximum rated outputt of 540,000 tablets / hour.

Cadpress V, a 5th GENERATION CADPRESS is a double sided high speed tablet-ing press with a Pre- Compression System & Dial-less operation. It is one of the most advanced machine in its class with improved sound reduction ,operator safety, cleanliness & cleanability and operation convenience.

Provision For Vac-U-Max System For Powder Transfer

The machine is extremely reliable and is offered in four different turret configurations (45,55,69 & 75 sta-tions) with maximum rated output of 540,000 tablets / hour.

• Bi-layer Attachment• Lower Punch Spray Lubrication

System• Gravity Feeding System• Very Low Powder Level Sensing

Device• Hopper With Agitator Assembly

& ACVFD Cadpress V; High Speed Tablet Press

MARCH-2021 09

Pharma Machineries

Singhania Tableting Presents Tablet PressControl knobs fitted with Seiko dials for fine control.

Mega Press

Higher output and minimum mainte-nance, this mega press

design is guided by our philosophy of providing simple and efficient tableting solutions.

Separate control panel, not attached to the press

The mega press has center drive,with no gear on the turret. The machine is designed for 10 tons pre-compres-sion pressure. All eight compression rollers are identical and interchange-able.

The rollers do not require continu-ous lubrication. Front control for all external control mechanisms. Multi chamber food grade gravity feeder.

Upper punches completely covered to avoid powder settlement. Com-mon hopper for rotary and gravity feeder. Bottom driven rotary feeder. Control knobs fitted with Seiko dials for fine control. Separate control panel, not attached to the press.

Natoli Engineering Presents Research Tablet PressThe multi-functional NP-RD30 comes equipped with features that take you all the way from R&D through production.The multi-functional NP-RD30 comes equipped with features that can take you all the way from R&D through production. Outperforming any other tablet press in its class, the NP-RD30 replicates the design and functional-ity of a full-scale

Push-button, Self-adjusting Lower Punch Retainers

production press with the analyti-cal capabilities of an R&D machine. Whether you’re manufacturing small clinical batches or working with a new product, the NP-RD30 rotary press is built for ultimate efficiency and the dependability you need to reach your goals.

NP-RD30, Research and Development tablet press HEAVY DUTY

Tooling offered from Pacific ToolsPacific manufactures tooling in both TSM & EURO standards.

Standard Tooling- Standard Tooling is basically round and shaped tooling manufactured as per exact standards to suit any tablet press Worldwide. Pacific manufactures tooling in both TSM & EURO standards.

Standard Tooling

Standard Tooling is basically round and shaped tooling manufactured as per exact standards to suit any tablet press Worldwide. Pacific manufac-tures tooling in both TSM & EURO standards.

MARCH-202110

Business News

Commitment to partner with the Government of India to make the vaccine available in the country: PfizerUK regulator, MHRA, has issued a temporary authorization for the emergency use of the COVID-19 mRNA vaccine.Global pharma major Pfizer, on Thursday, said that it remains com-mitted to engaging with the Indian government to explore opportunities to make Pfizer/BioNTech vaccine available in the country. On Wednes-day, the UK became the first country to approve Pfizer/BioNTech against COVID-19.

Pfizer is committed to ensur-ing everyone has the

opportunity to have access to the vaccine, and is working closely with

governments

“During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective govern-ment authorities and following regu-latory authorisation or approval,” the statement said.

Relay and Genentech into a license for $75 million for Relay cancer MedRLY-1971 has the potential to serve as a backbone for combination therapy across numerous solid tumors, represents an encouraging approach for cancer patientRelay Therapeutics, a clinical-stage precision medicine company, an-nounced it has entered into a worldwide license and collabora-tion agreement with Genentech, a member of the Roche Group, for the development and commercialization of RLY-1971, a potent inhibitor of SHP2. Under the collaboration,

Genentech will assume development of RLY-1971 with the potential to expand into multiple combination studies including with Genentech’s investigational inhibitor of KRAS G12C, GDC-6036. ”RLY-1971 has the potential to serve as a backbone for combination therapy across numer-ous solid tumors for cancer.

Genentech has a longstand-ing commitment to under-

standing the underlying biology of KRAS

Nordic Capital and Astorg invest in pharmaceutical technology and advanced analytics company CytelCytel’s mission is to continue providing life sciences companies with cut-ting-edge clinical trial optimization technologies and harness the full value of their clinical and real-world data.Nordic Capital and Astorg today announced an agreement to jointly acquire Cytel Inc. (“Cytel”), from New Mountain Capital. Cytel is one of the largest providers of statistical software and advanced analytics for clinical trial design and biometrics execution.

Cytel is an industry pioneer of adaptive clinical trials, innovative quantitative methods for biotech &

pharmaceutical companies

Cytel is recognized as an industry pioneer of adaptive clinical trials and other innovative quantitative methods, helping biotech and phar-maceutical companies to reduce risk, increase R&D productivity and support medical innovation, improv-ing speed, productivity and efficiency of clinical trials

MARCH-2021 11

Business News

Bharat Biotech plans to install four Covaxin manufacturing plantsAround 200 million doses (per annum) will be produced in Hyderabad, 500 million doses in other citiesThe company is planning to produce 700 million doses per year. Around 200 million doses (per annum) will be produced in Hyderabad, 500 million doses in other cities. Bharat Biotech, which has been accorded Emergency Use Authorisation from the drug regulator for its COVID-19 vaccine Covaxin, on

Monday said they are setting up four vaccine manufacturing facilities with a combined capacity of 700 million doses Per annum.

Denying allegations that the city-based vaccine maker lacks data of Covaxin, Krishna Ella, chairman of Bharat Biotech, said

sufficient data has already been re-vealed and is available on the net.

The company plans to produce 700 million

doses per year

FDA Warning Letter to Clientele, Inc: No Adequate Quali-ty Unit, Laboratory Controls, Sampling Plans, and Stability ProgramThe firm produces OTC topical drug products that include sunscreen active in-gredients and pain-relieving active ingredients

The U.S. Food and Drug Adminis-tration (FDA) sent a Warning Letter dated 3 December 2020 to Clientele, Inc. The firm produces OTC topical drug products that include sunscreen active ingredients and pain-relieving active ingredients. During an in-spection from 3 to 7 February 2020, significant violations of current good manufacturing practice (CGMP).

No Adequate QU Oversight Ac-cording to the FDA, the company’s Quality Unit (QU) did not provide adequate oversight for the manufac-ture of the OTC drug products. For example, no microbiological testing was performed and reviewed for each batch before release, and sup-pliers were not adequately qualified.

No Adequate Stability Data Available During

the inspection

CPhI & P-MEC India rescheduled to 24 - 26 November 2021Informa believes next edition will allow more time for normality and confidence to return to the marketplaceOver recent weeks and months, we have been in constant discussions with key industry stakeholders, partners and the local government to stay abreast of the challenges and complexities in the face of disruption due to COVID-19. The 2021 edition will take place from 24-26 November 2021 at the same venue,

In this context, Informa Markets in India has taken the difficult but nec-essary decision to cancel the upcom-ing late edition of the CPhI & P-MEC India Expo 2020, scheduled for Jan-uary 27-29, 2021 at the India Expo Centre, Greater Noida, Delhi-NCR. They thank all the participants and those who have supported CPhI & P-MEC India Expo 2020.

Informa has developed a detailed set of enhanced

measures to provide highest levels of hygiene and safety at its events

MARCH-202112

Business News

Covishield to dominate overall COVID-19 vaccination drive in India: GlobalDataAs Per GlobalData, Serum Institute of India’s (SII) Covishield and Bharat Biotech’s Covaxin have recently re-ceived emergency use authorisation (EUA) in India. However, despite in-digenous vaccine Covaxin’s approval, Covishield will continue to dominate the overall vaccination drive in India According to GlobalData’s Pharma Intelligence Center,

Dr Reddy’s Laboratories is conduct-ing Phase II/III trial of Sputnik V and Zydus Cadila received approval to initiate Phase III trial of ZyCov-D in India. ZyCov-D is the second indige-nous vaccine to reach Phase III trials. Moreover, Pfizer has already filed for EUA in India and is still under review b y the Drugs Controller General of India (DCGI).

SII and Bharat Biotech have manufactured 60 million and 20 million

doses of COVID-19 vac-cines

Bharat Biotech to compensate if Covaxin causes side effectsCovaxin has demonstrated the ability to produce antidotes against Covid-19 in Phase 1 and 2 Clinical TrialsBharat Biotech has said the company will pay compensation to recipients in case of any serious adverse effects experienced after receiving the antidote.

The clinical efficacy of the vaccine is still be-ing studied in phase 3

clinical trials

In the consent form to be signed by the vaccine recipients, Bharat Biotech said, “In case of any adverse events or serious adverse events, you will be provided medically recognised standard of care in the government designated and autho-rised centres/hospitals. “ “The com-pensation for serious adverse event will be paid by sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine,” the consent form said.

In phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antidotes against Covid-19.

However the clinical efficacy of the vaccine is yet to be established and it is still being studied in phase 3 clini-cal trials, the vaccine maker said.

“Hence it is important to appreciate that receiving the vaccine does not mean

Aurobindo, Kinvan, K’taka Antibiotics qualified for PLI scheme to promote domestic manufacturing of drugsAurobindo Pharma has committed an investment of Rs 3,039 crore to set up production facilities for three eligible products

Hyderabad based Aurobindo Phar-ma, Kinvan Pvt Ltd, Mumbai and public sector firm Karnataka An-tibiotics and Pharmaceuticals are the three companies announced by the central government that have qualified for financial support under the production linked incentive (PLI) scheme for promotion of

domestic manufacturing of critical key starting materials (KSMs), drug intermediates and active pharma-ceutical ingredients (APIs).

Kinvan to invest Rs 447.17 Cr to build 300 MT capacity plant to

produce Clavulanic Acid

While Aurobindo Pharma has com-mitted an investment of Rs 3,039 crore to set up production facilities for three eligible products, Kinvan will invest Rs 447.17 crore to build 300 MT capacity plant to produce Clavulanic Acid. Karnataka Antibiot-ics will set up 1,000 MT production capacity to produce 7-ACA (a chemi-cal needed to produce cephalosporin antibiotics and intermediates) with an investment of Rs 275 crore.

MARCH-2021 13

Business News

Zydus Cadila’s Saroglitazar Mg receives orphan drug designation from USFDAODD provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon USFDA approval.Zydus Cadila on Thursday said the US health regulator has granted orphan drug designation (ODD) to its Saroglitazar Mg used for the treat-ment of patients with Primary Biliary Cholangitis (PBC), a liver disease. The United States Food and Drug Admin-istration (USFDA) has granted ODD to Saroglitazar Mg, Cadila Healthcare said in a regulatory filing.

Shares of Cadila Health-care were trading 0.06 per cent higher at Rs

462.50 apiece on BSE.

Zydus Cadila, a part of Cadila Group, said orphan drug designation pro-vides eligibility for certain develop-ment incentives, including tax credits for qualified clinical testing, pre-scription drug user fee exemptions and seven-year marketing exclusivity upon USFDA approval.

Mexico to import 870,000 AstraZeneca vaccine from India: President Andres Manuel Lopez ObradorMexico also has a deal with AstraZeneca to produce its vaccine for distribu-tion in Latin America, with financial support from the foundation of Mexican billionaire Carlos SlimPresident Andres Manuel Lopez Obrador said, Mexico plans to import about 870,000 doses of AstraZene-ca’s COVID-19 vaccine from India in February, also producing it locally. Mexico and Argentina have a deal with AstraZeneca to produce its vaccine for distribution in Latin America, with financial support from the foundation of Mexican billionaire Carlos Slim.

“We are also getting AstraZeneca vaccines, apart from the agreement we have with them – these vaccines are being made here in Mexico – we will bring AstraZeneca from India,” Lopez Obrador said in a video broad-cast on social media. Meanwhile, deliveries of Pfizer’s COVID-19 vac-cine to Mexico would “very proba-bly” resume on February 10, Lopez Obrador

said, after global delivery delays by the US company. Mexico was ex-pecting about 1.5 million doses from Pfizer, he noted.

Lopez Obrador, speaking publicly for the first time since revealing he had COVID-19, said Mexico would also receive 870,000 doses of Russia’s Sputnik V vaccine in February.

1.1 Billion Doses Of COVID-19 Vaccines To be supplied to UNICEF by IndiaIndia plans to gift vaccines doses to Oman, CARICOM countries, Nicaragua, Pacific Island states: Anurag Srivastava EAM SpokespersonIndia’s Serum Institute will be supply-ing 1.1 billion doses of coronavirus vaccines developed by AstraZeneca and Novavax to around 100 countries for approximately USD 3 per dose for the low and lower- middle-income countries, said Henrietta Fore, Unit-ed Nations International Children’s Emergency Fund (UNICEF) chief, on Wednesday.

Covaxin, Covishield re-ceived EAU after going

through established safety and immuno-

genicity in a well-pre-scribed regulatory

process

She further added, Today, we are pleased to announce the conclusion of a long-term supply agreement with the Serum Institute of India for the COVID-19 vaccines, to access two vaccine products through technol-ogy transfer from AstraZeneca and Novavax, Sputnik quoted Fore as saying at a COVAX press briefing.

MARCH-202114

Business News

Aurobindo Pharma Q3 results reports an over four-fold jump in its consolidated net profit to ₹2,946.32 croreThe consolidated revenue from operations of the company stood at Rs 6,364.91 crore. It was Rs 5,895 crore for the same period a year agoAurobindo Pharma reported an over four-fold jump in its consolidated net profit to ₹2,946.32 crore for the quarter ended December 31, 2020 mainly on account of one time ex-ceptional gains.Aurobindo Pharma, Managing Director N Govindarajan said, we maintained growth momentum in our revenue and profitability despite COVID challenges.

We maintained growth momentum in our

revenue and profit-ability despite COVID

challenges.

The company had posted a net profit of ₹705.31 crore for the correspond-ing period of the previous fiscal, Aurobindo said in a BSE filing.

The consolidated revenue from operations of the company stood at Rs 6,364.91 crore. It was Rs 5,895 crore for the same period a year ago, it added.

India’s demand for Covid-19 drug remdesivir likely to fall: CiplaIndia’s average daily coronavirus caseload was about 53,000 in October and November, and plunged to around 27,000 in December. Daily cases had hit a peak in September.

India’s demand for Covid-19 drug remdesivir will likely fall in coming months, as daily coronavirus in-fections in the country continue to decline, said Drugmaker Cipla on Tuesday.

In India, Cipla was among the first companies to launch a generic version of remdesivir, developed by US-based Gilead Sciences.

Kedar Upadhye, Cipla’s global chief financial officer said, “There is a direct link between the number of cases and remdesivir sales,” He did not provide details on how much he expected demand to fall. Upadhye also added, Demand for the drug was still robust in October and No-vember, but began to drop in Decem-ber. India’s average daily coronavirus Kedar Upadhye, Cipla’s Global

Chief Financial Officer.

Daily cases had hit a peak in September.

Bharat Biotech seeks approval in over 40 countries for CovaxinIndia approved Covaxin along with Serum Institute manufactured Covishield for emergency use earlier this year.As per reports, Bharat Biotech’s the indigineous developer of coronavi-rus vaccine is in the process of filing regulatory documents for approval of its vaccine, Covaxin, in more than 40 countries. The Hyderabad-based biotech on Wednesday said that the process for filing the documents is underway.

Covaxin is currently being used in India’s

vaccination campaign, already covered over 9 million health workers

“We have submitted our documen-tation in Brazil and other countries and await their approval. We plan to export several million doses to Bra-zil,” the company said in an emailed statement. ”Pricing of Covaxin for international markets will be based upon supply timelines, purchase commitments and procurement volumes.”

MARCH-2021 15

Lab Equipments

IKA Temperature ControlICC basic also has an optional cooling coil that allows to work close to ambient temperatures.Compact immersion circulator ICC basic for tempering of liquids up to 150 °C. Suitable to use in open or covered bath vessels. The integrated pressure/ suction pump allows ICC basic to be used for internal and ex-ternal applications. Just connect the optional pump set. ICC basic also has an optional cooling coil that allows to work close to ambient temperatures.

Visual and acoustic safety warnings

• Temperature range: RT - 150 °C• Temperature stability: ± 0.02 K• Powerful, speed-controlled pres-

sure/suction pump• Holding clamp for attaching the

circulator to a bath is included

• Convenient carrying handle und integrated brackets

• Large easy to read LED dis-play for pump speed and temperature

UV Vis Cuvette Spectrophotometer from Mettler ToledoCompact layout of optical components allows for strikingly small footprint. Instrument can be operated as a standalone without the use of a PC.

Spectrophotometer UV5 UV/Vis Spec-troscopy – Fast and Compact.

Instant spectrophotometry with no warm-up and full-spectrum scan-ning in a second. Save bench space. Xenon flash lamp and no moving parts ensure robustness. Intuitive interface and guided workflow for quality control, water testing and color measurement.

Xenon flash lamp and no moving parts ensure

robustness.

Simple One Click™ OperationThe large color touchscreen features an intuitive One Click™ interface. All users have their own home screen, enabling daily tasks in just One Click.

Ready to useThe instrument is shipped ready for immediate use. Simply power it up and start measuring.

Rotary Evaporator from IKAFlask clamping mechanism with integrated push-off function for easy exchange of evaporation flasksThe new RV 3 Rotary Evaporator is the ideal entry-level model of the IKA rotary evaporator portfolio. It finds a multitude of uses in the chemical, pharmaceutical, and biotechnology industries, in research and develop-ment, in manufacturing and quality assurance, in laboratories, and in plant construction. Thanks to special-ly designed glass guides, the con-denser makes extremely efficient use of the 1500 cm² cooling surface.

• New: 4 l heating bath for up to 99°C

• water heating bath with digital temperature display and carrying handles

• mechanical lift end-point safety stop

• locking mechanism: red indicator shows unlocked position of the vapor tube

high-efficiency condens-er with 1500 cm² cooling

surface - low space re-quirements

Rotary Evaporator; RV 3 V

MARCH-202116

Pharma Packaging

High-Speed Horizontal Form Fill-Seal Machine presented by Omori Machinery15.5 inch wide touch panel (capacitive type) is adopted to improve expressiveness by graphic display

Product features• We have adopted an opera-

tor-friendly revolver-type film supply with the film set in a low position.

• By making the supply conveyor a frameless structure, toolless attachment / detachment and cleanability of the finger chain have been improved.

NSW-7000

Simplification of data creation by automatic

shift calculation

• By adopting a modular design, it can be easily attached / de-tached / maintained in units. In addition, the upper plate and lower belt can be opened and closed without tools, making cleaning easy.

• Operability has been improved by screen renewal.

N.K.P Pharma presents Self Adhesive Vertical Vial LabellerASAL-120 has a production rate of attending up to 120 vials/min, ASAL-250 is 240 vials/min.Automatic Self Adhesive vertical labelling machine is another one of the high technologically proficient machines offered by NKP Pharma and it comes it two variants- ASAL-120/250.

The labeler can apply label for all the lengths

starting from 12mm.

ASAL-120 has a production rate of at-tending up to 120 vials/min. On the other hand, for ASAL-250, it shoots up to 240 vials/min. Both these vari-ants of self adhesive vertical labelling machine require 2 HP of electric supply in order to ensure that the operations performed by them are an efficient one. The vial labeler ma-chine is capable of applying label for all the lengths starting from 12mm.

ASAL 120/250, Automatic Self Adhesive Vial Labelling Machine

Multipack presents Self Adhesive Sticker Labelling MachineThe built-in Advanced Micro Processor Control Label Dispensing system and operator friendly sensing system are very much useful for labelling and product packaging.Multipack machinery provides auto-matic vertical linear sticker labeling machine model MULTIPACK-60F which is very user friendly used for applying label on front, back or side for oval/flat/square/round/ shape containers with labelling speed of up to 100 labels per minute. It is synchronized with top holding belt system.

No Label Data Input/retrievals require for any

Label SizeLabelling Machine Built-In Unique Features:• No Label Data Input/retrievals

require for any Label Size.• Virtually Maintenance free ma-

chine

MULTIPACK-60F, Self Adhesive Sticker

MARCH-2021 17

Pharma Packaging

Blister machine B 200 from UhlmannConsistent forming and sealing times for maximum process reliability and OEE regardless of the number of cycles

Blister machine B 200

Optional output upgrade to 300 blisters per minute

Max. 200 or 300 blisters/min. Max. format area 200 × 1454 mmFlexible blister machine for small batches and/or special blister formats

Top quality at an attractive entry-lev-el price and excellent flexibility form the basis for the economically efficient packaging of small batches in particular.

Highlights:• High-cost effectiveness due to

short cleaning and changeover times.

• Consistent forming and sealing times for maximum process reli-ability and OEE regardless of the number of cycles.

• Optional output upgrade to 300 blisters per minute

Flat Sealing Machines From Elmach MachinesFlat forming, flat sealing machine for thermo-formed and cold-formed BlistersSalient Features:• Motion controlled independent

servo driven stations• Capable of running all types of

forming materials• Quick and easy changeovers• Output up to 450 blisters/min• Motion controlled independent

servo driven stations

EPI-3015 PDA, Blister Packing Machine

FEATURES:• Alu/alu forming capability with

forming depth correction on the fly

• Continuous monitoring of sealing pressure for consistent blister quality

• Designed to run PVC, PVC/PVdC, PVC/ACLAR, PET and PETG com-bination films.

The machine can Switch from thermo-forming mode to cold-forming

mode by selection on the HMI

• All work stations, servo motor driven

• Switch from thermo-forming mode to cold-forming modeby selection on the HMI

• Optional isolation of product fillarea available

• Touch screen for operator inter-face

• Robust 4-column station design for durability and reliability

Rotary Bottle Washing Machine presented by The United EngineeringHigher capacity centrifugal pump to wash bigger bottles

The offered machine is manufac-tured using high quality components and modern techniques under the guidance of our diligent profession-als keeping in mind latest quality standards. The provided machine is widely used to wash cyclic bottles in cosmetic, chemical and pharmaceu-tical industry. This machine is also checked on various quality param-eters before dispatching it to the clients’ end.

Less power consumption and long service life

Features:• Higher capacity centrifugal pump

to wash bigger bottles• Separate panel control for avoid-

ing any short circuit • Less power consumption and

long service life• The stationary nozzle avoid chip-

ping of bottle necksHigh Pro-ARBW

MARCH-202118

Vaccine Manufacturing is not a trendy production item, speedy

vaccine development is a KEY factor where large quantity of vaccines

are NEEDED for trials, Imprint covers the Human embryonic kid-

ney-HEK 293 Cell line delivering a upstream cell and media selection,

high throughput perfusion system, intensified seed train and scale

up, downstream purification of virus for VBV production, purification

and formulation, and finally virus analytics from Sartorius, Germany.

This is a first initiation article on vaccine manufacturing process equip-

ment. India does have 21 vaccine manufacturing companies (click here)

listed by CDSCO. Vaccine Manufacturing technologists and or vaccine pro-

duction engineers familiar with the process and equipment exist in India.

However, Imprint believes that many more vaccine production units have

to be established and the processing or production equipment must be

deeply understood so efficient and world class facilities come up. Cheers!

Cell Line Vaccine

Sartorius’ Integrated technologies to accelerate process intensification

Integrated Technologies to Accelerate Process Intensification for Viral Vaccine Manufacturing

Process Intensification of VBVs

An advantage of using cell culture to produce VBVs is that they could potentially be manufactured using process intensification. This is an

approach to process development originally pioneered in the chemical industry by the Process Technology Group at Imperial Chemical

Industries (ICI) in the UK. The aim was to reduce plant size while increasing productivity, thus decreasing the cost of goods (CoGs) by lessening

capital investment and overhead costs (Nestola et al 2015). Today, multiple definitions of process intensification have been developed but all have the

ultimate goal of increasing productivity. Process intensification could be used for SARS-CoV-2 vaccine manufacturing, to utilize facilities with a smaller

plant footprint and less scale up volumes to rapidly produce large number of doses required for mass vaccination campaigns. This is because there

are more 2000 L scale bioreactors than 20,000 L good manufacturing practice (GMP) compliant bioreactors which can be accessed quickly. Therefore,

utilizing an intensified cell culture process could improve overall manufacturing yield to produce 10-20 doses of vaccine/mL, making it possible to

perform 2000 L runs and produce sufficient vaccine for small scale trials. For example, by increasing the final titer of VBVs by 1 log a potential scale up

could be reduced from 20,000 L to 2000 L, which would have a significant effect on overall production timelines. Using process intensification, allows

a reduction in bioreactor size, and therefore the use of SU bioreactor for commercial production. VBV manufacturers could also improve their supply

chain by becoming more flexible with ballroom style facilities and moveable skids, which allow rapid product changeover. Furthermore, using process

intensification offers the possibility of remaining in the same facility throughout clinical development and potentially the initial years of commercial

launch. VBVs and other types of vaccine generally require long phase 3 trials where manufacturers have to produce a large number of doses for trials

without knowing if their vaccine is going to be effective enough to become commercialized (Weinberg et al 2012). For phase 3 trials, manufacturers

have to scale up production or move to a new facility to produce the 10,000 to 30,000 doses normally required.

Manufacturing

Vaccine Production

21 March -2021

Process intensification could be used for SARS-CoV-2 vaccine manufacturing, to utilize facilities with a smaller plant footprint and less scale up volumes to rapidly produce large number of doses required for mass vaccination campaigns. This is because there are more 2000 L scale bioreactors than 20,000 L good manufacturing practice (GMP) compliant bioreactors which can be accessed quickly. There-fore, utilizing an intensified cell culture process could improve overall manufacturing yield to produce 10-20 doses of vaccine/mL, making it possible to perform 2000 L runs and produce sufficient vaccine for small scale trials. For example, by increasing the final titer of VBVs by 1 log a potential scale up could be reduced from 20,000 L to 2000 L, which would have a significant effect on overall produc-tion timelines.

Using process intensification, allows a reduction in bioreactor size, and therefore the use of SU bioreactor for commercial production. VBV manufacturers could also improve their supply chain by becoming more flexible with ballroom style facilities and moveable skids, which allow rapid product changeover. Furthermore, using process intensification offers the possibility of remaining in the same facility throughout clinical development and potentially the initial years of commercial launch.

VBVs and other types of vaccine generally require long phase 3 trials where manufacturers have to produce a large number of doses for trials without knowing if their vaccine is going to be effective enough to become commercialized (Weinberg et al 2012). For phase 3 trials, manufacturers have to scale up production or move to a new facility to produce the 10,000 to 30,000 doses normally required. This is unlike a phase 3 trial for a monoclonal antibody (mAb) therapy, where patient popu-lations are smaller and is a major difference between mAb and vaccine clinical studies and manufac-turing.Using intensified processing means that a pilot facility could provide all the material for this clinical phase, which mitigates the risk of having to build a new facility, that would not be used if the VBV fails in Phase 3. The SARS-CoV-2 pandemic is also an exceptional situation, in which some clinical trials might be combined or accelerated, creating the need to have thousands or even millions of doses available in a very condensed timeline. Process intensification also offers the opportunity for more localized production of VBVs in low to middle income (LMI) counties because it can provide more doses/mL, potentially making the cost per dose lower. This will help the transfer towards LMI countries, where having a fully closed, high titer process is essential to minimize GMP requirements, prevent unwanted contamination, and avoid the need for scale up. In this case, a scale out would be feasible and more easily manageable than a scale up especially in a setting where bioprocessing skills and knowledge may be lacking. Process intensification for VBV production is built on three pillars, equipment, mode of operation and technology (Figure 1) and many manufacturers are assessing and adopting these pillars around process intensification generally in a step-wise approach.

Fig: 1 The three pillars of process intensification with VBVs

MARCH-2021 19

Vaccine Production

One stratergy to determine the optimum cell line , sub-clone and media combination for VBV intesified cell

culture is to screen diffrent media , feed and sub-clone.

Process Optimization

Process optimization and process understanding are key to ensuring a straightforward scale-up or transfer the process. Similar to clone and media selection, process optimization often uses glass benchtop bioreactors as models and requires a considerable amount of time for set-up, as well as labor intensive pre- and post-process cleaning and sterilization with every experimental run. However, automated single-use mini bioreactor systems such as the Ambr® 250 technology (Sartorius), can be used as models (250 mL working volume) for developing intensified fed batch and now perfusion cell culture (Figure 3) for VBV process development. The system is able to operate with suspension culture, as well as adherent culture using microcarriers, and studies have shown that these bioreactors can allow cell densities (between 1.8 and 3.5 × 106 cells/mL) with a high cell viability (> 90.5%) of BHK21 suspension cells for VBV production (Garcia et al 2019) and 1.5-5 × 106 cells/mL (95% viability) from an initial inoculum of 8.5 × 104 cells/mL with adherent Vero cells cultured on microcarriers (Cytodex 1, 4 g/L) for 13 days (Zoro et al 2017).

These studies indicate that mini bioreactors could enable process optimization studies for developing a SARS-CoV-2 vaccine with suspension or adherent cell lines because BHK21 cells have been used to produce a coronavirus vaccine candidate for Middle East respiratory syndrome (MERS) (Li et al. 2020) and the SARS-CoV-2 virus can replicates to high titer in Vero cells (Harcourt J. et al 2020). Since the Ambr® 250 bioreactors have similar geometries to larger stirred tank vessels such as Biostat® STR bioreactors, this could help develop process intensification conditions with the potential to improve the productivity of inactivate or live attenuated vaccine and produce multiple doses/mL of a SARS-CoV-2 vaccine which can be seamlessly transferred to pilot and manufacturing scale. Another application is the optimization of HEK293 which are a common

platform the production of VBVs using adenovirus (Fedosyuk et al 2019)

process optimization often uses glass benchtop bioreactors as models and requires a considerable

amount of time for set-up

March -202123

MARCH-202120

Vaccine Production

March -2021 24

Intensified Seed Train and Scale-up

Intensified processes have been established for mAb based therapies (Zijlstra, 2014), which can be adapted as a low-risk approach for production of a SARS-CoV-2 vaccine candidate and an intensified seed train, which could be used is shown in Figure 3.

For VBV seed train process intensification and cell bank manufacturing services, which can produce high cell density vials to seed rocking motion (RM) bioreactors can be used. For example, Sartorius has cell banking equipment that uses an automatic closed single-use vial filling system, Fill-It which can fill 500 vials with up to 5mL at 50 × 106 viable cells/mL. These vials can then seed scalable RM bioreactors. For simple operation, these bioreactors should include an integrated perfusion membrane so that no external cell retention device is needed, for instance,

Biostat® RM :- a fully GMP compliant, rocking motion bioreactor that comes with a range of single-use bioreactor bag sizes from 2 L up to 200 L, and a maximum 100 L volume. For process intensification at manufacturing scale, singleuse stirred tank bioreactors which are capable of high cell density culture are required. Sartorius’ Biostat® STR which scales from 12.5 L to 2000 L is being used at CanSinoBIO Biologics and the Institute of Bioengineering to manufacture China’s first SARS-CoV- 2 vaccine candidate (Ad5-nCoV) using an adenovirus-based viral vector platform. With process optimization, this bioreactor range could potentially be used for process intensification of this application in the future. Finally, for successful process intensification, RM and STR bioreactors need to include process control with PAT (Process Analytical Technology) tools to control and monitor conditions between batches Technologies such as BioPAT® ViaMass for on-line cell counts which monitors and controls (exponentially growing) perfusion culture and allows automatic feeding and bleeding (Carvell et al 2016) can monitor on-line conditions for cell growth and infection in Biostat STR® bioreactors for example MVDA (Multivariate Data Analysis) software can analyze the data from these sensors more easily for feedback control and modeling, which is essential for ensuring that all the parameters are tightly controlled during the virus production step.

Fig 2: Ambr® 250 high throughput perfusion system

MARCH-2021 21

For process intensification at manufacturing scale, singleuse stirred tank bioreactors which are capable

.of high cell density culture are required

Downstream

Purifying a mAb produced in intensified cell culture is more straightforward than a VBV and downstream processing of VBVs is currently where bottlenecks occur. VBVs need to be purified generally from a cell lysate and where lytic viruses are being produced there is a large amount of debris associated with high cell densities and virus titers that requires a range of technologies to remove the debris, a classic example of this is adenovirus. However, if enveloped viruses including SARS-CoV-2 , Modified Vaccinia Ankara (MVA) and measles are being produced, cell lysis does not occur, and debris is less of an issue. These VBVs are instead more shear stress sensitive and this must be taken into consideration during downstream operations. (see Figure 4 for a workflow of technologies that could be used to purify VBVs cultured in intensified cell culture).

Harvest and Clarification

For downstream clarification of VBVs produced in intensified cell culture by either enveloped,shear sensitive viruses for example the SARS-CoV-2 or measles virus or lytic non-enveloped viruses including adenoviruses, cell harvest and clarification can become a bottleneck. High cell densities (>-20 × 106 cells/mL) present a number of challenges because increased cell numbers produce an increase in host cell proteins (HCPs), DNA and protein aggregates, which can foul and clog filters, requiring sizeable filter areas and large buffer volumes for VBV purification. The most common option to help remove excess DNA before filtration is to use nuclease, but this is an expensive enzyme, and if a large amount of DNA is present then grams of nuclease could be required making the manufacturing process prohibitively expensive. One alternative to using nucleases with lytic viruses, such as adenoviruses being used to produce SARS-CoV-2 vaccines candidate is to use flocculants and centrifugation.

Centrifuges : Centrifuges that operate by balancing out centrifugal force and medium flow to keep cells contained in an expanded bed are recommended, as these exert lower sheer forces on the viral product to minimize loss of infectivity. If classic filter trains do not work or a huge surface area is required, centrifugation is advised as the first step in cell harvest for high cell density as it reduces the filter area, eliminating pre-rinse steps to efficiently separate cells out, enabling the use of smaller footprint facilities where less buffer volume and buffer storage are required. A suitable centrifuge for this application is the kSep® single-use, sterile centrifuge (Sartorius) which has been shown to efficiently clarify high cell density mammalian cell cultures (> 200 × 106 cells/mL). This type of system is ideal for enveloped viruses, however when lysis occurs, additional experiments and the use of flocculants should be considered because this centrifuge operates at a maximum g-force of 2000 G, which may be an insufficient force to sediment all the debris.

Vaccine Production

25 March -2021

MARCH-202122

Vaccine Production

22

Upstream

Cell and Media Selection

Cell line and media selection are critical for intensified processing of VBVs because some cell lines, sub-clones and media perform better in intensified processing than others There is published information about how to intensify Chinese hamster ovary (CHO) cell lines (Mueller 2019, Zijlstra, 2019), the cell line of choice for mAb production, but this is rarely utilized for VBVs and is not currently being used for manufacturing any SARS-CoV-2 vaccines. Cell line: HEK293, Vero, MDCK: Virus: SARS-Cov-2, Adenovirus, Measles, MVA. For VBVs, the most commonly used cell lines are human embryonic kidney (HEK293) cells, (mostly used for viral vectors), or Vero and Madin-Darby Canine Kidney (MDCK) cells for inactivated or live attenuated viruses. The cell culture process for VBVs is also different to that for mAb production as cells needs to be infected with virus to produce a VBV. If process conditions are not closely monitored|controlled and there is a slight difference in, pH, DO (dissolved oxygen) or temperature between batches, it could affect the virus’ ability to infect the cells or the virus’ genetic stability, suppressing expression of viral antigens, often resulting in lower VBV yields and potency.

One strategy to determine the optimum cell line, sub-clone and media combination for VBV intensified cell culture is to screen different media, feeds and sub-clones to determine the most suitable combination for maximum productivity early in the culture process, as this can significantly reduce development timelines during scale-up.

Optimization : traditionally involves shake or spinner flasks to select the best combination of media|feeds and sub-clones. However, shake and spinner flasks provide no Process Intensification Equipment Technology Mode of operation - Single use - Automation - Plant footprint - Higher yield - Higher throughout - Less buffer| waste - Integrate unit operations - Continuous or semicontinuous control over pH and DO, and the mixing environment is unlike that in a bioreactor. Additionally, these flasks are often manipulated by hand, making it difficult to perform feeds or sampling without introducing variability. Hence, their use can often result in different cell growth and viral protein expression profiles to those seen in scale-up. Due to issues of cost, throughput, and resources, it is difficult for scientists especially those in academic laboratories where a number of SARS-CoV-2 vaccines are being developed to evaluate multiple sub-clones media, and feed combinations for intensified processing. As a result, typical sub-clone and media ranking processes can involve several rounds of batch and fed-batch flasks to reduce an initially large numbers of combinations down to a manageable number (typically around six) that can be tested for process development in benchtop bioreactors. This manual approach can take several months to complete and is extremely labor intensive. Additionally, the final choice of sub-clone, media, and feeds maybe sub-optimal for process intensification and may not generate VBVs with the highest yield, making this approach unsuitable when timelines for robust process development need to be accelerated. Methods of running intensified cell culture conditions in parallel at small scale are desirable to perform full Design of Experiments (DoE) of cell lines and media for VBV production. The use of automated microbioreactor systems capable of running as high inoculation fed-batch and|or perfusion mimics such as the Ambr®15 technology (Sartorius) which can monitor and control up to 48 microbioreactor cultures in parallel provide such a strategy.

March -2021

MARCH-2021 23

March -2021

Vaccine Production

Fig 4: Technologies for intensified downstream purification of viruses for VBV production

Fig 5: UV 280-nm chromatograms from reference resin (a) and Sartobind membrane (b); experiment was conducted with a 20-mL Q resin column and a 3-mL Sartobind Q (8-mm bed height). Resin and membrane first were sanitized with NaOH 1 M, then equilibrated with Tris-NaCl buffer. Virus load was 1.7 × 1012 virus particles (VP)/mL, and step elution used the same Tris buffer with increased NaCl concentration.

26

MARCH-202124

The most common option to help remove excessDNA before filtration is to use nuclease, but this is anexpensive enzyme, and if a large amount of DNA is present then grams of nuclease could be required

Following centrifugation, filtration is generally required for clarification, and the use of filters without any virus adsorption properties is essential to avoid loss of infectivity. An inorganic filter aid with high capacity such as Sartoclear® (Sartorius) can be used for purification of VBVs from very dirty cell supernatants but since this filter has adsorptive properties, operating conditions such as pH and salt have to be fine-tuned, to avoid virus adsorption at this stage. A Sartopure® PP3 filter (Sartorius) can also be used for clarification as many viruses will not adsorb to it, due to its very low specific absorption properties. This filter has been shown to achieve 100% virus recovery and high throughput for adenovirus processes (Boulais et al 2018), indicating it could be suitable for purification of a SARS-CoV-2 vaccine candidate produced by intensified processing. There is currently no plug and play harvest and clarification solution for all VBVs and scientists need to test different flocculants and filters to find the optimum combinations for use in their intensified processes.

Vaccine Production

March -2021

Fig 3: Intensified seed train and scale up for manufacture of VBVs (Viral Based Vaccine)

27

MARCH-2021 25

28March -2021

Vaccine Production

Purification and formulation

Fast production is now a major driver for producing a SARSCoV-2 vaccine in an intensified process and reducing the amount of buffer is critical to manufacturing in smaller sized facilities. Purification of high titer VBVs propagated requires technologies that have high binding capacities and low fouling capabilities.

If these types of technologies are not adopted, large buffer volumes will be required, which need larger storage and manufacturing areas. The challenge is always to develop simplified purification processes that use as little buffer volume as possible. For example, the initial purification steps can use ultrafiltration with Tangential Flow Filtration (TFF) membranes which offer low fouling, high throughput, and a higher cutoff membrane of 300kDa. TFF membranes are available in two different materials, cellulose-based Hydrosart® and polyethersulfone (PESU) polymer-based. Hydrosart® has the unique property of being very hydrophilic thus preventing viruses from adsorption to the membrane. Both membrane types allow removal of low molecular weight impurities, to reduce the numbers of subsequent unit operations.

When using high titer VBVs, it is important to select the right buffer formulations for purification and there are small scale systems such as the Ambr® crossflow system (Sartorius) which allows scientists to perform high throughput screening of buffers to evaluate viruses, buffer combinations and process control conditions. This helps improve early stage R&D productivity and efficiency, while helping to reduce buffer volumes required for the screening experiments.

membrane adsorbers: With high binding capacity in mind, membrane adsorbers can be used in place of conventional resin-based affinity chromatography for purification of VBVs (Weigel at al 2016). Membrane adsorbers with beads that have large pore sizes (3-5 µm) are recommended as these provide maximum ligand accessibility for viruses and eliminate the need for diffusion through resin pores. Membrane adsorbers with large pore sizes such as Sartobind® Q can operate at volumetric flow rates that are typically 20-fold higher than classical resins and studies with adenovirus have shown that compared with resins, they can achieve a 10-fold higher viral binding capacity using 58% less buffer, without compromising virus purity (Abrecht et al 2019).

Ready-to-use membrane adsorbers are ideal for virus capture with VBVs as they are quick and easy to operate because column packing, as well as cleaning and related validation activities are eliminated. They also have a small footprint and are single-use, which reduces cross contamination risks, and can lead to significant time and cost savings. For example, Sartobind® Q has been used for adenovirus purification and has achieved a loading capacity of 6.4 × 1013 virus particles/mL of membrane and reduced DNA concentration in the process stream to 0.7 ng DNA/ dose (Boulais A. et al 2016). Similar results were obtained by GSK, where scientists reduced DNA by a log reduction value (LRV) of >4, and product recovery ~90% (Abrecht et al 2019), indicating that this membrane adsorber could be used for purification of a SARS-CoV-2 vaccine produced by intensified processing.

membrane filtration- For final polishing and formulation of high titer viruses, membrane filtration using stabilized cellulose membranes is suitable as these membranes are hydrophilic, which limits fouling while maximizing membrane flux performance and virus yield.

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Vaccine Production

To optimize downstream capture and purification steps, monitoring of inlet and outlet virus concentration

and quality is required to select the best purification parameters.

Summary

Intensified processing enables VBV manufacturers to utilize single-use technologies and manufacturing facilities with increasingly smaller footprints, which could be used to rapidly produce vaccines for the current SARS-CoV-2 pandemic. However, it does require upstream and downstream tools that are capable of culturing and processing high cell densities and high virus titers. In summary, developing an intensified process for a VBV should start with the end in mind, first selecting the optimum media and cell line, to intensify the process and seed train. Then selecting the appropriate technologies in the downstream to ensure the highest virus recovery, using chromatography membranes and single-pass ultrafiltration and diafiltration, as well as monitoring and controlling the process with rapid viral quantification, PAT and MVDA data analysis software. Starting intensified processing with the end in mind, could help ensure rapid manufacturing of large numbers of doses of VBVs such as a SARS-CoV-2 vaccine produced by intensified cell culture in a fully closed process that could be run in a small bioprocess facility. Sartorius offers a range of proven upstream and downstream technologies, which when connected and optimized have the potential to deliver this vision.

30March -2021

MARCH-2021 27

Vaccine Production

Membranes which can be used include Hydrosart® (Sartorius) which has previously been shown to have an improved chemical stability coupled with adenovirus recovery of up to 90 % (Boulais et al 2018). The hydrophilic nature of the membrane also prevents adsorption of the virus or important components in the final formulation buffers. These membranes come in scalable single-use cartridges and/or self-contained units, which can be used with automation on movable skids indicating that this membrane could be used as a flexible method of producing clinical to manufacturing batch sizes of an adenovirus based SARS-CoV-2 vaccine produced by intensified processing.

.

Virus Analytics

To optimize downstream capture and purification steps, monitoring of inlet and outlet virus concentration and quality is required to select the best purification parameters. This can be achieved by Q-PCR or using no-wash staining assays, for example Combo Dye® reagent or the antibody-based ViroTag® (Artinger et al 2016), which can be detected automatically in flow cytometer-based technology such as the Sartorius Virus Counter® 3100 system (Figure 6). Speeding up the analytical response and understanding of which experiments should be prioritized, reduces analytics downtime, allowing faster process development timelines.

Purification of high titer VBVs propagated requires technologies that have high binding capacities and low

fouling capabilities.

29 March -2021

Fig 6: Virus Counting Technology

MARCH-202128

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MARCH-2021 29

Imprint surveyed processing equipment and packaging launched by major brands globally in 2020. We list, in this article, critical steps in production units that are common to most production units. Imprint selected TOP machines in each category fulfilling criteria of innovation and safety, apart from speed and productivity. In this article out of 23 critical common manufacturing steps we have features SIX processing equipment categories. In future issues Imprint shall feature TOP launches in 2020 of the balance categories of critical com-mon steps in manufacturing.

Top Global Pharma Production & Packaging Machinery – 2020

Pharmaceutical manufacturing is a highly controlled and regulated environment. Almost every process can be automated; and there is a piece of pharmaceutical manufac-turing equipment involved in every step. Below, we have highlighted some common

equipment used in solid dose (tablet and capsule) and liquid pharmaceutical manufacturing:

Processing equipmentAgitators: To mix liquids, to promote chemical reactions and to increase heat or cooling transfers.Blowers: Used in solvent recovery and other evaporation applications.Boilers: To create steam by applying heat energy to water.Capsule equipment: Different equipment is available to fill, polish, and sort capsules.Capsule and tablet printers: For printing information like drug names or dosage on the cap-sules or tablets.Centrifuges: Used for separation of liquids of different densities, or for separation of liquids from solids.Chillers: To quickly lower temperatures.Coaters: To coat tablets or capsules with films like a sugar film.Cooling towers: Used for cooling liquids or condensing steam.Dryers and Granulators: For drying liquid preparations into powders or granules.Heat exchangers: Used to transfer heat from one medium to another.High Pressure Homogenizers: The most efficient fluid processing equipment for particle size reduction and cell lysis.Inspection machines: Allow for visual inspection of the product as it is moved along by rotat-ing rollers.Metal detectors: For detecting tramp metal (bits of metal like nuts, screws, or broken frag-ments of machinery) that may have contaminated the product.Mixers:For blending and particle size reduction.Ovens: For providing necessary heat or drying.Pulverizers / Cone mills:Particle size reduction equipment for granules.Tablet press: For producing tablets.

Tablet deduster: For removing any dust created in the tablet press. Often also polishes the tablet.

Sifters: For sieving powders or granules.

Spray coating machines: Used for spray coating liquid onto a powder.

Tanks: For holding liquids.

Bin Lifting Charging Machine: used as a lifting and charging equipment for various tablet compressing ma-chines, capsule filling machines, mixing machines and tablet counting machines

Packaging equipmentBlister packers: Designed to pack tablets, capsules, softgels, injection solutions, syringes and other small medical items into blister packs. “Deblistering” machines are also available to recover tablets, capsules or softgels from blister packs.

Bottling and filling lines: For filling bottles with liquids or containers with tablets, capsules or softgels.

Cappers: Designed to place caps onto filled bottles or containers of medicines.

Cartoners: These sophisticated machines can fill small medicine boxes with blisters packs, fold and insert leaflets, and close, code, and seal the box

Counters: Counts capsules, tablets, softgels and any other small, solid items.

Induction Sealers: Seals aluminum foil seals to the bottle mouth.

Labeling equipment: For attaching or printing labels onto the packaging of boxes, bottles, containers, tubes etc.

Tube fillers: For filling and sealing tubes of ointments, creams and gels.

Pharmaceutical Tablet and Capsule Printing Machine from AckleySingle or Double Sided Printing with independent graphics for each sideSingle lane, rotogravure product marking system that uses edible printing inks to print logos onto the outer coating of pharmaceutical, nutraceutical and confectionery products for identification, counterfeit protection, and brand recog-nition. Designed for effortless continuous operation, and produces accurate and repeatable results with minimal user interaction or downtime.

Programmable settings for up to 50 products

VIP Printer

Features:• Single-lane carrier link system• Safety enclosure with interlocked doors• Servo based motion with optical encoder position feedback• Carrier timing belt with precision machined pockets• Tool-free installation of carrier links• Adjustable hopper assembly for quick changeover between

products• Patented hopper air-assist feature & clean air filtration system• Articulated swing arm with 17” touch-screen HMI• User friendly interface

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• Programmable settings for up to 50 products• Portable with a small footprint• Low maintenance cost• Worldwide customer support• Toolkit included

Capabilities• Output Up to 60,000 / Hour• Single or Double Sided Printing with independent graphics for each

side• Single Sided marking using time proven rotogravure printing• Ability to print alpha-numeric text or graphic logos• Ability to print with solvent or water based ink solutions• Ability to print in multiple ink colors

Tablet Inspection Machine - Capsule Inspection Machine from Shree Bhagwati

Tablet Inspection Machine - Capsule Inspection MachineTablet/caplet, Capsule to be inspected are fed in hopper. Tablet gets placed automatically on the nylon conveyor through vibrator. The tablet move along the other face of the tablet is inspected during. its motion on the convey-or. Optional Dust extractor provides collects the dust. Rejection tablet trays are filled to collect rejected and 100% perfect tablets fall into the collection drum. Quality of the equipment, constant innovation and improvement with a focus on service are Shree Bhagwati major assets.

Food grade material used for plastic and rubber componentsSpecial Features of Tablet/Capsule Inspection Machine• We offer CE Certified machine• Inspection Machine with contact parts Stainless Steel 316• Suitable for various size and shapes of tablets / capsules• Food grade material used for plastic and rubber components

LabStar Laboratory Agitator Bead Mill from NETZSCH Premier TechnologiesThe multi functional laboratory mill LabStar enables scientific academic work on difficult research and development tasks and impresses with its easy handling.

Data collection by specially developed software LabDat©The laboratory mill LabStar is the smallest grinding mill that enables an exact scale-up to comparable production machines.

Features:• Sealing of the grinding chamber by double-acting mechanical seal• Swiveling grinding tank facilitates filling and emptying of the grinding media• Easy cleaning• Drive of the agitator shaft and pump via frequency inverter• Operating terminal with display indication of the operating parameters• Data collection by specially developed software LabDat©• High reproducibility• Exact scale-up

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Bin Lifting Charging Machine from GMPMAXApplication: JT Series bin lifting charging machine is new equipment developed to meet the need of vertical lifting of material in the modern pharmaceutical process. It can be used as a lifting and charging equipment for various tab-let compressing machines, capsule filling machines, mixing machines and tablet counting machines, there are many types of machines in JT Series for users to select and use, such as fixed lifting type, mobile lifting type, and mobile lifting turnover type.

Bin Lifting Charging Machine

Working principlePush the hopper into the lifting arm which will lift or lower under electrical and hydraulic control, thereby carrying out the lifting, transfer and charge of material.

The medicine is transported in a tightly closed state, thus avoiding contamination during transportation.

Features:• High-tech equipment that integrates machinery, electronics and hydraulics into one body, with compact design

and runs stably and reliably.• The barrel body is made of quality stainless steel which is highly polished on inner and outer surfaces, without

dead corner and conforms to the requirement of GMP.• The fixed lifting type column frame can turn in a certain angle; the mobile lifting type can be freely moved in

the working place, and the movement is convenient and flexible; the mobile lifting turnover type can be de-signed and manufactured to have a lifting charging arm that fits to the user’s original material barrel, so that the charging arm can tightly clamp, lift the barrel and can make 180°turnover.

• The material barrel can be used as a batching and storage barrel in the upstream procedure and as a charging hopper in the downstream procedure (compressing, filling and counting).

• The medicine is transported in a tightly closed state, thus avoiding contamination during transportation.• The patented discharge valve is compact, convenient to discharge and easy to clean.• It has thoroughly changed the traditional mode of manual operation, reduced the labor intensity, and the tightly

closed production has avoided flying upward of dust and cross contamination during transportation. It fully con-forms to the requirement of GMP.

• During the process of charging, there is no phenomenon of layering of material.

Main technical parametersMode

Volume of lifting hopper(L)

Weight of material lifted (kg)

Motor power (kW)

Lifting travel (mm)

Height of equipment (mm)

JT-100

100

100

0.75

The high of equipment, lifting travel can be designed and manufactured according to user’s requirements.

The high of equipment, lifting travel can be designed and manufactured according to user’s requirements.

JT-200 JT-300 JT-500 JT-800 JT-1000

1000

1000

4

800

800

3

500

500

2.2

300

300

2.2

200

200

1.5

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Single Point Scale Centrifuge from Ace IndustriesSingle Point Scale Centrifuge designed in accordance with international quality standards, we provide these products in different models and specifications at most competitive prices. We also check these products properly to eliminate defect, if any. To ensure safety during transit, we pack this Single Point Scale Centrifuge using quality material.

Basket speed: 900 RPMFeatures:• Excellent performance• High productivity• Low maintenance and power consumption

Single Point Scale Centrifuge

Technical Specifications:• Basket size: 12â€� (300mm)

dia. x 8â€� (200mm) depth• Basket speed: 900 RPM• Capacity: 6 lit.• G-Force: 230• Motor: 0.5 HP x 1440 RPM• Mouth dia: 230 mm (10 in.)

APV Model 1000 Homogenizer from APV, an SPX BrandFeatures an easy-to-read digital pressure display and electronic pressure safety systemCompact, versatile design specifically developed for R&D laboratories within the dairy, food, chemical, pharmaceutical, cosmetic and biotech industries

APV Model 1000 Homogenizer

Features:• Unique, knife-edge dual function homogenizing and cell disruption valve

helps deliver superior emulsions, dispersions or harvest of intracellular products

• Available two-stage homogenizing valve can be specified in either tung-sten carbide or ceramics

• Features an easy-to-read digital pressure display and electronic pressure safety system

• Small footprint – suitable for benchtop location• Field-replaceable and reversible tungsten carbide pump valve seats• Smooth, quiet and reliable operation• Item - APV Model 1000 Homogenizer• Company - APV, an SPX Brand• Catalog Number - Model 1000• Capacity - 22 L/hr• Motor Type - TEFC. 3 KW• Quantity - EA• Type - Displacement pumps

MARCH-2021 35

Automatic Blister Packing Machine from Jicon IndustriesEasy and quick change over reduces material wastage and down time

BLISTRIP–I xt is a single track automatic blister packing machine for packing of tablets, capsules, dragees etc., in blis-ter packs using PVC-Alu packaging materials. The Blister Forming, Product Feeding and Sealing operations are con-tinuous by rotary motion while the indexing and punching operations are of intermittent reciprocating motion.The output capacity of the machine depends on the product characteristics. In case of slightly curved or flat tablets up to 10mm dia an output of 150 packs per minute can be optimally achieved.

In-built water chiller as standard

Features :

Combi packs possible for better utilization of capacity and packaging materials

• Edge – to – edge cutting to eliminate trim waste between packs• Special tool design reduces trim waste• Continuous blister forming at low temperature by contact heating system• All change over parts and adjustments accessible from front side• In-built water chiller as standard• Easy and quick change over reduces material wastage and down time• Simpler operation reduces operator fatigue – increases output• Very compact in size

BLISTRIP–I xt

Specifications:Max. Web Width - 148 mmMax. Forming depth - 10 mm (Ex-pandable up to 20)Max. output: Packs/Min - 150 (1 UP), 300 (2 UP)Max. Strokes/Min - 150

Automatic Capsule Tablet counting machine line from Neostarpack

TC4100/RT1060/RT2060

Automatic capsule counting machine equipped with automatic bottle-feeding turntable that transporting the bottles to the counting machine and outfeed turntable though conveyer, reducing the repetitive workforce on placing and picking the bottle manually. Different from its tabletop, single machine, version, the turntable made this production line more efficient. Compact de-sign makes it suitable for limited space and easy to change over for different product. Suitable for extensive fields of industries, including pharmaceutical, food, chemistry and cosmetics. Application include bottled gums, vitamin, pills, capsule, tablet, fish oil, candy…etc.

Fit for counting coated capsule, pill, tablet and particle.

MARCH-202136

SPACE/ MANPOWER-SAVING COMPACT DESIGN AUTOMATIC COUNTING MACHINE LINEThis tablet counter has high accuracy, and either vibration speed or counting quantity is adjustable depending on your need. Furthermore, to meet your requirement, bottle infeed/outfeed speed of the turntables are adjustable. The size of star wheel is also customizable. All part surface that contact with your product is made of stainless #316, which meets high standard of pharmaceutical industry. Capping machine, sealing machine and round bottle labeler are also available to upgrade your fully automatic production line.

Features:• Automatic counting line equipped with infeed / outfeed turntable. Saving your time and manpower.• Easy to maintain; simple to clean.• Multiple parameter setting adjustable: Quantity of bottle/ capsule, Goal amount of bottle/ capsule.• Automatic counting recorder let you see the exact bottle/ capsule counting number.• Moveable design for equipment rearrangement/ expansion to fully automatic counting filling production line.• Adjustable conveyor speed, product infeed/outfeed speed, and counting speed.• PLC programmed HMI system with colored touch screen and clear display allows convenient operation.• Fit for counting coated capsule, pill, tablet and particle.• Dust accumulating device for smooth, efficient and accurate counting

Automatic Single Head Bottle Screw Capping Machine from Lodha InternationalSingle Head Bottle Screw Capping Machine Model: LI-BCS 1 is suitable for Round Bottles with maximum speed of 40 Bottles per minute. Single Head Bottle Screw Capping machine specially designed in Stainless Steel finish including machine M.S. frame structure with Stainless Steel Cladding/Enclosures.

Various safety features including Clutch system to avoid Bottle Breakage or Jamming

Single Head Bottle Screw Capping Machine is equipped with Orientation type Cap Feeder for continues feeding of Cap for online operation on any liquid or powder filling line Single Head Bottle Screw Capping Machine suitable for various sizes of Bottles as well as Screw Cap with the help of change parts. Capping Machine is suitable for applica-tion in Pharmaceutical, Food, Pesticides, Chemical, Beverages, Liquor and other packaging industries having lower production requirement with automatic online operation.

Single Head Bottle Screw Capping Machine Model: LI-BCS 1

SPECIAL FEATURES OF AUTOMATIC SINGLE HEAD BOTTLE SCREW CAPPING MACHINE

• No Bottle - No Cap System• No Cap - Machine Stop System• Machine construction in Stainless Steel Finish• Cap Feeder with Variable Speed System for feeding control of caps.• Hopper can be completely dismantle for easy cleaning• Various safety features including Clutch system to avoid Bottle Breakage

or Jamming• Single Drive synchronizing operation of Conveyor and Star Wheel• Minimum Change over time

MARCH-2021 37

High capacity capsule filler from SejongThe comprehensive AWC (automatic weight control) functions reject any doses that are not filled within tolerance, as well as automatically rejected any faulty capsules that have not fully closed, or where the capsule sleeve has been damaged.

F180 Series

Highest performance capsule filler for large volume production lineThe Sejong Pharmatech F180 series is a high capacity capsule filling solution with cutting edge features that can operate at up to 184,000 units per hour.

The F180’s proprietary drive system has been designed to offer maximum speed and performance whilst minimizing maintenance through reduced vibration. In addition, the modular nature of the system allows for rapid and straight-forward replacement of individual components, keeping downtime to a minimum.

High capacity machine for demanding production lines that fills 184,000 units per hourFurther innovation includes the provision of an automated capsule jam removal system. Using high pressure air, the machine can self-clear without the need for any disassembly, saving valuable time. Because increased speed must not lead to a reduction in quality, the F180 is fitted with a 5 stage compression moulding system to ensure the opti-mum capsule fill even at highest speeds.

In addition, the comprehensive AWC (automatic weight control) functions reject any doses that are not filled within tolerance, as well as automatically rejected any faulty capsules that have not fully closed, or where the capsule sleeve has been damaged.

To meet your exact needs and offer full flexibility, the F180 is able to handle a wide variety of encapsulated dosage types, including powders, pel lets and tablets. It can also fill capsules with a mixture of these doses, allowing scope for the production of a large number of products.

The control system is fully 21CFR part 11 compliant, with graphical touchscreen control for ease of operation and monitoring of performance.

BENEFITS FOR YOU• High capacity machine for demanding production lines that fills 184,000 units per hour• Reduced maintenance power train minimises maintenance and downtime• Automatically removes capsules jams without operator intervention• Superb accuracy thanks to advanced AWC system with automatic rejection• Fully 21 CFR part 11 compliant graphical control and recording system

Cartoner from Ulhman group Servo-regulated leaflet index and product loading for process reliabilityFlexible and EfficientAn intermittent motion cartoner of the latest machine generation with exceptionally straightforward operating func-tions. Maximum reliability for the packaging of blisters, bottles, vials, or pillow packs, for example.

MARCH-202138

Maximum output- 150 cartons/min.Highlights• Servo-regulated leaflet index and product loading for process reliability• Carton magazine for approx. 1,500 cartons• Rotary carton pick-up with mechanical pre-break function allows the processing of practically all carton qualities• Interchangeable closing station: easy changeover from tuck-in to hot-melt closure• Fast format changeover as few, easily replaced format parts

Cartoner C 2155

Induction Sealing Machine from Dhara EngineersInduction Sealing Machine offered by the company is a simple and reliable method of bottle sealing. It welds an aluminum foil seal across the bottle neck, to prevent leakage of the product. This machine provides tamper evidence and improves product shelf life due to the excellent barrier properties of the foil and its airtight seal onto the container. This machine also improves pack presentation and customer acceptance. These machines are con-trived with supreme grade of raw material of stainless steel and sophisticated machines and we do complete quality inspection of these sealing machines before delivering at the client’s end. These machines can be custom designed according to the requirements of our respected customers. These are made according to the quality standards and are offered to our clients at their pocket friendly prices

Induction Sealing Machine

Features and Advantages of Induction Sealing Machine• Less power consumption.• Easy installation and operation.• Ejection plastic iron housing.• High sealing speed, suitable for volume-produce.• Convenient for use, good sealing quality, work continuously.• This machine seals caps through foil that provides tight and strong seal and is unaffected by grease, powder, or

moisture contamination.• Each function of Induction cap sealing machine is labeled clearly, which makes it easy and simple for the user.

Keywords: Pharmaceutical Tablet, rotogravure printing, Capsule, Printing Machine, Ackley, pharmaceutical, VIP Print-er, edible printing inks, Tablet Inspection Machine, Capsule Inspection Machine, Shree Bhagwati, LabStar, Laboratory Agitator Bead Mill, Agitator, NETZSCH Premier Technologies, Bin Lifting Charging Machine, GMPMAX, pharmaceuti-cal process, Centrifuge, Ace Industries, Single Point Scale Centrifuge, homogeniser, R & D labs, pharmaceutical, SPX Brand, Automatic Blister Packing Machine, Jicon Industries, tablets, capsules, dragees, PVC-Alu packaging, tablet counting machine, capsule pill tablet counter, pharmaceutical, HMI system, Screw Capping Machine, Lodha Inter-national, LI-BCS 1,High capacity capsule filler, Sejong, Production Line, F180 Series, Cartoner, blisters, bottles, vials, pillow packs, Ulhman group, Induction Sealing Machine, bottle sealing, Dhara Engineers, aluminum foil seal

MARCH-2021 39

40

April Issue

Cover Story

Vaccine Production

Vaccine Packaging

Top Global PharmaProduction and

PackagingMachinery – 2020

Tanks; Spray coating machines; Sifters;

Tablet dedusters; Tab-let press; Pulverizers; Capsule equipment

Promatic PC 4000 horizontal Cartoners from Romaco

Editorial Focus - Pharma Production Machinery:

R & D Laboratory Requirements

Editorial Focus - Pharma Packaging:

Automatic Boxing (Tablet Carton)

MARCH-202140

Imprint BlogSubject: Vaccine Production - new trends and innovation in large scale vaccine manufacturing pro-cess. Bloggers are invited to focus on latest process equipment. Vaccine manufacturing technologist let us have your insights and process techniques. That result in your plant achieving excellence. Please include your name and email- id.

MARCH-2021 41

LIST OF LICENSED HUMAN VACCINE MANUFACTURING FACILITIES IN INDIA1. Bharat biotech International Ltd, Hyderabad

2. Biological E; Azamabad, Hyderabad

3. Biomed Pvt. Ltd, Ghaziabad

4. Cadila Healthcare, Moraiya, Sanand, Ahmedabad

5. Chiron Behering, Gujarat

6. Dano Vaccine & Biological Pvt. Ltd, Hyderabad

7. Green signal BioPharma Ltd, Chennai

8. Panacea; Baddi, Himachal Pradesh

9. Panera, Chandigarh

10. Ranbaxy Lab, Bangalore

11. Serum Institute of India, Pune

12. Shantha Biotechnics Ltd, Hyderabad

13. GSK Asia Pvt. Ltd, Nashik

14. Sanofi Pasteur India Pvt Ltd, Navi Mumbai

15. BIBCOL, Bulandshahr, U.P

16. Haffkine, Mumbai

17. Human biological institute; Gaachibowli, Hyderabad

18. Human biological institute; Udhagamandala, Tamil Nadu

19. HLL Biotech Ltd, Chennai

20. BCG vaccine, Chennai

21. CRI; Solan, H.P

22. Pasteur institute of India, Tamil Nadu

MARCH-202142

Machine Manufacturers and Media Planners

• Advertising your machine in imprint would be the best decision in assuring your ad spend will give you ROI- Return of Investment.

• The Digital magazine can deliver your cam-paign interactively to our readers in many ways.

• Imprint magazine content will of course pro-mote your machinery in regard to features and Specifications. However, Imprint will also feature installations and actual-user stories to provide in-depth appreciation of your ma-chinery to industry and professionals.

Editorial Calender

• Through links on the digital magazine you can take our readers to where you want them, to see videos, of your own manufacturing unit at actual user sites or in demo condition.

• Become an advertiser in Imprint and start a productive relationship to enhance your business.

Advertising Rates

• Lets go social shall we? Use our social media to pump up the jam on your brand and innovation.• There are ways and ways, and imagination is the key.• Digital is the key, and brand building is the key• Mailer blast from Imprint are carefully sent to ensure they are treated with respect and followed through

with constant connect via instagram, twitter, facebook.• Please study our media kit. There are half pages, column sizes and various other opportunities to advertise.

It isn’t necessary to always think just of a full page ad!!• We have banner ads on the website as well. Use your imagination to build a campaign that catches eye

balls.

MARCH-2021 43

Imprint-pharma production machineries an interactive digital magazine though working on its core principal of encouraging the market to adopt the most cutting-edge pharma production and packaging machinery also under-stands the importance of R and D lab Requirements. It is known to all how crucial is role of lab equipment in terms of data, analysis and insight and how it can be a game changer if there is constant progression and familiarity with the technological advancement occurring in the world.

Imprint in its upcoming April 2021 issue will feature Top R & D lab equipment from major brands contributing the sector in its best capacity.

In line to its commitment Imprint will carry-on to cover the Vaccine Production process and in its future issues and Top Global Pharma Production and Packaging Machinery -2020

For advertisement opportunites contact:

Advertising Manager: Gayatri Pal

Contact: 9821135542

MARCH-202144

Machine Manufacturers and Media Planners

January

February

March

April

May

June

July

August

September

October

November

December

Instrumentation and process control

Plant design and engineering, process technology

Encapsulating top global news in previous year

R & D lab requirements

API machinery

Powder filling machine

Plugger and capper

Compact dehumidifier and clean room systemsSyringes

Tableting

Capsuling

Liquid syrup manufacturing plant

Packaging Editorial Calender

January

February

March

April

May

June

July

August

September

October

November

December

Bottling tablets

Blister packaging of capsules

Drops bottle

Automatic boxing (tablet cartons)

Vials filling

Labelling

Ampoules tray

Laser printing

Pallet shipper

Cartoning

LDPE and PET plastic bottles

Powder mix and sachets

MARCH-2021 45

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MARCH-202146

Advertising Rates for Website

• HomepageTop left banner -250 x 321 px : Rs. 20,000

Bottom left banner - 265 x 321 px : Rs. 19,000

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STATEMENT ABOUT OWNERSHIP AND OTHER PARTICULARS OF IMPRINT MAGAZINE REQUIRED UNDER RULE 8 OF THE REGISTRATION OF NEWSPAPERS (CENTRAL) RULES 1966 FORM - V (SEE RULE 8)

1.PLACE OF PUBLICATION :MUMBAI

2.PERODICITY OF ITS PUBLICATION:MONTHLY

3.PRINTERS NAME:ANIL CHOPRA WHETHER CITIZEN OF INDIA : YES ADDRESS : 106 STANFORD PLA-ZA, OFF NEW LINK ROAD, ANDHERI (W), MUMBAI - 400 053

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5.EDITOR’S NAME:ANIL CHOPRA WHETHER CITIZEN OF INDIA : YES ADDRESS : 203 RUSHAB TOW-ER, 100 ST BARAZ ROAD, VILE PARLE (W), MUMBAI – 400 056

6.NAME & ADDRESS OF INDIVIDUALS WHO OWN THE NEWSPAPER:INFOCAST SYSTEMS PRIVATE LIMITED

SHARE HOLDERS HOLDING MORE THAN ONE PERCENT OF TOTAL CAPITAL:

ANIL CHOPRA

FLAT NO. O3, 2ND FLOOR, AJANTA BLDG, L.D. RUPAREL MARG, MALABAR HILL, MUMBAI 400006

ANURADHA CHOPRA

FLAT NO. O3, 2ND FLOOR, AJANTA BLDG, L.D. RUPAREL MARG, MALABAR HILL, MUMBAI 400006

CHAITANYA CHOPRA

FLAT NO. O3, 2ND FLOOR, AJANTA BLDG, L.D. RUPAREL MARG, MALABAR HILL, MUMBAI 400006

I, ANIL CHOPRA HEREBY DECLARE THAT THE PARTICULARS GIVEN ABOVE ARE TRUE TO THE BEST OF MY KNOWLEDGE AND BELIEF.

DATE 15.3.2021

SD/-

ANIL CHOPRA

PUBLISHER

MARCH-202148

May Issue

Cover Story

Vaccine Production

Vaccine Packaging

Top Global Pharma Production and Packaging Machinery – 2020

Blower; Boilers; Chillers; Cooling towers Coaters; Dryers and Granulators; Heat Exchangers Metal detectors; Mixers; OvensEditorial Focus: API MachineryVials Filling

MARCH-2021 49

RNI nNo.6178/61