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Low temperature sterilizerMatachana 130LF

International standards for LTSF sterilization• Design, performance & testing: EN 14180. Product standard containing

minimum requirements and test methods to ensure a safe and efficient LTSF process. Harmonized with the Medical Device Directive.

• Operation & process validation: EN ISO 25424. Standard covering requirements for development, validation and routine control of LTSF process.

• Safety requirements (for all types of sterilizers): EN 61010-1 andEN 61010-2-040, regarding safety requirements for electrical equipment for measurement, control and laboratory use, particular requirements for sterilizers and washer-disinfectors used to treat healthcare material.

Sterilizing solutioncontaining

only 2% of FA

Great performanceon long lumens andflexible endoscopes

LTSF Sterilizationtemperature of60 ºC or 78 ºC

Efficient, safe,comprising an excellent

penetration ability

Wide materialcompatibility

Material compatibility

According to ISO 17644, the medical device manufacturer must specify the requirements for a safe reprocessing of his products to guarantee that medical devices can be processed safely and will continue to meet its performance specification.

Additionally, MATACHANA has evaluated out of 38 different types of polymers most commonly used for medical instruments and other items.

MATACHANA has reached compatibility statements from several surgical instruments and endoscopes manufacturers worldwide.

Our innovative methodEvaporation of our sterilizing solution containing water with 2 % w/w formaldehyde into the sterilizer chamber is generating a sterilant comprising hydroxyl (-OH) groups, which, at temperatures above 50 ºC, are highly reactive to all kind of microorganisms by precipitation of protein and methylation of nucleic acids.

By use of the physical continuity principle for evaporation and careful control of the relevant physicochemical properties, i.e. pressure and temperature of the steam containing 2 % formaldehyde in the chamber, very stringent thermodynamic equilibrium conditions are maintained during the holding time.

The fractioned vacuum concept during the initial conditioning phase of the cycle, which is already well known and established in steam sterilization, is applied also for our LTSF-process on an equivalent level. This concept has verified an excellent sterilant penetration performance even for every complex structures and narrow lumen devices (e.g. 4 m long, 1 mm internal diameter).

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Main features

Installation drawings

Technical specifications 130LF-1 (1 door)

130LF-2 (2 doors)

Overall dimensions (mm):

Height

Width

Depth

1864

900

1156

1864

900

1234

Chamber useful dimensions (mm):

Height

Width

Depth

320

320

900

320

320

900

Power (kW) 7 7

Volume (liters) 145 145

Installation requirements:

Electrical supply:

400 V/3 ~/N/PE/50 Hz (optionally 200, 208 or 230 V/3 ~/N/PE/50-60 Hz)

Water supply for vacuum system:

Drinking water, conductivity < 1000 µS/cm, pressure: 4 bar

Water supply for demineralization cartridge:

DI-water or drinking water, 1-5 °F, pH 7-9, pressure: 4 bar

Drain:

Rust-resistant syphonic drain able to withstand a temperature of 70 °C

Compressed air:

Exempt of impurities and duly filtered, pressure: 5-7 bar

Compact design.Steam-formaldehyde gas mixture with low 2 % formaldehyde content.Fully automatic PLC-microprocessor control.Colour touch panel and two channel line recorder (temperature/pressure) at the loading area.Integrated water demineralizer and reverse osmosis treatment system.High performance two stages water ring vacuum pump with integrated ejector. Serial interface (RS232 ports) to connect our supervision software EasyLOOK or to other traceability softwares.Wheels to facilitate mobility.Alphanumerical printer to print all the relevant process parameters, messages and alarms (optional).Backlit frontal offering great visibility.Automatic supply and perforation system for sterilizing solution bags.

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LTSF process developed in MATACHANA sterilizer 130LF

LTSF process is a modified steam sterilization process that uses steam with the addition of formaldehyde as a sterilant (active agent). The process is carried out at subatmospheric pressure, with 2 different temperatures as per the selected cycle.

These are the main steps of the cycle:

1. Air Removal and AbsorptionTransport of the effective media. The sterilizing agent must reach all surface areas of the medical device which shall be treated, in sufficient quantity. The sterilizer executes different consecutive phases of formaldehyde steam injection pulses (pressure increase) alterning with vacuum stages (air removal).

2. Sterilization – Holding timeMicrobicidal interaction. The sterilizing agent must be available at defined concentration for a minimum of time at specified physical conditions. During this phase, the pressure in the sterilization chamber is kept at constant level via barometric adjusted pressure-control and re-feeding. During the entire reaction time of the media the sterilization chamber is automatically tested for tightness. If the pressure in the chamber exceeds a specific value above the working pressure (e. g. due to a leakage), a failure message is emitted.

3. DesorptionThe sterilizing agent and eventually further chemical reaction components must be fully removed from the medical devices by several vacuum pulses with steam. To do so, the air from the sterilization chamber is alternately evacuated and pure water steam is fed several times into the chamber. The program ends after a vacuum-drying phase and an aeration phase.Upon indication “Cycle End” the sterilizer may be opened and the sterilized materials unloaded and used with patients without extra-aeration needed.

1013 mbar(ambient)

215 mbar

53 mbar

(vacuum) Time

Pressure 60 ºC cycle profile

StartAir removal/absorption Desorption

Drying and aerationHolding time

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Programs and applications

Comparative chart between LTSF and Steam Sterilization

The LTSF process has certain similarities with steam sterilization, both cycles have also a similar profile but with the following relevant parameters differences regards to temperature, pressure and time.

1000

2000

3000

Pressure (mbar)

Steam (134 °C)

LTSF (60 °C)

Atmosphericpressure

0

Time

Test program

Vacuum test: Program to test tightness of the sterilization chamber.

Sterilization programs

Flexible endoscopes of all types, without restriction lumens, number of channels or diametersElectrical ScalpelsPHACO emulsifiersEpidural pressure cathetersBipolar cablesRX transductorsSternum sawsBiopsy bottlesX ray coverOphtalaser boxesOphtalaser gumsChondrotomeLong and narrow lumensUltrasound transducers, etc.

Rigid endoscopes and their accessoriesMicrosurgical instrumentsOphtalmological instruments, including PHACO emulsifiers ECG and electro cablesLight guides cables

60 ºC program: UNIVERSAL CYCLESterilization time: 30 minutes

In a general way, any material compatible with ethylene oxide sterilization is likewise compatible with the LTSF process.

78 °C program: Sterilization time: 10 minutes

Most of the materials that are sterilized with 60 ºC program could be also sterilized at 78 ºC. However, MATACHANA specially recommends this cycle for these type of items.

Of course, 78  ºC program can be used for non thermo-labile materials which are normally sterilized by steam as their shelf life is extended by this sterilization method.

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MATACHANA has a range of products that guarantee the routine monitoring and quality control of the LTSF sterilization processes.- The monitoring of packagings, non sterile and sterile packs and/or containers is carried out by means of step controls that allow the organization of the healthcare material. - The routine quality control of each sterilization cycle with controls designed to evaluate the correct physico-chemical parameters of the process and the assessment of the microbial lethality of the devices. - The added bonus of the MATACHANA chemical and biological controls proceeds from the certification by internationally highly prestigious laboratories that guarantee the quality and reliability of the products regards to the correct evaluation of the LTSF sterilization processes.

Monitoring

Ref. 85694.5LTSF adhesive tape. The adhesive tape contains a Type 1 chemical process control that allows the marking of packages and/or containers to be submitted to LTSF sterilization process and enables to distinguish between processed and non-processed material according to EN ISO 11140 Part 1.

Ref. 85272LTSF self-adhesive dots together with a Type 1 process chemical control allow the marking of packages and/or containers to be submitted to LTSF sterilization process and enables to distinguish between processed and non-processed material according to EN ISO 11140 Part 1.

Ref. 85431.5 Load control device + chemical strips for LTSF, Type 2 indicators, specific for testing the diffusion and penetration of the sterilizing agent into instruments with long lumens and narrow pipe cavities (eg. endoscopes), according to EN ISO 11140 Part 1 and EN 867 Part 5.

PROCESS STEP CONTROLS. ORGANIZING HEALTHCARE MATERIAL WITHIN ITS REPROCESSING UNITS (RUMED)

PROCESS QUALITY CONTROLS. EVALUATION OF PHYSICAL-CHEMICAL PARAMETERS AND MICROBIOLOGICAL LETHALITY OF LTSF STERILIZATION PROCESSES

Ref. 85274 Internal controls to verify the variables of the LTSF sterilization process, in packages and wrapped material, according to EN ISO 11140 Part 1.

INTERNAL CHEMICAL INDICATORS, TYPE 4 Determine the success of sterilization of non-complex material surfaces.

CONTROLS FOR THE ANALYSIS OF PCD PENETRABILITY CAPACITY, TYPE 2

Ref. 85270 (48h) Self-contained biological indicators whose spores have been produced for LTSF sterilization processes, in accordance with EN ISO 11138 Standard Part 1 and 5.Incubation temperature: 57 °CIncubation time: 48 hoursSpecific sporulation processes to make spores resistant to formaldehyde.

SELF-CONTAINED BIOLOGICAL INDICATORS

INCUBATOR FOR SELF-CONTAINED BIOLOGICAL INDICATORS

Ref. 85208Incubator for self-contained biological indicators to verify the growth of G. stearothermophilus at 57 ºC. CE conformity marking certificate.

Establish the penetrability effectiveness of the LTSF process.

Guarantees the safety of the load release after the process

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Sterilizing solution and other accessories Sterilizing solutionBox with 3 bags of sterilizing solution, with a volume of 2.7 litres per unit. To be used only for the MATACHANA sterilizer 130LF. The sterilizing solution is contained in plastic bags of highly resistant LDPE*, totally recyclable.

Compatible with the packaging traditionally used in RUMED for steam sterilizer:

- Paper-plastic bags and rolls (the most recommendable).- Sterilization paper: crepe, non-woven paper, PEP, SMS, etc.

Compatible with metal containers, provided that they are fitted with a filter.

Compatible with plastic containers.

Wrapping material compatibility with LTSF process

MATACHANA sterilizing solution is supplied in a LDPE* disposable bag of 2.7 litres capacity and only 2 % formaldehyde concentration. Once the bag is placed properly in the consumption components compartment, its content is emptied automatically into the corresponding container, without the user’s additional handling.

* Low Density Polyethylene; recyclable material with great resistance and flexibility properties.

Solution bag

Automatic solution supply system

As standard equipment, the sterilizer is provided with an automatic device which ensures safe supply of the sterilant solution from the bag to a storage tank located inside the sterilizer, preventing any leakage or spillage of solution to the ground or towards the user. By simply inserting the sterilizing solution bag in the compartment on the front of the sterilizer, the system automatically detects the position of the bag and when properly placed, blocks the bag while activating the puncture operation.

Additionally, a number of illuminated icons on the backlit front of the sterilizer report on the status of the sterilizing bag as well as its correct perforation. This way, the user can quickly find out if the bag has been correctly placed, and its content properly poured into the inner tank, for future dosing during the execution of a sterilization cycle.

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Innovation is the way forward Since the company's foundation more than 50 years ago, our mission has been to provide the best service, bringing our knowledge and field experience to our customers to facilitate their daily work, allowing them to be efficient in the production whereas keeping rigorously the quality.

MATACHANA has a worldwide presence, with offices based in Spain, France, Germany, Italy, United States, Argentina, Malaysia and China, or through its distributors in over 110 countries.

In MATACHANA we are aware that Training and Service contribute decisively to achieve customer satisfaction. For this reason, we have always invested in the development of these two areas of activity, which enables a direct contact with customers and help us to develop together a continuous improvement process. Technical Engineering SupportAn assistance provided by engineers, highly skilled expert technicians and support staff, all committed to ensure the proper equipment operation and condition.

MIEC, training centerAs we feel seriously committed and liable for achieving the optimum operation from the MATACHANA equipment, we invest in the training of future users, proposing a service of educational courses to all our customers on a regular basis and in the 5 continents.

Environmentally friendlyThe devices are designed and manufactured using the latest technologies on the market to achieve the best results in terms of energy savings and reduction in water consumption. Our Production Center located in Castelldefels (Barcelona) complies with the ISO 14001 Environmental Management System and ISO 50001 Energy Management.

QualityThe MATACHANA devices are developed, manufactured and tested within a strict quality control according to the international Standards ISO 9001 and EN ISO 13485 for the quality management of medical devices.

Matachana ChinaSuite 1125, 11 Floor, Garden SquareNo. 968 West Beijing Road, Shanghai200041, P. R. of ChinaTel. (+86) 21 52037677www.matachana.com

Matachana Asia Pacific 7-1, Tower 3, Avenue 3, The Horizon, Bangsar South, No. 8 Jalan Kerinchi 59200, Kuala Lumpur, MalaysiaTel. (+60) 3 22423250 www.matachana.com

Matachana ArgentinaLincol 2572 · Villa Maipu,(B1650KED) San Martín Buenos Aires · ArgentinaTel. (+54) 11 48390880www.matachana.com

Matachana USA300 North Pottstown Pike, Suite 110Exton, PA, 19341, USA Tel. (+1) 484 8732763www.matachana.com

Matachana ItalyVia Berlino, 6 loc. Zingonia24040 Verdellino (BG) · ItalyTel. (+39) 035 883122www.matachana.it

Matachana FranceEuroparc · 5 allée des Saules94043 Créteil Cedex · FranceTel. (+33) 1 41941780www.matachana.fr

Matachana GermanyAn der Trave 14 23923 Selmsdorf · Germany Tel. (+49) 451 280720www.matachana.de

Matachana HeadquartersAlmogàvers, 17408018 Barcelona · SpainTel. (+34) 93 4868700www.matachana.com

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