Preparing Sterile Formulation

Preparing Sterile Preparing Sterile FormulationsFormulations

OutlineOutline

• Parenterals: Sterile Formulation

• LVP Solutions• SVP Solutions• Special Solutions• Laminar Flow Hoods• Biological Safety Cabinets• Clean Rooms• Aseptic Techniques in

Hoods & Cabinets

Working with vialsWorking with vials Working with ampoulesWorking with ampoules Syringes & needlesSyringes & needles FiltersFilters Administration devicesAdministration devices Parenteral Parenteral

incompatibilitiesincompatibilities Quality assurance & Quality assurance &

Infection ControlInfection Control Units of measurementUnits of measurement

Parenterals: Sterile Parenterals: Sterile FormulationsFormulations

The IV route of administration is The IV route of administration is used: used:

To reach appropriate drug serum To reach appropriate drug serum levels. levels.

To guarantee compliance.To guarantee compliance. For drugs with unreliable For drugs with unreliable gastrointestinal (GI) absorption. gastrointestinal (GI) absorption.

For the patient who can have nothing For the patient who can have nothing by mouth .by mouth .

For the patient who is unconscious For the patient who is unconscious or uncooperative.or uncooperative.

For rapid correction of fluid or For rapid correction of fluid or electrolytes.electrolytes.

IV SolutionsIV Solutions The vehicles most commonly used for IV The vehicles most commonly used for IV infusions are: infusions are: Dextrose in water.Dextrose in water. NS solution.NS solution. Dextrose in saline solution.Dextrose in saline solution.

The two main types of IV solutions The two main types of IV solutions are: are: Small-volume parenterals (SVPs)Small-volume parenterals (SVPs) of of 50 or Less than 100 Ml.50 or Less than 100 Ml.

Large-volume parenterals (LVPs) Large-volume parenterals (LVPs) of of more than 100 mL.more than 100 mL.

Characteristics of IV Characteristics of IV PreparationsPreparations

Intravenous (IV) preparations are Intravenous (IV) preparations are either: either: Solutions (in which ingredients are Solutions (in which ingredients are dissolved). dissolved).

Suspensions (in which ingredients Suspensions (in which ingredients are suspended).are suspended).

Most parenteral preparations are made Most parenteral preparations are made of ingredients in a of ingredients in a sterile water . sterile water .

Some parenteral preparations may be Some parenteral preparations may be oleaginous (oily). oleaginous (oily).


An An isotonic solutionisotonic solution is a solution in is a solution in which body cells can be bathed without which body cells can be bathed without a net flow of water across a a net flow of water across a semipermeable membrane.semipermeable membrane. 0.9% normal saline (NS).0.9% normal saline (NS).

A A hyper tonic solution has more number has more number of particles than the blood cells of particles than the blood cells themselves.themselves. 50% dextrose or 3% sodium chloride. 50% dextrose or 3% sodium chloride.

A solution of less than normal tonicity A solution of less than normal tonicity is is hypo tonic,hypo tonic, which has fewer numbers which has fewer numbers of particles than blood cells. of particles than blood cells. 0.45% NS.0.45% NS.


TheThe pH valuepH value is the degree of acidity or is the degree of acidity or alkalinity of a solution. alkalinity of a solution. Acidic solution: pH of less than 7.Acidic solution: pH of less than 7. Alkaline solution: pH value more than Alkaline solution: pH value more than 7.7.

Human blood plasma has a pH of 7.4.Human blood plasma has a pH of 7.4. Slightly alkaline.Slightly alkaline. Parenteral IV solutions should have a Parenteral IV solutions should have a pH that is neutral (near 7).pH that is neutral (near 7).

Intravenous PreparationsIntravenous Preparations Most parenterals are introduced Most parenterals are introduced directlydirectly into the bloodstream into the bloodstream

Must be Must be free of air bubbles free of air bubbles or or particulate matter.particulate matter.

Have many characteristics including Have many characteristics including solubility, osmolality, and pH.solubility, osmolality, and pH.

The solution must be stable for its The solution must be stable for its intended use.intended use.

Must be Must be PYROGENPYROGEN free. free. Chemicals that are produced by Chemicals that are produced by microorganisms.microorganisms.

Soluble in water and Soluble in water and NOT NOT removed removed by sterilizing or filtering the by sterilizing or filtering the solutions.solutions.

Intravenous FormulationsIntravenous Formulations

Osmotic PressureOsmotic Pressure The characteristics of a solution The characteristics of a solution determined by the number of determined by the number of disserved particles in it. disserved particles in it.

OsmolalityOsmolality A unit of measure of osmotic A unit of measure of osmotic pressure.pressure.

Blood has 300 mOsmol per liter.Blood has 300 mOsmol per liter. Both NS and D5W solutions have a Both NS and D5W solutions have a similar osmolarity.similar osmolarity.

Methods of InjectionMethods of Injection The The bolus,bolus, or or injectioninjection, is one of the , is one of the most common routes of IV most common routes of IV administration.administration.

The injection is performed using a The injection is performed using a syringe.syringe. Prepackaged in the form of filled, Prepackaged in the form of filled, disposable plastic syringes.disposable plastic syringes.

Injectable drug must be taken up Injectable drug must be taken up into the syringe from a single or into the syringe from a single or multi-dose glass or plastic vial, or multi-dose glass or plastic vial, or from a glass ampule.from a glass ampule.

Sometimes the solid drug in the vial Sometimes the solid drug in the vial has to be reconstituted by addition of has to be reconstituted by addition of a liquid before use.a liquid before use.

Methods of InjectionMethods of Injection IV infusions IV infusions deliver:deliver:

Large amounts of liquid into the Large amounts of liquid into the bloodstream over prolonged periods bloodstream over prolonged periods of time.of time.

IV infusion is used to deliver: IV infusion is used to deliver:

Large Volume SolutionsLarge Volume Solutions Packaged in containers holding Packaged in containers holding 100 ml or 100 ml or more.more.

The most common sizes:The most common sizes: 100, 250, 500, and 1,000 ml.100, 250, 500, and 1,000 ml.

Common LVP solutions:Common LVP solutions: Sodium Chloride, Dextrose Solution, Sodium Chloride, Dextrose Solution, Ringers Solution.Ringers Solution.

Containers:Containers: Plastic bags:Plastic bags:Weight less, less storage Weight less, less storage space, disposable.space, disposable.

Glass bottle: Glass bottle: (with or without air vent (with or without air vent tube).tube).

Good for drugs that interact with Good for drugs that interact with plastic bags.plastic bags.

E.g. Nitroglycerine, amiodarone.E.g. Nitroglycerine, amiodarone.

Large Volume Large Volume SolutionsSolutions

PortsPorts- Administration - Administration portport- Medication - Medication portport

Regulatory RequirementsRegulatory Requirements Both USP and FDA have regulations.Both USP and FDA have regulations. Chapter of USP <797>: Chapter of USP <797>:

Pharmaceutical Compounding Sterile Pharmaceutical Compounding Sterile Preparations established Preparations established requirements for the aseptic requirements for the aseptic preparing of sterile dosage forms. preparing of sterile dosage forms.

Intent is Intent is to prevent infection and to prevent infection and contamination.contamination.

Provides guidelines for development Provides guidelines for development of policies and procedures for the of policies and procedures for the safe preparation of sterile safe preparation of sterile preparation.preparation.

Common LVP SolutionsCommon LVP Solutions Four common solutions used either as Four common solutions used either as LVP solutions or as the primary part LVP solutions or as the primary part of an admixture solution are:of an admixture solution are: sodium chloride solutionsodium chloride solution dextrose solutiondextrose solution Ringer's solutionRinger's solution Lactated Ringer's solutionLactated Ringer's solution

Various combinations of different Various combinations of different strengths of sodium chloride and strengths of sodium chloride and dextrose solutions are also dextrose solutions are also available.available. E.g., 5% dextrose and 0.45% sodium E.g., 5% dextrose and 0.45% sodium chloride, or 5% dextrose and chloride, or 5% dextrose and 0.225% sodium chloride.0.225% sodium chloride.

Small Volume SolutionsSmall Volume Solutions SVP solutions SVP solutions are 100 ml or less.are 100 ml or less.

• Primarily used for delivering Primarily used for delivering medications.medications.

Ampules, Prefilled syringes, Single Ampules, Prefilled syringes, Single or Multi dose vials.or Multi dose vials.

AdditiveAdditive: a drug that is added to a : a drug that is added to a Paternal solution.Paternal solution.

Admixture: Admixture: the resulting solution the resulting solution when a drug is added to a Parenteral when a drug is added to a Parenteral solution.solution.

Small Volume SolutionsSmall Volume Solutions Lypholizied Lypholizied – freeze dried powders– freeze dried powders Diluent Diluent – solvent used to – solvent used to reconstitute a powdered drugreconstitute a powdered drug

Ready-to-mix systemsReady-to-mix systems - Add-Vantage®, - Add-Vantage®, Add-a-Vial®, Mini-Bag Plus®Add-a-Vial®, Mini-Bag Plus®

Total Parenteral Nutrition (TPN) Total Parenteral Nutrition (TPN) SolutionsSolutions

Provide Provide nutritional support nutritional support to to patients who are unable to take in patients who are unable to take in adequate nutrients through their adequate nutrients through their digestive tract.digestive tract.

Contains Contains macro and micro nutrients.macro and micro nutrients. MacronutrientsMacronutrients: dextrose, fat, and : dextrose, fat, and protein.protein.

Micronutrients: Micronutrients: electrolytes, electrolytes, vitamins, and trace elements.vitamins, and trace elements.

Lipid emulsion Lipid emulsion may be added.may be added. Available in 2 or 3 Litter sizes.Available in 2 or 3 Litter sizes. Administered via the Administered via the subclavian vein subclavian vein over 8-24 hours.over 8-24 hours.

Dialysis SolutionsDialysis Solutions DialysisDialysis - the passage of small - the passage of small particles through membranes.particles through membranes.

Renal dialysis Renal dialysis – artificial kidney– artificial kidney Peritoneal dialysis Peritoneal dialysis – a solution – a solution placed in and emptied from the placed in and emptied from the peritoneal cavity to remove toxic peritoneal cavity to remove toxic substance from the body.substance from the body.

Irrigation SolutionsIrrigation Solutions Administered directly into the venous Administered directly into the venous system but are subject to the same system but are subject to the same stringent controls as IV fluids .stringent controls as IV fluids .

Container size, usually larger than 1 Container size, usually larger than 1 liter.liter.

Surgical irrigation Surgical irrigation solution used.solution used. To bath and moisten body tissue, To bath and moisten body tissue, dressing, or dressing, or

wash instruments.wash instruments. Urological irrigation solution Urological irrigation solution usedused

To maintain tissue integrity or To maintain tissue integrity or remove blood to maintain a clear remove blood to maintain a clear file of vision.file of vision.

E.g. Glycine 1.5%, Sorbitol 3%E.g. Glycine 1.5%, Sorbitol 3%

Laminar Flow HoodsLaminar Flow Hoods Carefully enclosed work area designed Carefully enclosed work area designed to prevent contamination. to prevent contamination.

Air is drawn through a high Air is drawn through a high efficiency particulate air efficiency particulate air (HEPA)(HEPA) filter that removes particles larger filter that removes particles larger than 0.5 microns.than 0.5 microns.

The purified air then flows over the The purified air then flows over the work surface at a uniform velocity work surface at a uniform velocity (i.e. (i.e. laminar flow) laminar flow) of 80-100 of 80-100 ft./min. ft./min.

The cabinet is usually made of The cabinet is usually made of stainless steel with no gaps or stainless steel with no gaps or joints where spores might collect.joints where spores might collect.

The surfaces of the The surfaces of the hood's work area are CLEAN, but hood's work area are CLEAN, but

NOT NOT sterile.sterile.

It is necessary to use techniques It is necessary to use techniques which maintain the sterility of all which maintain the sterility of all sterile items called sterile items called aseptic aseptic techniques.techniques.

Laminar Flow HoodLaminar Flow Hood

HEPA filter

intake filter

laminar flow from above

blower air inPT 8-2:2

air out

Vertical Flow Vertical Flow HoodHood

Horizontal Flow HoodHorizontal Flow Hood Hoods exist in bothHoods exist in both horizontal and horizontal and vertical vertical configurations. configurations.

HorizontalHorizontal Blows air toward the operator.Blows air toward the operator.

Used for preparing Used for preparing IVs, TPNs, compounding, eye solutions, IVs, TPNs, compounding, eye solutions, and any drug that is not hazardous.and any drug that is not hazardous.

Vertical Flow Hood & Biological Vertical Flow Hood & Biological Safety HoodSafety Hood

Protects personnel and the environmentProtects personnel and the environment Air is passed into a Air is passed into a HEPAHEPA filter and filter and directed down toward the work surface directed down toward the work surface and is pulled through vents at the and is pulled through vents at the front, back and sides of the hood.front, back and sides of the hood.

Used for Used for chemotherapy and mixing live chemotherapy and mixing live viruses.viruses.

Two typesTwo types Class 2, Type A Class 2, Type A Class 2, Type BClass 2, Type B

Cleaning Hoods or CabinetsCleaning Hoods or Cabinets Turn the hood or cabinet on and Turn the hood or cabinet on and let it let it operate for at least 30 minutes operate for at least 30 minutes before use. before use.

Clean the inside of the hood with a suitable Clean the inside of the hood with a suitable disinfectant. disinfectant.

First clean the metal pole used to hang the First clean the metal pole used to hang the containers.containers.

Then the sides of the hood are cleaned using Then the sides of the hood are cleaned using up and down motions moving from the back of up and down motions moving from the back of the hood toward the front.the hood toward the front.

Then the bottom of the hood is cleaned using Then the bottom of the hood is cleaned using side-to-side motions moving from the back of side-to-side motions moving from the back of the hood toward the front.the hood toward the front.

If using a spray bottle to dispense the If using a spray bottle to dispense the disinfectant, be sure not to spray the HEPA disinfectant, be sure not to spray the HEPA filter.filter.

Clean RoomsClean Rooms Clean rooms are rooms that have a Clean rooms are rooms that have a controlledcontrolled level of contamination level of contamination and are used to prepare sterile and are used to prepare sterile preparations.preparations.

Need to follow the regulations under Need to follow the regulations under USP/NF <797>.USP/NF <797>.

Only Only designated personnel designated personnel should should enter the space.enter the space.

ISO Class 7 environment ISO Class 7 environment means any means any air flow unit used in the clean room air flow unit used in the clean room is capable of producing an is capable of producing an environment containing no more than environment containing no more than 10,000 air born particles of a size 10,000 air born particles of a size 0.5 microns or larger per cubic food 0.5 microns or larger per cubic food of air.of air.

Aseptic TechniquesAseptic Techniques Aseptic Techniques are the sum total Aseptic Techniques are the sum total of methods and manipulations required of methods and manipulations required to minimize the contamination of to minimize the contamination of sterile products. sterile products.

Contaminants are microorganisms Contaminants are microorganisms and/or particulate material.and/or particulate material.

Working in a laminar flow hood Working in a laminar flow hood DOES DOES NOTNOT, by itself, guarantee a sterile , by itself, guarantee a sterile formulation.formulation.

IV Preparation IV Preparation Preparing IV’s Preparing IV’s should always be done should always be done under the supervision of a licensed under the supervision of a licensed pharmacist.pharmacist.

Medication that is prepared by the Medication that is prepared by the technician must always be reviewed technician must always be reviewed and approved by the pharmacist. and approved by the pharmacist.

Preparing IVsPreparing IVs Pharmacists and technicians prepare Pharmacists and technicians prepare drugs and IV solutions in a form drugs and IV solutions in a form ready to be administered to a ready to be administered to a patient.patient.

IV push IV push (i.e., bolus) and IV (i.e., bolus) and IV infusion dose forms should be infusion dose forms should be prepared in laminar airflow hoods prepared in laminar airflow hoods using using aseptic techniques .aseptic techniques . Products used during the Products used during the preparation must always be preparation must always be sterilesterile and handled in such a and handled in such a manner as to prevent manner as to prevent contamination.contamination.

IV Preparation GuidelinesIV Preparation Guidelines Begin all IV preparations by Begin all IV preparations by washing washing your hands your hands thoroughly. thoroughly.

All jewelry All jewelry should be removed from the should be removed from the hands and wrists before scrubbing and hands and wrists before scrubbing and while making a sterile product. while making a sterile product.

Wear Wear glovesgloves during all procedures. during all procedures. Laminar airflow hoods are normally Laminar airflow hoods are normally kept running.kept running.

Eating, drinking, talking, or coughing Eating, drinking, talking, or coughing is prohibited in the laminar airflow is prohibited in the laminar airflow hood. hood.

Working in the laminar flow hood Working in the laminar flow hood should should be free from interruptions.be free from interruptions.

IV Preparation GuidelinesIV Preparation Guidelines Before making the product, thoroughly clean all interior working surfaces.

Gather all the necessary materials for the operation and make sure they are: Not expired. Free from particulate matter such as dust.

Check for leaks by squeezing plastic solution containers.

Only essential objects and materials necessary for product preparation should be placed in the airflow hood.

IV Preparation GuidelinesIV Preparation Guidelines Work in the center of the work area Work in the center of the work area within the laminar airflow hood.within the laminar airflow hood. At least At least six inchessix inches inside the inside the edge of the hood edge of the hood

Make sure nothing obstructs the Make sure nothing obstructs the flow of air from the high-flow of air from the high-efficiency particulate air (HEPA) efficiency particulate air (HEPA) filter over the preparation area.filter over the preparation area.

Nothing should pass behind a Nothing should pass behind a sterile object and the HEPA filter sterile object and the HEPA filter in a horizontal airflow hood or in a horizontal airflow hood or above a sterile object in a above a sterile object in a vertical airflow hood.vertical airflow hood.

IV Preparation GuidelinesIV Preparation Guidelines Follow proper procedure for handling Follow proper procedure for handling sterile devices and medication sterile devices and medication containers.containers.

Remember that Remember that the plunger the plunger and the and the tip of the syringe tip of the syringe are sterile and are sterile and must not be touched.must not be touched.

For greatest accuracy, use the For greatest accuracy, use the smallest syringe that can hold the smallest syringe that can hold the desired amount of solution.desired amount of solution.

Complete a Complete a quality check quality check of the of the product for container integrity and product for container integrity and leaks, solution cloudiness, leaks, solution cloudiness, particulates, color of solution, and particulates, color of solution, and proper preparation of product.proper preparation of product.

Aseptic TechniqueAseptic Technique

Put on non-shedding coats, gowns, or Put on non-shedding coats, gowns, or coveralls (hospital scrubs), head coveralls (hospital scrubs), head and facial hair covers, face masks, and facial hair covers, face masks, and shoe covers. Note that it is and shoe covers. Note that it is important to follow the sequence of important to follow the sequence of items indicated in this step.items indicated in this step.

Clean the laminar flow hood Clean the laminar flow hood with with isopropyl alcohol. isopropyl alcohol. The alcohol must The alcohol must remain in contact with the surface remain in contact with the surface for 30 seconds prior to compounding for 30 seconds prior to compounding any sterile product.any sterile product.

Working with VialsWorking with Vials Vials are closed systems.Vials are closed systems.

The amount of air introduced The amount of air introduced should be equal to the volume should be equal to the volume of fluid removed .of fluid removed .

An exception to this guideline An exception to this guideline is the withdrawal of cytotoxic is the withdrawal of cytotoxic drugs from vialsdrugs from vials

There are two types:There are two types: The drug already in the The drug already in the solution.solution.

A powder that must be dissolved A powder that must be dissolved in a dilute to make a solution.in a dilute to make a solution.

Powders are reconstituted by Powders are reconstituted by introducing a diluent (e.g., introducing a diluent (e.g., sterile water for injection).sterile water for injection).

CoringCoring Coring is when a needle damages the Coring is when a needle damages the rubber closure of a Parenteral rubber closure of a Parenteral container causing fragments of the container causing fragments of the closure to fall into the container closure to fall into the container and contaminate its contents.and contaminate its contents.

To prevent coring:To prevent coring: Place the vial on a flat surface Place the vial on a flat surface and position the needle point on and position the needle point on the surface of the rubber.the surface of the rubber.

Put downward pressure on the Put downward pressure on the needle while gradually bringing needle while gradually bringing the needle to an upright position.the needle to an upright position.

Vial Containing SolutionsVial Containing Solutions1. Choose the smallest gauge needle 1. Choose the smallest gauge needle

appropriate for the task. appropriate for the task. 2. Attach the needle to the syringe.2. Attach the needle to the syringe.3. Draw into the syringe an amount of air 3. Draw into the syringe an amount of air

equal to the amount of drug to be drawn equal to the amount of drug to be drawn from the vial.from the vial.

4. Swab or spray the top of the vial with 4. Swab or spray the top of the vial with alcohol before entering the laminar flow alcohol before entering the laminar flow hood; allow the alcohol to dry. hood; allow the alcohol to dry.

5. Puncture the rubber top of the vial 5. Puncture the rubber top of the vial with the needle bevel up. with the needle bevel up.

6. Then bring the syringe and needle 6. Then bring the syringe and needle straight up, penetrate the stopper, and straight up, penetrate the stopper, and depress the plunger of the syringe, depress the plunger of the syringe, emptying the air into the vial.emptying the air into the vial.

Vial Containing SolutionsVial Containing Solutions7.7. Invert the vial with the Invert the vial with the attached syringe.attached syringe.

8. Draw up from the vial the amount 8. Draw up from the vial the amount of liquid required.of liquid required.

9. Withdraw the needle from the 9. Withdraw the needle from the vial. In the case of a multi-dose vial. In the case of a multi-dose vial, the rubber cap will close, vial, the rubber cap will close, sealing the contents of the vial.sealing the contents of the vial.

10. Remove and properly dispose of 10. Remove and properly dispose of the needle, and cap the syringe. A the needle, and cap the syringe. A new needle will be attached at the new needle will be attached at the time of injection into a patient.time of injection into a patient.

Vials Contain Lyophilized PowderVials Contain Lyophilized Powder

Determine the correct volume of Determine the correct volume of diluents.diluents.

Transfer the diluent into the vial.Transfer the diluent into the vial. Remove the volume of air into the Remove the volume of air into the syringe once the diluents is added.syringe once the diluents is added.

Swirl the vial until the drug is Swirl the vial until the drug is dissolved.dissolved.

Using a new needle and syringe, Using a new needle and syringe, transfer the reconstituted solution transfer the reconstituted solution to the final container.to the final container.

Ampules Ampules

An An ampule ampule is a single-dose-only drug is a single-dose-only drug container.container.

The glass ampule offers a challenge The glass ampule offers a challenge because one must first break the top because one must first break the top off the ampule before withdrawing the off the ampule before withdrawing the medication.medication.

Ampules Ampules

Gently tap the top Gently tap the top of the ampule to of the ampule to bring the medication to the lower bring the medication to the lower portion of the ampule.portion of the ampule.

Clean the neck Clean the neck with an alcohol with an alcohol swab, then grasp the ampule between swab, then grasp the ampule between your thumb and index finger at the your thumb and index finger at the neck with the swab still in place.neck with the swab still in place.

Forcefully snap Forcefully snap the neck away from the neck away from you.you.

AmpulesAmpules To withdraw To withdraw from an ampule, tilt the from an ampule, tilt the ampule, place the needle bevel of a ampule, place the needle bevel of a filter or the tip of a filter straw filter or the tip of a filter straw in the corner near the opening, and in the corner near the opening, and withdraw the medication. withdraw the medication.

Use a needle equipped with a filter Use a needle equipped with a filter for for filtering out filtering out any tiny glass any tiny glass particles, fibers, or paint chips particles, fibers, or paint chips that may have fallen into the that may have fallen into the ampule.ampule.

AmpulesAmpules Before injecting the contents of a Before injecting the contents of a syringe into an IV, the syringe into an IV, the needle must needle must be changed be changed to avoid introducing to avoid introducing glass or particles into the glass or particles into the admixture.admixture.

A standard needle could be used to A standard needle could be used to withdraw the drug from the ampule; withdraw the drug from the ampule; it is then replaced with a filter it is then replaced with a filter device before the drug is pushed out device before the drug is pushed out of the syringe..of the syringe..

Filter needles are for one Filter needles are for one directional use only.directional use only.

Equipment Used in IV PreparationEquipment Used in IV Preparation Pharmacies use Pharmacies use plastic disposable plastic disposable products products to:to: Save time and money. Save time and money. Provide the patient with an inexpensive Provide the patient with an inexpensive sterile product. sterile product.

Often the entire system sent out to the Often the entire system sent out to the patient is composed of plastic.patient is composed of plastic. Thin, flexible plastic catheters are Thin, flexible plastic catheters are replacing metal shafts that deliver the replacing metal shafts that deliver the medication into the vein.medication into the vein.

In many cases the only durable, non-In many cases the only durable, non-disposable product used to deliver IV disposable product used to deliver IV medication is the IV pump or controllermedication is the IV pump or controller..

Syringes and NeedlesSyringes and Needles Syringes are used for IV push and Syringes are used for IV push and in the preparation of infusions; in the preparation of infusions; they are made of glass or plastic. they are made of glass or plastic.

Glass syringes Glass syringes are more expensive.are more expensive. Use limited to medications that Use limited to medications that are absorbed by plastic are absorbed by plastic

Plastic syringesPlastic syringes Less expensive.Less expensive. Disposable. Disposable. Arrive from the manufacturer Arrive from the manufacturer sterile.sterile.

Syringes & NeedlesSyringes & Needles Basic parts of a syringeBasic parts of a syringe

Barrel is a tube that is open at Barrel is a tube that is open at one end and tapers into a hollow one end and tapers into a hollow tip at the other end.tip at the other end.

Plunger is a piston-type rod with Plunger is a piston-type rod with a slightly cone-shaped stopper a slightly cone-shaped stopper that presses the barrel.that presses the barrel.

Tip provides the point of Tip provides the point of attachment for a needle.attachment for a needle.

Common types: Slip-Tip®, Luer-Lock®, Common types: Slip-Tip®, Luer-Lock®, and Eccentric tips®.and Eccentric tips®.

Syringes and NeedlesSyringes and Needles

Needles are made of stainless steel Needles are made of stainless steel or aluminum. or aluminum. Needle lengths range from 3/8 of an Needle lengths range from 3/8 of an inch to 6 inches. inch to 6 inches.

Needles come in gauges ranging from Needles come in gauges ranging from 30 to 13 (higher the gauge, smaller 30 to 13 (higher the gauge, smaller the lumen). the lumen).

After use, needles must be discarded After use, needles must be discarded in a designated sharps container.in a designated sharps container.

Syringes and NeedlesSyringes and Needles

Various types & have Various types & have several characteristicsseveral characteristics Graduation marksGraduation marks SizesSizes GaugesGauges

SyringesSyringes

Needle

TipBarrel

Plunger

Different size needles

PT 8-1:3

hubshaft

bevel

Filters Filters

Filters are devices used to remove Filters are devices used to remove contaminants such as glass, paint, contaminants such as glass, paint, fibers, and rubber cores.fibers, and rubber cores. Will not remove virus particles or Will not remove virus particles or toxins.toxins.

Occasionally become clogged, thus Occasionally become clogged, thus slowing expected flow rates.slowing expected flow rates.

FiltersFilters Depth filters Depth filters Inside the hub of a filtered needle Inside the hub of a filtered needle - 5 micron- 5 micron

Membrane filters.Membrane filters. FFilter solution when being expelled ilter solution when being expelled from the syringe. from the syringe. 0.22 micron.0.22 micron.

Final filterFinal filter Used immediately before it enters Used immediately before it enters the patient’s vein.the patient’s vein.

FiltersFilters

Membrane filter

Filter needleUsing a membrane filter

PT 8-1:4

IV SetsIV Sets

An An IV administration setIV administration set Sterile, pyrogen-free disposable.Sterile, pyrogen-free disposable. Device used to deliver IV fluids to Device used to deliver IV fluids to patients. patients.

The set mayThe set may Be sterilized before use by means of Be sterilized before use by means of radiation or ethylene oxide.radiation or ethylene oxide.

Come in sterile packaging and a sealed Come in sterile packaging and a sealed plastic wrapplastic wrap

Sets do not carry expiration dates. Sets do not carry expiration dates. Sets carry the legend Sets carry the legend

““Federal law restricts this device to Federal law restricts this device to sell by or on the order of a physician.”sell by or on the order of a physician.”

IV SetsIV Sets IV sets are sterile and IV sets are sterile and nonpyrogenic.nonpyrogenic.

Each unit is supplied in packaging Each unit is supplied in packaging that ensures the maintenance of that ensures the maintenance of sterility.sterility.

Most of the length of the tubing is Most of the length of the tubing is molded from a pliablemolded from a pliable polyvinyl polyvinyl chloride (PVC). chloride (PVC).

PVC sets should not be used for: PVC sets should not be used for: NitroglycerinNitroglycerin, which is absorbed , which is absorbed by the tubing.by the tubing.

IV fat emulsionsIV fat emulsions, which may leach , which may leach out of the tubing.out of the tubing.

IV SetsIV Sets The The length of sets length of sets varies from 6-inch varies from 6-inch extensions up to 110- to 120-inch extensions up to 110- to 120-inch sets used in surgery.sets used in surgery. The priming of tubing depends on The priming of tubing depends on the length of the setthe length of the set

Standard sets have a lumen diameter Standard sets have a lumen diameter of 0.28 cm.of 0.28 cm. Varying sizes of the lumen diameter Varying sizes of the lumen diameter achieves different flow rates.achieves different flow rates.

Regulation of flow rates is Regulation of flow rates is critical in neonates and infants.critical in neonates and infants.

IV SetsIV Sets A A spikespike to pierce the rubber to pierce the rubber stopper or port on the IV stopper or port on the IV container.container.

A A drip chamber drip chamber for trapping for trapping air and adjusting flow rate.air and adjusting flow rate.

A A control clamp control clamp for for adjusting flow rate or adjusting flow rate or shutting down the flow.shutting down the flow.

Flexible tubing to convey Flexible tubing to convey the fluid.the fluid.

IV SetsIV Sets A needle adapter for attaching a A needle adapter for attaching a needle or a catheter.needle or a catheter.

A A catheter, or tubecatheter, or tube, may be implanted , may be implanted into the patient and fixed with tape into the patient and fixed with tape to avoid having to repuncture the to avoid having to repuncture the patient each time an infusion is patient each time an infusion is given.given.

Most IV sets contain Most IV sets contain a Y-site,a Y-site, or or injection port and used for adding injection port and used for adding medication to the IV. medication to the IV.

Some IV sets also contain Some IV sets also contain resealable resealable in-line filtersin-line filters to protect the to protect the patient against particulates, patient against particulates, including bacteria and emboli.including bacteria and emboli.

IV SetsIV Sets Clamps allow for adjusting the rate Clamps allow for adjusting the rate of flow and for shutting down the of flow and for shutting down the flow.flow.

Clamps may be located at any position Clamps may be located at any position along the flexible tubing.along the flexible tubing.

Usually a clamp moves freely, Usually a clamp moves freely, allowing its location to be changed allowing its location to be changed to one that is convenient for the to one that is convenient for the health professional administering the health professional administering the medication.medication.

Pumps and ControllersPumps and Controllers Fluids and drugs are often delivered Fluids and drugs are often delivered to catheters by some form of device, to catheters by some form of device, including electronic devices, to including electronic devices, to control the infusion rate.control the infusion rate.

The first system to deliver a drug IV The first system to deliver a drug IV was the was the syringe system. syringe system.

The syringe system is very nurse The syringe system is very nurse labor-intensive and pharmacy labor-labor-intensive and pharmacy labor-intensive.intensive.

Pumps and ControllersPumps and Controllers The The Buretrol or Soluset Buretrol or Soluset were in use were in use before infusion pumps and replaced before infusion pumps and replaced the syringe system and has a built-in the syringe system and has a built-in graduated cylinder. graduated cylinder. Fluid is run into the cylinder.Fluid is run into the cylinder. Nurses can add a drug in the top of Nurses can add a drug in the top of the cylinder injection port for the cylinder injection port for dilution and mixing before it is dilution and mixing before it is infused.infused.

Safer than the syringe system because Safer than the syringe system because the drug is being diluted in the the drug is being diluted in the cylinder and it can be infused over a cylinder and it can be infused over a long period of time.long period of time.

Pumps and ControllersPumps and Controllers Infusion pumps are preferred by Infusion pumps are preferred by both nurses and physicians. both nurses and physicians. Produce a positive pressure of Produce a positive pressure of 10 to 25 psi.10 to 25 psi.

More accurate than controllers.More accurate than controllers. Have fewer flow interruptions.Have fewer flow interruptions.

Infusion pumps control the flow of Infusion pumps control the flow of IV medications.IV medications.

Maximum flow is 999 mL/hr.Maximum flow is 999 mL/hr. Provides a higher rate of Provides a higher rate of infusion.infusion.

Higher pressure increases Higher pressure increases possibility of infiltration.possibility of infiltration.

Pumps and ControllersPumps and Controllers A patient-controlled analgesia (PCA) A patient-controlled analgesia (PCA) device is a type of medication device is a type of medication delivery that uses a parenteral route delivery that uses a parenteral route and allows the patient to administer and allows the patient to administer analgesics by pressing a button.analgesics by pressing a button. Controls the medication so the Controls the medication so the patient cannot overdose or give the patient cannot overdose or give the medication too soon after the medication too soon after the previous dose.previous dose.

Often, after surgery or severe Often, after surgery or severe injuries, a physician will order a injuries, a physician will order a PCA for the patient for 24 to 72 PCA for the patient for 24 to 72 hours.hours.

CathetersCatheters IV administration for fluids and drug IV administration for fluids and drug therapy can be accomplished through therapy can be accomplished through needle-like devices called catheters. needle-like devices called catheters.

CathetersCatheters are devices inserted into are devices inserted into veins for direct access to the blood veins for direct access to the blood vascular system and are used in two vascular system and are used in two primary ways: primary ways: Peripheral venous cathetersPeripheral venous catheters are are inserted into a vein close to the inserted into a vein close to the surface of the skin. surface of the skin.

Central venous catheters Central venous catheters are inserted are inserted deeper in the body.deeper in the body.

IV SolutionsIV Solutions A A piggyback piggyback isis a small-volume parenteral a small-volume parenteral admixture that is attached to an existing admixture that is attached to an existing IV line .IV line .

The piggyback solution is infused into the The piggyback solution is infused into the tubing of the running IV.tubing of the running IV. Usually over a short time, from 30 Usually over a short time, from 30 minutes to 1 hour.minutes to 1 hour.

Heparin Locks Heparin Locks – is a short piece of tubing – is a short piece of tubing attached to a needle or IV catheters used attached to a needle or IV catheters used to prevent blood from clotting in the tube. to prevent blood from clotting in the tube.

Preparing a Label for an IV Preparing a Label for an IV AdmixtureAdmixture

Labels for IV admixtures should bear the Labels for IV admixtures should bear the following information:following information: Patient’s name and identification Patient’s name and identification numbernumber

Room numberRoom number Fluid and amountFluid and amount Drug name and strength (if Drug name and strength (if appropriate)appropriate)

Infusion periodInfusion period Flow rate (e.g., 100 mL/hr or infuse Flow rate (e.g., 100 mL/hr or infuse over 30 min)over 30 min)

Expiration date and time Expiration date and time Additional information as required by Additional information as required by the institution or by state or federal the institution or by state or federal guidelines.guidelines.

Parenteral IncompatibilitiesParenteral Incompatibilities NOTNOT all drugs are compatible with all drugs are compatible with each othereach other

IncompatibilitiesIncompatibilities When two or more drugs react that When two or more drugs react that are incompatible with each other, are incompatible with each other, one drug can cause the degradation one drug can cause the degradation of the other drug.of the other drug.

Characteristics Characteristics of of incompatibilities:incompatibilities: Color changeColor change Hazy appearanceHazy appearance PrecipitationsPrecipitations

Parenteral IncompatibilitiesParenteral Incompatibilities NOTNOT all incompatibilities are dangerous, all incompatibilities are dangerous, some are normal.some are normal.

Color change Color change Imipenem-cilastatin or dobutamine may Imipenem-cilastatin or dobutamine may show some color change but NOT a sign show some color change but NOT a sign of incompatibility.of incompatibility.

Hazy Appearance Hazy Appearance When ceftazidime is reconstituted, When ceftazidime is reconstituted, carbon dioxide gas is released.carbon dioxide gas is released.

Precipitation Precipitation The precipitate that forms when The precipitate that forms when paclitaxel is refrigerated dissolves at paclitaxel is refrigerated dissolves at room temperature.room temperature.

Incompatibilities – Contribution Incompatibilities – Contribution FactorsFactors

Light Light Amphotericin B, cisplatin, Amphotericin B, cisplatin, metronidazole must be protected from metronidazole must be protected from light.light.

Temperature Temperature Cefazolin stable at room Temp for 24 Cefazolin stable at room Temp for 24 hrs but under refrigeration for 96 hrs.hrs but under refrigeration for 96 hrs.

Dilution Dilution Up to 15 mEq of Calcium can be added to Up to 15 mEq of Calcium can be added to a liter of solution containing 30mEq of a liter of solution containing 30mEq of PO4.PO4.

Buffer capacity, pH, and TimeBuffer capacity, pH, and Time

Incompatibilities – Contribution Incompatibilities – Contribution FactorsFactors

FiltersFilters Inline filter cause 90% reduction in Inline filter cause 90% reduction in nitroglycerin.nitroglycerin.

Solutions Solutions Ampotericin B is not compatible in NS.Ampotericin B is not compatible in NS.

Chemical ComplexationChemical Complexation Ca reduces tetracycline activity.Ca reduces tetracycline activity. Needle or filter containing aluminum Needle or filter containing aluminum should not be used with Cisplatin-should not be used with Cisplatin-AQ.AQ.

Plastics Plastics Albumin should be used in glass bottle Albumin should be used in glass bottle because it binds to PVC plastics.because it binds to PVC plastics.

Quality Assurance (AQ) & Infection Quality Assurance (AQ) & Infection ControlControl

USP/NF <797> requires that every USP/NF <797> requires that every compounding facility has to have a QA compounding facility has to have a QA program.program.

Major componentsMajor components Semi-annual testing and certification.Semi-annual testing and certification. Routine monitoring of environmental Routine monitoring of environmental airborne.airborne.

Routine monitoring of operating Routine monitoring of operating temperature.temperature.

Maintaining continuous positive Maintaining continuous positive pressured.pressured.

Continuous HEPA filtered air.Continuous HEPA filtered air.

Hazardous Waste RegulationsHazardous Waste Regulations The Resources Conservation and The Resources Conservation and Recovery Act (RCRA) regulates Recovery Act (RCRA) regulates handling hazardous waste from its handling hazardous waste from its generation to disposal.generation to disposal.

Hazardous waste must be collected Hazardous waste must be collected and stored according to specific EPA and stored according to specific EPA and DOT requirements.and DOT requirements.

Hazardous materials classificationHazardous materials classification P-list waste includes epinephrine, P-list waste includes epinephrine, NTG, and physostigmine.NTG, and physostigmine.

U-list wastes includes toxic, U-list wastes includes toxic, flammable, corrosive, or reactive flammable, corrosive, or reactive and cyclophosphamide. and cyclophosphamide.

Sharps DisposalSharps Disposal

SharpsSharps An object that might puncture or cut An object that might puncture or cut the skin of anyone who handles them.the skin of anyone who handles them.

Needles, jagged glass, or metal Needles, jagged glass, or metal objects.objects.

Sharp containers Sharp containers should be easily indentified, leak should be easily indentified, leak proof, puncture proof, and be able to proof, puncture proof, and be able to be sealed permanently.be sealed permanently.

Hazardous Waste Regulations Hazardous Waste Regulations • Protective Clothing Protective Clothing

• A disposable, lint-free, A disposable, lint-free, nonabsorbent, closed-front gown nonabsorbent, closed-front gown with cuffed sleeves should be with cuffed sleeves should be worn. worn.

• Hair and shoe covers should be Hair and shoe covers should be worn to reduce the potential for worn to reduce the potential for particulate contamination.particulate contamination.

• Eye protectionEye protection• MaskMask• Use of latex gloves when Use of latex gloves when disposing of damaged packages.disposing of damaged packages.

Units of Measurement

Molarity A mole is the number of grams numerically equal to the molecular weight of the drug.

Osmoles Equal to the molecular weight of the drug divided by the number of ions formed when a drug dissolves in solution.

Osmole = molecular weight # of ions


Equivalents Expression for an amount of drug is the equivalent weight (Eq).

Equilvalent weight = molecular weight valence


Percentage weight per volume Refers to the drug’s weight per 100 ml if the drug is a solid

The drug’s volume per 100 ml if the drug is a liquid.

Solid: % = weight (gm) 100 ml

Liquid: % = volume (ml) 100 ml

Terms to RememberTerms to Remember

1. Horizontal flow 1. Horizontal flow hoodhood

2. Hub2. Hub3. Hypertonic3. Hypertonic4. Hypotonic4. Hypotonic5. Ions5. Ions6. Irrigation 6. Irrigation solutionsolution

7. Isotonic7. Isotonic8. Laminar flow8. Laminar flow9. Lumen9. Lumen10. Lyophilized10. Lyophilized11. Membrane filter11. Membrane filter

12. Molecular weight12. Molecular weight13. Omsosis13. Omsosis14. Osmotic pressure 14. Osmotic pressure 15. Peritoneal dialysis 15. Peritoneal dialysis solutionsolution

16. Piggybacks16. Piggybacks17. Pyrogens17. Pyrogens18. Ready-to-mix18. Ready-to-mix19. Shaft19. Shaft20. Sharps20. Sharps21. Slip-tip®, luer-lok®, 21. Slip-tip®, luer-lok®, eccentric, oraleccentric, oral

22. Total nutrient admixture 22. Total nutrient admixture (TNA) solution(TNA) solution

Terms to RememberTerms to Remember

23. Total parenteral23. Total parenteral nutrition (TPN) solutionnutrition (TPN) solution

24. Additive24. Additive25. Admixture25. Admixture26. Ampules26. Ampules27. Anhydrous27. Anhydrous28. Aseptic 28. Aseptic techniquestechniques

29. Bevel29. Bevel30. Compounded 30. Compounded sterilesterile

31. Preparation (CSP)31. Preparation (CSP)32. Coring32. Coring33. Depth filter33. Depth filter

34. Dialysis34. Dialysis35. Diluent35. Diluent36. Equivalent weight36. Equivalent weight37. Final filter37. Final filter38. Flashball38. Flashball38. Flow rate38. Flow rate40. Gauge40. Gauge41. HEPA filter41. HEPA filter42. Heparin lock42. Heparin lock

Preparing Sterile Formulation

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