3 Definitions Enteral Parenteral Aseptic Technique Of or relating to the intestines(e.g. by mouth, orally, per tube)ParenteralIntroduced other than by way of the intestines(e.g. intravenous, intramuscular, subcutaneous)Aseptic TechniqueThe technique for manipulations of compounded sterile products and parenteral preparations that prevents contamination
4 Definitions (cont.)Contamination – any effect or action that has a negative impact on a product's integrity making it unfit for useChemical compositionpHSterility (e.g. microorganism contamination)PyrogenicityBiological or therapeutic potencyPhysical appearanceParticulate matter (e.g. dust, glass or precipitation)
5 Why do we give medications parenterally? BackgroundWhy do we give medications parenterally?Patients who are not able to take medications by mouthNeed for rapid action of the medication as in emergency situationsMedication not available in a suitable dosage form to be given by mouthPatients with difficulty absorbing medications
6 Sources of product contamination Background (cont.)Sources of product contaminationPeople (most common)Touch contaminationGeneration of particulates from shedding cells or hairSupply airHeating Ventilation and Air Conditioning (HVAC)InfiltrationParticles from adjacent spaces (e.g. anteroom)Internal generationWalls, floors, ceilings, packaging, equipment
7 Importance of Aseptic Technique Background (cont.)Importance of Aseptic TechniqueParenteral administration bypasses the skin and gastrointestinal tract, the bodies natural barriers to infectionGiving a patient a contaminated product can cause serious adverse effects including DEATHParenteral medications account for >40% of all medications administered in institutional practice
8 Laminar Air Flow HoodsThe underlying principle of a laminar air flow hood is that a constant flow of HEPA filtered air at a rate of approximately 90 linear feet per minute physically sweeps the work area and prevents the entry of contaminated airThe hood workspace is used to prevent the contamination of compounded sterile products and parenteral preparationsThe space between the HEPA filter and sterile product being prepared is referred to as the critical work surfaceHEPA filter - High Efficiency Particulate Air filter removes 99.97% of all air particles 0.3mm or larger
9 Laminar Air Flow Hoods (cont.) HEPA Filter in Frame
10 Laminar Air Flow Hoods (cont.) Horizontal Flow (Laminar Flow Hood)Air blows towards workerUsed for non-chemotherapy preparationsVertical Flow (Biological Safety Cabinet or Chemotherapy Hood)Air blows from top down to maintain sterility and protect the workerUsed to make chemotherapy
11 Laminar Air Flow Hoods (cont.) Horizontal Laminar Air Flow HoodHorizontal Laminar Air Flow HoodHepa FilterFiltered AirRoom AirPrefilter
12 Laminar Air Flow Hoods (cont.) Vertical Laminar Flow Hood
13 Correct placement of items in a laminar flow hood
14 Incorrect placement of items in a laminar flow hood Wrong!!
15 Laminar Air Flow Hoods (cont.) All aseptic manipulations should be performed at least SIX inches within the hood to prevent the possibility of contamination from room air entering the hood.6 inchesinside hood
16 Laminar Air Flow Hoods (cont.) A laminar flow hood should be left operating continuouslyIf hood is turned off it must run for 30 minutes to reestablish laminar air flow and then be cleaned prior to useBefore use, all interior working surfaces of the laminar flow hood should be cleaned from back to front away from the HEPA filterBack to FrontAway from HEPA filter
19 Laminar Air Flow Hoods (cont.) At UKCMC the procedure for cleaning a hood should occur in the following order:Obtain 4X4 gauzeClean the hood with sterile water for irrigation (bar, sides, base)Obtain new 4x4 gauzeClean the hood with 70% isopropyl alcohol (bar, sides, base)Hoods should be cleaned at the beginning of each shift and as needed throughout the shift
20 Laminar Air Flow Hoods (cont.) The HEPA filter is located in the fragile mesh between thin metal strips at the back of the hood behind the HEPA filter screenNothing should be permitted to come in contact with the HEPA filterNO cleaning solutionNO aspirate from syringesNO glass from ampulesNO fluids, even if sterileDO NOT touch HEPA filter
21 Laminar Air Flow Hoods (cont.) Only products essential to product preparation should be placed in the laminar flow hood to minimize the potential for contaminationNo Paper, Pens, Calculators or Labels in the Hood
22 Laminar Air Flow Hoods (cont.) Eating, drinking, and smoking is always prohibitedTalking or coughing should be directed away from the hood to minimize air flow turbulenceA mask covering mouth and nose must be worn while working in the hoodThe use of a laminar flow hood alone without the observance of aseptic technique, cannot insure product sterility
24 Barrier Isolator Technology (cont.) Closed system: workers manipulate compounding through gloved portsPersonnel are the primary source of contamination of compounded preparationsBarrier Isolator removes personnel from environment where parenteral products are preparedGood aseptic technique is still requiredBarrier isolators are exempted from placement restrictions of materials within the workspace
25 Barrier Isolator Technology (cont.) Barrier Isolator Workstations consist of:Physical StructureInternal EnvironmentTransfer and Interaction TechnologyMonitoring Systems
26 Barrier Isolator Technology (cont.) Physical StructureHard shell or soft shellHard shell (plastic, Plexiglas, stainless steel)Soft shell (soft plastic film)Internal EnvironmentLess airflow required to achieve ISO 5 (Class 100) conditionsEntering and exiting air is to be HEPA filteredIsolators for cytotoxic preparations should capture vaporPositive pressure maintained for non-chemotherapy productsNegative pressure is maintained for chemotherapy products
27 Barrier Isolator Technology (cont.) Transfer and interaction technologyTransferRapid transfer portsAir-lockLaminar-airflow interfacesInteractionGlove ports (most common)Half-suitsMonitoring SystemsGauges to monitor positive pressure environmentSurface sampling for contamination
28 Aseptic TechniqueAseptic technique is the technique for manipulations of compounded sterile products and parenteral preparations that prevents contaminationAseptic technique requires specific manipulations for:SyringesNeedlesVialsAmpulesRemoval of packagingAssembling of sterile productsHand placement
29 Aseptic Technique - Syringes NEVER TOUCHTip or Plunger
31 Aseptic Technique - Syringes Syringes are available in sizes ranging from 0.5 to 60 milliliters (ml)Graduation marks on syringes represent different increments depending on size of syringeDO NOT use syringes whose gradations are greater than twice the volume being measuredTo maintain sterility, neither the syringe tip or plunger should be touched
32 Aseptic Technique - Needles HubWhere the needle attaches to the syringe tip and allows the fluid in the syringe barrelBevelThe tip of needle is slanted to a point and the slanted part of the needle is the bevel. The bevel allows for smooth insertions through stoppers and ports with minimal coring
33 Aseptic Technique - Needles CoringThe development of a core or hole in the rubber of a vialTo prevent coring insert needle as shownInsert the bevel tip first, then pressing downward and toward the bevel so the bevel tip and heel enter at the same point
34 Aseptic Technique - Needles Needle size is determined by two numbersGaugeLengthThe larger the gauge number the finer the diameter of the needle’s bore27 gauge needle finer than 13 gauge needleCommon needle sizes at UK include16G 1&1/2 inch18G 1&1/2 inch20G 1 inchNeedle length is measured in inchesNever touch any part of the needleOpen needle package within hood to maintain sterility
35 Aseptic Technique - Needles and Syringes It is important that when using needles and syringes in product preparation that they not be removed from the hood workspaceNeedles and syringes must be properly disposed in a sharps container located near the hood to prevent injury to othersNever dispose of needles or syringes in regular trash
37 Aseptic Technique - Vials and Ampules To prevent contaminationSwab rubber closure with 70% alcohol using firm strokes in the SAME directionTo prevent core formationInsert needle to penetrate the rubber closure at same point with both tip and heel of bevelTo prevent vacuum formationInject an equal amount of air for the volume of fluid to be removedReconstituting drug powderRemove an equal amount of air for the volume of diluent added
39 Aseptic Technique - Vials and Ampules To break ampuleClean ampule neck with alcohol swabLeave swab in placeGrasp ampule neck with thumb and index fingerUse quick, firm, snapping motion away from body towards side wall of hoodDO NOT BREAK TOWARD HEPA FILTER
40 Aseptic Technique - Vials and Ampules To withdraw medication from ampuleTilt ampulePlace needle bevel in corner space near openingPull back syringe plungerDo NOT use a filter needle to remove ampule contentsTo avoid glass contamination of ampule solutionUse 5 micron filter needle to filter glass as solution is pushed out of the syringeA filter needle can only be used in one direction, otherwise glass particles originally filtered are reintroducedFor UK consistency always use the filter needle as the second needle
42 Aseptic Technique - Removing Packaging Any sterile component or supply (e.g., syringes, needles, and ampules) should only be opened and/or removed from their packaging within the laminar-flow workspace.When opening the wrapper on a needle, it should be peeled open.Tearing paper introduces paper particles into the hood which could lead to product contamination.
43 Aseptic Technique - Assembling Great care must be exercised to prevent any touch contamination of critical edges or component surfaces.The syringe tip and plunger and all parts of the needle are critical surfaces.
44 Aseptic Technique - Hand Placement It is important that hand placement during any aseptic manipulation is such that laminar airflow is not interrupted around any of the critical sterile fluid pathways.Great care should be taken to avoid contact with the syringe plunger, especially during multiple manipulations using the same syringe. Since the plunger enters the barrel of the syringe during repeated uses, contamination can be accidentally introduced into the barrel.
45 If in doubt, throw it out Summary Aseptic technique is the manipulation of sterile products to prevent contaminationGiving a patient a contaminated product can cause serious adverse effects including DEATHDiscard any potentially contaminated product and inform the pharmacist that product was discardedIf in doubt, throw it out
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