Theoretical Principles and Practical Skills of Aseptic Manipulations Curriculum: Pharmacy Target Audience: Pharmacists and Pharmacy Technicians Authors: Philip Trapskin, PharmD Rebecca Reagan, RPh Kimberley Hite, MS, PharmD John Armitstead, MS, RPh, FASHP Service Area: Pharmacy Services Phone: 859 257-8414 Email: khite2@email.uky.edu Date Developed Or Revised: April, 2005

Barrier isolator technology Menu Definitions Background Laminar Air Flow Hoods Barrier isolator technology Aseptic Technique Exit

Definitions Enteral Parenteral Aseptic Technique Of or relating to the intestines (e.g. by mouth, orally, per tube) Parenteral Introduced other than by way of the intestines (e.g. intravenous, intramuscular, subcutaneous) Aseptic Technique The technique for manipulations of compounded sterile products and parenteral preparations that prevents contamination

Definitions (cont.) Contamination – any effect or action that has a negative impact on a product's integrity making it unfit for use Chemical composition pH Sterility (e.g. microorganism contamination) Pyrogenicity Biological or therapeutic potency Physical appearance Particulate matter (e.g. dust, glass or precipitation)

Why do we give medications parenterally? Background Why do we give medications parenterally? Patients who are not able to take medications by mouth Need for rapid action of the medication as in emergency situations Medication not available in a suitable dosage form to be given by mouth Patients with difficulty absorbing medications

Sources of product contamination Background (cont.) Sources of product contamination People (most common) Touch contamination Generation of particulates from shedding cells or hair Supply air Heating Ventilation and Air Conditioning (HVAC) Infiltration Particles from adjacent spaces (e.g. anteroom) Internal generation Walls, floors, ceilings, packaging, equipment

Importance of Aseptic Technique Background (cont.) Importance of Aseptic Technique Parenteral administration bypasses the skin and gastrointestinal tract, the bodies natural barriers to infection Giving a patient a contaminated product can cause serious adverse effects including DEATH Parenteral medications account for >40% of all medications administered in institutional practice

Laminar Air Flow Hoods The 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 air The hood workspace is used to prevent the contamination of compounded sterile products and parenteral preparations The space between the HEPA filter and sterile product being prepared is referred to as the critical work surface HEPA filter - High Efficiency Particulate Air filter removes 99.97% of all air particles 0.3mm or larger

Laminar Air Flow Hoods (cont.) HEPA Filter in Frame

Laminar Air Flow Hoods (cont.) Horizontal Flow (Laminar Flow Hood) Air blows towards worker Used for non-chemotherapy preparations Vertical Flow (Biological Safety Cabinet or Chemotherapy Hood) Air blows from top down to maintain sterility and protect the worker Used to make chemotherapy

Laminar Air Flow Hoods (cont.) Horizontal Laminar Air Flow Hood Horizontal Laminar Air Flow Hood Hepa Filter Filtered Air Room Air Prefilter

Laminar Air Flow Hoods (cont.) Vertical Laminar Flow Hood

Correct placement of items in a laminar flow hood

Incorrect placement of items in a laminar flow hood Wrong!!

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 inches inside hood

Laminar Air Flow Hoods (cont.) A laminar flow hood should be left operating continuously If hood is turned off it must run for 30 minutes to reestablish laminar air flow and then be cleaned prior to use Before use, all interior working surfaces of the laminar flow hood should be cleaned from back to front away from the HEPA filter Back to Front Away from HEPA filter

Laminar Air Flow Hoods (cont.)

Laminar Air Flow Hoods (cont.)

Laminar Air Flow Hoods (cont.) At UKCMC the procedure for cleaning a hood should occur in the following order: Obtain 4X4 gauze Clean the hood with sterile water for irrigation (bar, sides, base) Obtain new 4x4 gauze Clean 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

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 screen Nothing should be permitted to come in contact with the HEPA filter NO cleaning solution NO aspirate from syringes NO glass from ampules NO fluids, even if sterile DO NOT touch HEPA filter

Laminar Air Flow Hoods (cont.) Only products essential to product preparation should be placed in the laminar flow hood to minimize the potential for contamination No Paper, Pens, Calculators or Labels in the Hood

Laminar Air Flow Hoods (cont.) Eating, drinking, and smoking is always prohibited Talking or coughing should be directed away from the hood to minimize air flow turbulence A mask covering mouth and nose must be worn while working in the hood The use of a laminar flow hood alone without the observance of aseptic technique, cannot insure product sterility

Barrier Isolator Technology

Barrier Isolator Technology (cont.) Closed system: workers manipulate compounding through gloved ports Personnel are the primary source of contamination of compounded preparations Barrier Isolator removes personnel from environment where parenteral products are prepared Good aseptic technique is still required Barrier isolators are exempted from placement restrictions of materials within the workspace

Barrier Isolator Technology (cont.) Barrier Isolator Workstations consist of: Physical Structure Internal Environment Transfer and Interaction Technology Monitoring Systems

Barrier Isolator Technology (cont.) Physical Structure Hard shell or soft shell Hard shell (plastic, Plexiglas, stainless steel) Soft shell (soft plastic film) Internal Environment Less airflow required to achieve ISO 5 (Class 100) conditions Entering and exiting air is to be HEPA filtered Isolators for cytotoxic preparations should capture vapor Positive pressure maintained for non-chemotherapy products Negative pressure is maintained for chemotherapy products

Barrier Isolator Technology (cont.) Transfer and interaction technology Transfer Rapid transfer ports Air-lock Laminar-airflow interfaces Interaction Glove ports (most common) Half-suits Monitoring Systems Gauges to monitor positive pressure environment Surface sampling for contamination

Aseptic Technique Aseptic technique is the technique for manipulations of compounded sterile products and parenteral preparations that prevents contamination Aseptic technique requires specific manipulations for: Syringes Needles Vials Ampules Removal of packaging Assembling of sterile products Hand placement

Aseptic Technique - Syringes NEVER TOUCH Tip or Plunger

Aseptic Technique - Syringes 1.5ml measured

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 syringe DO NOT use syringes whose gradations are greater than twice the volume being measured To maintain sterility, neither the syringe tip or plunger should be touched

Aseptic Technique - Needles Hub Where the needle attaches to the syringe tip and allows the fluid in the syringe barrel Bevel The 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

Aseptic Technique - Needles Coring The development of a core or hole in the rubber of a vial To prevent coring insert needle as shown Insert the bevel tip first, then pressing downward and toward the bevel so the bevel tip and heel enter at the same point

Aseptic Technique - Needles Needle size is determined by two numbers Gauge Length The larger the gauge number the finer the diameter of the needle’s bore 27 gauge needle finer than 13 gauge needle Common needle sizes at UK include 16G 1&1/2 inch 18G 1&1/2 inch 20G 1 inch Needle length is measured in inches Never touch any part of the needle Open needle package within hood to maintain sterility

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 workspace Needles and syringes must be properly disposed in a sharps container located near the hood to prevent injury to others Never dispose of needles or syringes in regular trash

Aseptic Technique - Vials and Ampules

Aseptic Technique - Vials and Ampules To prevent contamination Swab rubber closure with 70% alcohol using firm strokes in the SAME direction To prevent core formation Insert needle to penetrate the rubber closure at same point with both tip and heel of bevel To prevent vacuum formation Inject an equal amount of air for the volume of fluid to be removed Reconstituting drug powder Remove an equal amount of air for the volume of diluent added

Aseptic Technique - Vials and Ampules

Aseptic Technique - Vials and Ampules To break ampule Clean ampule neck with alcohol swab Leave swab in place Grasp ampule neck with thumb and index finger Use quick, firm, snapping motion away from body towards side wall of hood DO NOT BREAK TOWARD HEPA FILTER

Aseptic Technique - Vials and Ampules To withdraw medication from ampule Tilt ampule Place needle bevel in corner space near opening Pull back syringe plunger Do NOT use a filter needle to remove ampule contents To avoid glass contamination of ampule solution Use 5 micron filter needle to filter glass as solution is pushed out of the syringe A filter needle can only be used in one direction, otherwise glass particles originally filtered are reintroduced For UK consistency always use the filter needle as the second needle

Aseptic Technique - Vials and Ampules 1 2 3 4

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.

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.

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.

If in doubt, throw it out Summary Aseptic technique is the manipulation of sterile products to prevent contamination Giving a patient a contaminated product can cause serious adverse effects including DEATH Discard any potentially contaminated product and inform the pharmacist that product was discarded If in doubt, throw it out

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