= ASEPTIC TECHNIQUE, C1 Procedure - prevent contamination of drugs, packaging, equipment or supplies with microorganisms during their preparation Ensures sterility 1D Sterility ~ freedom from bacteria and other mi Causes of contamination: O Personnel O Environment OD Equipment Personnel 1D First component of good aseptic technique is proper personal attire D Clean garments Particulate free . Clean scrub suits or gowns Hair covers & shoe covers, surgical masks & gloves Touch is the most common means of contaminating a pharmacy-compounded sterile preparation 1 Hands must be washed properly - using the correct technique Proper hand washing depends on running water, a cleansing agent, and friction Hand Washing Remove all rings and watches. 2. Stand close to, but not touching, the sink. 3. Tum on the faucet using a foot pedal or a dry sterile towel. Discard the towel. 4. Wet hand, wrists, and forearms under running warm water, and apply liquid antibacterial soap. 5. For 15 to 30 seconds, serub the palm of one hand with the fingers of the other hand, then repeat for the opposite hand. 6. Use a brush and scrub the fingernails and backs and palms of the hands, and then scrub the wrists and forearms. 7. Hold the hands in a downward position and rinse well. 8. Dry the hands and then the wrists gently with a sterile towel. 9. Use a dry, sterile towel to turn off the faucet if it is not operated by a foot pedal. 1 When decontaminating hands with an alcohol-based hand rub, apply produet to palm of one hand and rub hands together; covering all surfaces of hands, and fingers, until hands are dry. D Multiple-use cloth towels of the hanging or roll type are not recommended for use in health-care settings. 1D Hand washing is sometimes incorrectly omitted when gloves are worn, the assumption being that they provide enough hand protection. Gloving 1. Pick up the euff of the right glove with your left hand. 2. Slide your right hand into the glove until you have a snug fit over the thumb joint and knuckles. 3. Your bare left hand should only touch the folded cuff - the rest of the glove remains sterile. 4. Slide your right fingertips into the folded euff of the left glove. 5. Pullout the glove and fit your left hand into it. 6. Unfold the cuffs down over your gown sleeves. Make sure your gloved fingertips do not touch your bare forearms or wrists. Environment 1D Class 100 environment contains no more that 100 airborne particles of a size 0.5 micron and larger, per cubie foot of air D Class 10001 Class 10.000 Clean Room 1 an area that is specially constructed and maintained to reduce the probability of environmental contamination of sterile products ‘must meet the high standards of purity and cleanliness for parenteral compounding products must follow USP 797, which is stringent set of rules and regulations regarding aseptic preparations surfaces of all floors, wall, eeilings, cabinets, shelving, and work surfaces in the buffer room should bet 11 soft and smooth - free from crevices oF eracks special attention must be given to air being drawn into clean rooms by the following systems: DD Heating Ventilation DD Air Conditioning personnel entering the aseptic area should enter only through an airlock traffic flow into the room should be minimized and in- and-out movement rigidly restricted during a filling oOo ooo oo procedure 1 should have an anteroom that is used for non-aseptic activities related to the clean room such as: 0 Gowning 1D Handling Stock Order Processing LAFW is considered critical equipment for good aseptic technique. 1 Constant flow of HEPA filtered air physically swoops the work arca and prevents the entry of contaminated air, 1 The space between the HEPA filter and sterile product is roferred to as the critical work surface. CO. HEPA filter - High Efficiency Particulate Air filter removes 99.97% of all air particles 2 0.3mm Horizontal Flow (Laminar Flow Hood) 1 Air blows towards worker 11 Used for non-chemotherapy preparations C2 Vertical Flow (Biological Safety Cabinet or Chemotherapy Hood) 1 Air blows from top down to maintain sterility and protect the worker 1 Used to prepare chemotherapy drugs General Principles for Proper Operation 1. All manipulations should be performed at least 6 inches within the LAFW. 2. A LAFW should operate continuously. 3. Before use, all interior working surfaces of the LAFW should be cleaned. D_ 10% isopropyl alcohol / disinfecting agent G clean, lint-free non-shedding cloth D1 cleaning should be from hack to front 4, Nothing should touch the HEPA filter. 5. A LAFW should be positioned away from excess traffic, doors, air vents, fans, and air currents capable of introducing contaminants. 6. Hand and wrist jewelry should not be worn. 7. Actions such as talking and coughing should be directed away from the « motion should be avoided to minimize airflow turbulence. 8. Only objects that are essential to compounding sterile preparations should be placed in the LAFW. 9, LAFWs should be tested and certified by qualified porsonnel every 6 months, whenever the LAFW is moved, and if filter damage is suspected. 10. Food and drink should not be permitted within the aseptic preparation area. al area, and any unnecessary1D used for IV push and in the preparation of infusions Dade of glass or plastic BD Glass syring more expensive © use limited to medications that are absorbed by plastic © Plastic syringes Mare less expensive @ are disposable come from the manufacturer sterile Parts of a Syringe “Tip - Barrel = Plunger piston - Top collar - Plunger - Final edge of plunger piston -Flatend OF Critical areas of a syringe include the tip, the plunger, and the plunger piston. These areas should not be touched. D_Non-Critical areas of a syringe include the barrel, collar, and lip. These areas may be touched. Needles are made of stainless steel or aluminum D_ needle lengths range from 3/8 of an inch to 6 inches needles come in gauges ranging from 30 to 13 (higher the gauge, smaller the lumen) 1 After use, needles must be discarded in a designated sharps container. Parts of a Needle = Point = Bevel + Shaft - Hub Vials Closed systems the amount of air introduced should be equal to the volume of fluid removed an exception to this guidel e withdrawal of cytotoxic drugs from vials C1 Powders are reconstituted by introducing a diluent (e.g, sterile water for injection) “With the exception of eytotoxie drugs, inject an equal amount of air into the vial with the syringe and needle bofore withdrawing the medication. Withdrawing Liquid from a Vial 1. Choose the smallest gauge needle appropriate for the task, and avoid coring the rubber top of the vial and thus introducing particulates into the liquid within it. 2. Attach the needle to the syringe. 3. Draw into the syringe an amount of air equal to the amount of drug to be drawn from the vial. 4. Swab or spray the top of the vial with alcohol before entering the laminar flow hood; allow the aleohol to dry. Puncture the rubber top of the vial with the needle bevel up. Then bring the syringe and needle straight up, penetrate the stopper, and depress the plunger of the syringe, emptying the air into the vial. * The swabbing is effective in two ways: = The aleohol acts as a disinfecting agent. - The physical act of swabbing in one direction remove particles from the vial diaphragm.Invert the vial with the attached syringe. Draw up from the vial the amount of liquid required. Withdraw the needle from the vial. In the case of a multidose vial, the rubber cap will close, sealing the contents of the vial. 8, Remove and properly dispose of the needle, and cap the syringe. A new needle will be attached at the time of injection into a patient. nee Ampule 1 a single-dose-only drug contai D glass ampules © offers another challenge because one must first break the top off the ampule before withdrawing the medication a Opening an Ampule 1. Gently tap the top of the ampule to bring the medication to the lower portion of the ampule. Swirl the ampule in an upright position. Invert the ampule, then quickly swing to upright position. 2, Clean the neck with an aleohol swab. The head of the ampule should be held between the thumb and index finger of one hand, and the body should be held with the thumb and index finger of the other hand. 3. Forcefully snap the neck away from you. Withdrawing Liquid from an Ampule 1. Tilt the ampule. 2. Place the needle bevel in the corner near the opening. 3. Withdraw the medication. Administering Medication C1 Before injecting the contents of a syringe into an IV line or hub, the needle must be changed to avoid introducing glass or particles into the admixture.