UKCMC Aseptic Technique Practical Exam

Practical Exam and Media-Fill Test Procedure and Assessment Form Name: Proctor: Date: Satisfactory Unsatisfactory Comments

1 Garb 1.1 Prior to entering the buffer room, personnel should remove outer lab jackets, makeup and jewelry. All jewelry must be removed from hands, fingers and wrists. 1.2 Personnel should properly put on clean, non-shedding uniform components in this order: gown, shoe covers, hair covers 1.3 Hair bonnets should be worn. Surgical caps are not to be used. All hair must be contained within the bonnet. Two bonnets may be necessary to contain long hair. Facial hair must be covered to enter the buffer area (mask for mustache, beard cover 1.4 for beards). in the ante room may be done with soap and water using the sink. Hand washing Personnel should wet hands first with water, apply an amount of product as specified by the manufacturer to hands, and rub hands together vigorously for at least 15 seconds (e.g. sing Happy Birthday song) covering all surfaces of hands, fingers and arm up to elbows. 1.5 A new scrub brush should be used to clean thoroughly under fingernails and between fingers. 1.6 Rinse hands with water and dry thoroughly with a disposable, non-shedding towel. Use towel to turn off faucet or use foot pump. 1.7 Protective gloves should be donned as the final piece of garb and gloved hands should be washed using waterless alcohol based cleanser or isopropyl alcohol 70% within the buffer room. Gloves should be allowed to air dry prior to use. 1.8 Face masks should be donned just before personnel begin activities in the IV hood to avoid airborne contamination from coughing, sneezing, and talking. The mask should be worn to cover the nose and mouth. If using a vertical flow LAFW with transparent shield between face and sterile product or if using an isolator, the facial mask is optional however head and facial hair must be covered.

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UKCMC Aseptic Technique Practical Exam

2 Cleaning and Sanitation of Direct and Contiguous Compounding Areas (Instruct compounder to assume it is the beginning of their shift) 2.1 Uses 4x4 gauze AND Sterile Water for Irrigation first, then 70% isopropyl alcohol to clean compounding area. Order of cleaning should be bar, sides of hood, base of hood. 2.2 Cleans back to front avoiding contact and contamination of HEPA filter

2.3 Able to identify work surfaces to be disinfected at the beginning of each shift

3 Global Aseptic Technique Assessment 3.1 How long must a laminar flow workbench run prior to use? (For at least 30 minutes) 3.2 What types of products must NOT be prepared in the same hood that is used for the preparation of other sterile products? (Cytotoxic and hazardous products) 3.3 Demonstrates understanding of air flow in hood, maintains flow of clean air over objects in hood, does not interrupt air flow, works well within the hood (at least 6) 3.4 Keeps all non-essential items (e.g. paper, labels) outside of hood 3.5 Does not contaminate the HEPA filters with liquid, glass ampule particles or other means during the compounding process. 3.6 Demonstrates proper technique for swabbing , entering and withdrawing fluid from vials, ampules and bags. Does not touch or contaminate components that must remain sterile. 3.7 Minimizes positive pressure in vials during reconstitution or withdrawal of medications by injecting an equal volume of air. Does not aspirate at any time. 3.8 Inspects final admixture for incompatibilities, cores, precipitate and particulate matter. 3.9 Demonstrates knowledge of labeling multi-use vials after initial entry or reconstitution. (including date opened or beyond use date, concentration, and initials)

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UKCMC Aseptic Technique Practical Exam

4 Ampule - Minibag Transfer Technique Assessment (Growth Media Product 1)

4.1 Selection of needed materials - minibag, ampule, 3 or 5 ml syringe, regular needle, filter needle, alcohol swab(s) 4.2 Swabs minibag transfer port with alcohol at least once (if multiple swabs all swabs should be in same direction) 4.3 Breaking ampule - Cleans ampule neck with alcohol swab; leaves swab in place; grasps ampule neck with thumb and index finger; uses quick, firm snapping motion away from body towards side of the hood; does not break towards HEPA filter 4.4 Withdraw 2ml from ampule- Obtains appropriate size syringe and 18G 1"needle; tilts ampule; places needle bevel in corner space near opening; pulls back syringe plunger to 2ml (Never touches syringe tip/plunger, or any part of the needle) 4.5 Transfer the 2ml from ampule to minibag- removes current needle; attaches filter needle; swabs minibag prior to transfering 2ml to minibag

5 Vial to Minibag Multiple Transfers with Syringe and Needle (Growth Media Product 2) 5.1 Selection of needed materials - minibag, vial, two 3 or 5 ml syringes, 2-regular needles, alcohol swabs 5.2 Swabs minibag transfer port and vial port with alcohol at least once (if multiple swabs all swabs should be in same direction) 5.3 Remove 2ml from vial- attaches needle to syringe (Never touches syringe tip/plunger, or any part of the needle) , pulls syringe back to 2ml with air, inserts needle with bevel tip to prevent coring, adds air to maintain vial vacuum, pulls syringe plunger back to 2ml of culture media

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UKCMC Aseptic Technique Practical Exam

5.4 Transfer 2ml from vial to minibag- Swabs port of the minibag and injects volume into minibag port with aseptic technique 5.4 Remove 2ml from vial with new needle- attaches needle to syringe (Never touches syringe tip/plunger, or any part of the needle) , inserts needle with bevel tip to prevent coring, pulls syringe plunger back to 2ml 5.5 Transfer 2ml from vial to minibag- Swabs port of the minibag and injects volume into minibag port with aseptic technique 5.6 Partially used product - places sterile cover over vial, removes vial from hood, labels with date/time opened or beyond use date/time, concentration and initals

6 Vial to Minibag Transfer with Transfer Spike and Syringe (Growth Media Product 3) 6.1 Selection of needed materials - minibag, partial vial, two 3 or 5 ml syringes, 2-regular needles, alcohol swabs 6.2 Swabs minibag transfer port and vial port with alcohol at least once (if multiple swabs all swabs should be in same direction) 6.3 Attach transfer spike to vial - uses proper aseptic technique to open and insert

6.4 Remove 2ml from vial- pulls syringe plunger back to 2ml

6.5 Transfer 2 ml to minibag- attaches needle to syringe, injects into minibag port using aseptic technique 6.6 Remove 2ml from vial- pulls syringe plunger back to 2ml 6.7 Transfer 2 ml to minibag- attaches needle to syringe, swabs minibag porth then injects 2ml into minibag port using aseptic technique

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UKCMC Aseptic Technique Practical Exam

7 Dilution Simulation (Growth Media Product 4) 7.1 Selection of needed materials - minibag, partial vial with transfer spike, 2 or 3; 5 to 10 ml syringes, 2-3 regular needles, alcohol swabs 7.2 Remove 5ml from vial via transfer spike- pulls syringe plunger back to 5ml, attaches capped needle 7.3 Remove 5ml from minibag- Swabs minibag then pulls syringe plunger back to 5ml, caps syringe with needle 7.4 Adds contents of syringes into a 10ml syringe for final product aseptically capping syringe with a new needle 7.5 Swab minibag then transfer transfer contents of syringe 10ml to minibag 8 Minibag should be labeled with date of assessment, participant initials, and proctor initials. The bag should be incubated at room temperature for 14 days.

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