Isolators

1. Isolators

2. Ventilation Controls • When asepsis is not required, a Class I Biological Safety Cabinet (BSC) or a containment isolator may be used to handle hazardous drugs. • When sterile hazardous drugs are being compounded, a Class II BSC or III BSC or an isolator intended for aseptic preparation and containment is required.

3. Type A2 (formerly type B3): Class II BSCs • A Class II BSC has an open front with inward airflow for personnel protection,downward HEPA-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection,a common exhaust plenum, may exhaust HEPA- filtered air back into the laboratory or to the environment through an exhaust canopy. • Effectiveness of such cabinets depends on operators’ use of proper technique.

4. Isolator • Isolator may be considered a ventilated controlled environment that has fixed walls, floor, and ceiling. • For sterile preparations: ISO class 5 for filtered air and airflow as a way to minimize the challenges of a traditional cleanroom and some of the disadvantages of the Class II BSC. • The totally enclosed design may reduce the escape of contamination during the compounding process. The isolator may be less sensitive to drafts and other laminar-airflow equipment, including positive-pressure environments (a fixed-glove assembly).

5. Horizontal Laminar Flow Clean Bench DO NOT USE FOR HAZARDOUS DRUGS!! Diagram courtesy of Duane Hammon, Ken Mead, Div. of Applied Research and Technology, Engineering and Physical Hazards Branch, CDC.

6. Environment • Keep potentially contaminated PPE away • from face, skin • NEVER eat or drink in hazardous • drug prep area • Wear gown properly What NOT to do today….. Photos courtesy of Robert DeChristoforo, MS Deputy Chief, Pharmacy Dept., NIH Clinical Center Pharmacy

7. Photo courtesy of Luci A. Power, MS Senior Pharmacist, Manager, UCSF-IV Additive Service

8. Photo courtesy of Luci A. Power, MS Senior Pharmacist, Manager, UCSF-IV Additive Service

9. Recommendations for Working in BSCs and Isolators 1. The use of a Class II or III BSC or isolator must be accompanied by a stringent program of work practices, including operator training for contamination reduction, and decontamination. 2. Do not place unnecessary items in the work area of the cabinet or isolator where hazardous drug contamination from compounding may settle on them. 3. Do not overcrowd the BSC or isolator. 4. Gather all needed supplies before beginning compounding. Avoid exiting and reentering the work area of the BSC or isolator.

10. Recommendations for Working in BSCs and Isolators 5. Appropriate handling of the preparation in the BSC or pass-through of the isolator, including spraying or wiping with 70% alcohol or another appropriate disinfectant, is necessary for aseptic compounding (The work surface of the safety cabinet should be covered with plastic-backed absorbent paper. This will reduce the potential for dispersion of droplets and spills and facilitate cleanup). 6. Reduce the hazardous drug contamination burden in the BSC or isolator by wiping down hazardous drug vialsbefore placing them in the BSC or isolator. 7. Transport bags must never be placed in the BSC or the isolator work chamber during compounding to avoid inadvertent contamination of the outside surface of the bag.

11. Recommendations for Working in BSCs and Isolators 8. Final preparations should be surface decontaminated within the BSC or isolator and placed into the transport bags in the BSC or in the isolator pass-through, taking care not to contaminate the outside of the transport bag. 9. Decontaminate the work surface of the BSC or isolator before and after compounding per the manufacturer’s recommendations or with detergent, sodium hypochlorite solution, and neutralizer. 10. Decontaminate all surfaces of the BSC or isolatorat the end of the batch, day, or shift, as appropriate to the workflow. Typically, a BSC or isolator in use 24 hours a day would require decontamination two or three times daily. Disinfect the BSC or isolator before compounding a dose or batch of sterile hazardous drugs.

12. Recommendations for Working in BSCs and Isolators 11. Wipe down the outside of the Class II BSC front opening and the floor in front of the BSC with detergent, sodium hypochlorite solution, and neutralizer at least daily. 12. Seal and then decontaminate surfaces of waste andsharps containersbefore removing from the BSC or isolator. 13. Decontamination is required after any spill in the BSC or isolator during compounding. 14. Seal all contaminated materials (e.g., gauze, wipes, towels, wash or rinse water) in bags or plastic containers and discard as contaminated waste.

13. Recommendations for Working in BSCs and Isolators 16. Appropriate decontamination within the cabinet must be completed before the cabinet is accessed via the pass-throughs or removable front panels. 17. Gloves or gauntlets must not be replaced before completion of appropriate decontamination within the cabinet. 18. Surface decontamination of final preparations mustbe done before labeling and placing into the passthrough. 19. Final preparations must be placed into a transport bag while in the pass-through for removal from the cabinet.

14. It is the third measure to be taken in addition to organizational measures and the technical equipment

15. 6- Personal Protective Equipment Appropriate Personal Protective Equipment (PPE) • Gloves • Gowns • Eye Protection • When splashing is possible • Respirator/masks • For aerosols & spill clean-up • Shoe & Hair covering Source: Safe handling of cytotoxic drugs: an independent study module. 2nd ed. Pittsburgh (PA): Oncology Nursing Society; 1997. p26

16. ASHP Guidelines: Appendix C Recommendations for Use of Gloves • Double gloves for all activities involving hazardous drugs • Powder-free, latex, nitrile, polyurethane, neoprene, other materials meeting ASTM standard for chemotherapy gloves • Inspect for visible defects • Sanitize with 70% alcohol or other disinfectant • CHANGE GLOVES EVERY 30 MINUTES or immediately when damaged or contaminated

17. ASHP Guidelines: Appendix C Recommendations for Use of Gloves • Remove outer gloves after wiping down final prep but before labeling or removing from BSC • Place outer gloves in a containment bag within the BSC • Wear a second glove inside the fixed glove within an isolator • Clean fixed gloves after compounding is complete • Wash hands before gloving and after removing gloves

18. Photo courtesy of Luci A. Power, MS Senior Pharmacist, Manager, UCSF-IV Additive Service

19. Photo courtesy of Luci A. Power, MS Senior Pharmacist, Manager, UCSF-IV Additive Service

20. Personal Protective Equipment

21. Training on Handling of Hazardous Medications Appropriate Personal Protective Equipment (PPE) - continued • Gowns • Wear gowns that are disposable, made of a lint-free, low-permeability fabric. • They should have a solid front (back closure) and knit or elastic cuffs. • Laboratory coats and other cloth fabrics absorb fluids, so they provide an inadequate barrier to hazardous drugs and are not recommended. Source: Safe handling of cytotoxic drugs: an independent study module. 2nd ed. Pittsburgh (PA): Oncology Nursing Society; 1997. p26

22. ASHP Guidelines: Appendix D Recommendations for Use of Gowns • Should be worn during compounding, administration, handling waste from patients recently treated with hazardous drugs, and cleaning up (small) spills of hazardous drugs • Coated gowns (polyethylene or vinyl coatings) may be worn up to 3 hours. Uncoated polypropylene and polypropylene-polyethylene copolymer provide little protection.

23. ASHP Guidelines: Appendix D Recommendations for Use of Gowns • Gowns should be disposed immediately as contaminated waste upon removal and not hung up for later use in the pharmacy compounding area. • Gowns are still prudent when using an isolator or Class III BSC due to possible exposure outside the cabinet. • Wash hands after removing and disposing of gowns.

26. 7- Technical Equipment • 3-layer work underlay • Sterile compresses and swabs • Single-use syringes • Cannulas (needles) • Container for discarded cannulas • Waste container • Closed system, Drug-transfer devices (Mixing adaptor, phaseal,…)

27. 8- Manipulative Procedures • General Techniques (Use of luer-lock syringes….) • Aseptic & Negative pressure Techniques • Validation: • Rooms with respect of cleaning and hygiene • Cytostatics workbench • Work materials • Starting materials • Aseptic Technique: Demonstration of Competence

30. What is a Closed-System? “A closed system drug transfer device mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system” NIOSH* * National Institute for Occupational Safety & Health