Services and Supplies to Meet USP Requirements Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation and Medication Safety Cardinal Health Pharmacy Solutions

2 Objectives Identify required garb Review supply requirements Explain certification parameters

3 Agenda - Supplies Garb IV Room supplies Cleaning products Hand scrubs Cleaning sterile areas Monitoring Agar plates, strips, other media Media-fill test kits

4 Agenda - Services Certification of hoods and rooms Electronic air sampling

5 Garb Hair covers Head and facial hair Masks Booties Gowns Regular and chemo Gloves Regular and chemo Powder-free

6 Placement of Garb Neat Appropriate sizes Wire rack Wall units To minimize or cover paper or cardboard containers

7 IV Room Supplies Syringes Needles Transfer pins Wipes Dry and wet Sterile alcohol

8 Placement of Supplies Minimize cardboard Use plastic bins Minimize amount of supplies in the clean areas Sticky mats

9 Chemo Prep Supplies Eye protection Chemo spill kits Transport bags

10 CSTD Closed-system vial transfer device System required if laminar air flow workbench and BSC in same room

11 Sterile Containers used for CSPs Sterile container: Acceptable Non-sterile container: Unacceptable

12 Trash Regular trash Sharps Chemo trace Non-hazardous pharmaceutical waste RCRA

13 Developing a List of Products Basic list Specialty products Based on what your are compounding

14 Hand Washing Surgical scrub Solution Brush Gels Air dryer Lint-free cloths

15 Cleaning and Disinfecting Cleaning Removes loose materials and residue Disinfecting Sanitizes the surface

16 Cleaning the Sterile Area Pails Mops Disposable Lint-free Solutions Need to be approved by hospital’s Infection Control Committee

17 Routine Monitoring Temperature records Log for room temperature Log or graphs for refrigerators and freezers

18 Monitoring Media-fill kits Agar plates, strips, media Neutralized so valid with disinfectants Caseine soy broth TSB Petri dish

19 Hood Certification Primary Engineering Controls (“hoods”) Secondary Engineering Controls Buffer area Ante area Segregated Compounding Area Particle counter Electronic air sampling

20 Hood Certification Contract Old days Particle count every six months in each hood Now Particle count, validation of pressure/velocity readings, electronic air sampling every six months Each Primary Engineering Control (hood, isolator) All buffer and ante areas

21 Primary Engineering Control Laminar air flow workbench Biological safety cabinet Compounding aseptic isolator Compounding aseptic containment isolator

22 Secondary Engineering Controls Buffer area Where the PECs are located Ante area Area outside the buffer area

23 Environmental Monitoring Particle count Pressure or velocity reading confirmation Electronic air sampling

24 Certification Report Review with certifier Ask for executive summary Pass / fail What needs to be corrected Follow up areas with concerns

25 Resources USP ASHP Guidelines Compounding Sterile Preparations Hazardous Drugs Outsourcing Ophthalmics TPN

26 Q&A