Services and Supplies to Meet USP <797> Requirements

Patricia C. Kienle, RPh, MPA, FASHPDirector, Accreditation and Medication SafetyCardinal Health Pharmacy Solutionspatricia.kienle@cardinalhealth.com

2

Objectives

Identify required garbReview supply requirementsExplain certification parameters

3

Agenda - Supplies

GarbIV Room suppliesCleaning products

Hand scrubsCleaning sterile areas

MonitoringAgar plates, strips, other mediaMedia-fill test kits

4

Agenda - Services

Certification of hoods and roomsElectronic 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

NeatAppropriate sizesWire rackWall units

To minimize or cover paper or cardboard containers

7

IV Room Supplies

SyringesNeedlesTransfer pinsWipes

Dry and wetSterile alcohol

8

Placement of Supplies

Minimize cardboard

Use plastic binsMinimize amount

of supplies in the clean areas

Sticky mats

9

Chemo Prep Supplies

Eye protectionChemo spill kitsTransport 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-sterilecontainer:Unacceptable

12

Trash

Regular trashSharpsChemo trace Non-hazardous pharmaceutical waste RCRA

13

Developing a List of Products

Basic listSpecialty products

Based on what your are compounding

14

Hand Washing

Surgical scrubSolutionBrush

GelsAir dryerLint-free cloths

15

Cleaning and Disinfecting

CleaningRemoves loose materials and residue

DisinfectingSanitizes the surface

16

Cleaning the Sterile Area

PailsMops

Disposable Lint-free

SolutionsNeed to be approved by hospital’s Infection

Control Committee

17

Routine Monitoring

Temperature recordsLog for room

temperatureLog or graphs for

refrigerators and freezers

18

Monitoring

Media-fill kitsAgar plates, strips, media

Neutralized so valid with disinfectantsCaseine soy brothTSBPetri dish

19

Hood Certification

Primary Engineering Controls (“hoods”)Secondary Engineering Controls

Buffer areaAnte area

Segregated Compounding AreaParticle counter

Electronic air sampling

20

Hood Certification Contract

Old daysParticle count every six months in each hood

NowParticle 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 workbenchBiological safety cabinetCompounding aseptic isolatorCompounding aseptic containment

isolator

22

Secondary Engineering Controls

Buffer areaWhere the PECs are located

Ante areaArea outside the buffer area

23

Environmental Monitoring

Particle count Pressure or velocity reading

confirmation Electronic air sampling

24

Certification Report

Review with certifierAsk for executive summary

Pass / failWhat needs to be corrected

Follow up areas with concerns

25

Resources

USP <797>ASHP Guidelines

Compounding Sterile PreparationsHazardous DrugsOutsourcingOphthalmicsTPN

www.pppmag.com

26

Q&A