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Summary of USP 797 for Compounding Sterile

Preparations

Presented at: HFMADV MeetingPresented at: HFMADV MeetingFebruary 3, 2009February 3, 2009

Presented by: Tom N. Petersen, P.E.Presented by: Tom N. Petersen, P.E.Environmental and Engineering Solutions, Inc.

www.eesolutions.net

Copyright Environmental and Engineering Solutions, Inc. 2009

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Purpose of U.S. Pharmacopeia (USP) 797

For pre-administration phase of sterile preparations - Reduces the potential for contamination caused by unclean environment, pharmacist error, lack of quality control, incorrect beyond-use dating and other factors.

Joint Commission requires a gap analysis and action plan for USP 797 compliance.

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Overview of New USP 797 (6/1/08 Update)

Introduction and Organization of the Chapter – (direct contact is principal source of contamination)

CSP Microbial Contamination Risk Levels Single–Dose v. Multiple Dose Containers Hazardous Drugs as CSPs Radiopharmaceuticals as CSPs Allergen Extracts as CSPs Sterilization Methods – three methods were

revised and a new section on depyrogenation (removal of pyrogens – endotoxins or exotoxins) added

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Overview of New USP 797 (6/1/08 Update) - continued

Environmental Quality and Control Exposure of Critical Sites – exposure to “first

air” from HEPA Placement of Primary Engineering Controls Additional Personnel Requirement Personnel Cleansing and Garbing Disinfectant and Cleaning Five Appendices – shall vs. should,

checklists, suggestions for garbing

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PA State Board of Pharmacy’s Position

USP 797 Special Notice on the web site: “…provisions of the USP are not part of the Pharmacy

Act’s substantive sections or Board regulations.”

HOWEVER…

“Section 5(a)(12) of the Pharmacy Act provides that the departure from, or failure to conform to, the standards of acceptable and prevailing pharmacy practice is grossly unprofessional conduct.”

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Compounding Sterile Preparations (CSP) Microbial Contamination Risk Levels

Immediate Use CSPs – for non-haz only, 1 hr. after start of preparation must be administered

Low-Risk Level Low-Risk Level w/12 hour or less Beyond Use Date

(BUD) – subsection of low risk, designed for facilities with no ISO 7 secondary control clean room

Medium-Risk Level High-Risk Level Responsibility of personnel to determine level

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Single–Dose vs. Multiple Dose Containers

Single dose vials (SDV) – if opened or punctured in ISO 5 area may be used for up to 6 hours.

Single dose ampuls must be discarded and not stored

MDV – 28 day BUD

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Hazardous Drugs as CSPs

Protecting the workers from exposure to certain drugs during preparation

References NIOSH Alert regarding choosing the appropriate Primary Engineering Control (PEC)

Recommends PEC that do not recirculate air Biological safety cabinets (BSC) or

Compounding Aseptic Containment Isolator (CACI) should be vented to the outside

Locate in separate negative pressure ISO Class 7 with ISO Class 7 ante area

Disposal of waste according to state and federal regulations

Equipment

High Risk Immuno-

compromised Patients

Infection Control Risk Assessment (ICRA)

Immunocompromised Patients

Inpatient

Invasive Imaging Procedure Room

Non-Aspirating Diffuser

Protective Environmental Room

Triage

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Radiopharmaceuticals as CSPs

Must be prepared in an ISO 5 containment device in an ISO 8 environment or cleaner

Principals of ALARA followed (As low as reasonably achievable)

Allowance for preparation of radiopharmaceuticals under the Low-Risk Level with 12 hr BUD – hot labs in hospitals have better chance of compliance as long as they have ISO Class 5 PEC

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Allergen Extracts as CSPs Unpreserved allergen extracts must fully comply with

797, but most allergen extracts are highly preserved. Exempt from certain aspects under certain conditions:

Hand hygiene PPE used Simple aseptic transfer Contain effective amount of preservative Single patient only Gloves are disinfected with IPA Vial stoppers disinfected Labeling requirements

Exemption granted based on a study with 27,000 subjects and no infections.

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Environmental Quality and Control

Laminar air flow workbenches (LAFW), BSC, CAI, CACI

ISO Class 5 sources, buffer areas and ante areas – there is a circular diagram conceptual representation of the layout – concentric circles of control

Secondary engineering controls for buffer area and ante area and have HEPA filtered air sources

The recirculating ISO Class 5 devices count towards the overall 30 air changes per hour for the buffer Class 7 area

Airflow and balance testing required at installation site

There is an exception for CAI’s related to providing isolation from the room – if secondary engineering control ISO 7 not available

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Environmental Quality and Control - continued

Environmental Sampling Designed to demonstrate a suitable

environment for aseptic compounding Electronic measurement of the total number

of airborne particles Certification of ISO 5, 7, and 8 environments Volumetric air sampling of viable

microorganisms Glove fingertip monitoring Surface sampling

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Additional Personnel Requirement

Training requirements – Classroom instruction and written exam plus

observational evaluation Garbing Aseptic work practices

Maintaining ISO Class 5 environment Media-fill testing of aseptic work skills Outside support personnel must also be

trained properly

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Personnel Cleansing and Garbing

Remove outer garments and jewelry, makeup, including earbuds and headsets

Garb from dirtiest to cleanest parts of body Shoe covers, hair covers, beard covers and face

masks, even if have no hair Hand/arm hygiene Disposable non-shedding gowns Sterile powder-free gloves compatible w/ IPA Repeatedly apply IPA to contact areas of gloves Immediate use provision (emergency situation)

does not have garbing requirements

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Disinfectant and Cleaningo Maintenance of compounding areas is

overlooked and this was an extensively updated portion of USP 797.

o Designed to reduce bioburden in compounding areas

o Use sterile 70% IPA and germicidal detergent

o To be performed in ISO 5 environment very frequently

o Clean from cleanest to dirtiesto Use dedicated mops and cleaners

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Questions?

For questions or assistance with regard to indoor air quality and infection control for hospitals, contact Tom Petersen, P.E. at 215-881-9401, or by email at tom@eesolutions.net.