Transcript Ventilation of Health Care Facilities

Summary of USP 797 for
Compounding Sterile Preparations
Presented at: HFMADV Meeting
February 3, 2009
Presented by: Tom N. Petersen, P.E.
Environmental and Engineering Solutions, Inc.
www.eesolutions.net
Copyright Environmental and Engineering Solutions, Inc. 2009
Purpose of U.S. Pharmacopeia (USP)
797
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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.
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Joint Commission requires a gap analysis and
action plan for USP 797 compliance.
Overview of New USP 797
(6/1/08 Update)
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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
Overview of New USP 797
(6/1/08 Update) - continued
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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
PA State Board of Pharmacy’s Position
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USP 797 Special Notice on the web site:
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“…provisions of the USP are not part of the Pharmacy
Act’s substantive sections or Board regulations.”
HOWEVER…
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“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.”
Compounding Sterile Preparations (CSP)
Microbial Contamination Risk Levels
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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
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
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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
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Radiopharmaceuticals as CSPs
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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
Allergen Extracts as CSPs
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Unpreserved allergen extracts must fully comply with
797, but most allergen extracts are highly preserved.
Exempt from certain aspects under certain conditions:
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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.
Environmental Quality and Control
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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
Environmental Quality and Control
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Environmental Sampling
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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
Additional Personnel Requirement
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Training requirements –
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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
Personnel Cleansing and Garbing
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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
Disinfectant and Cleaning
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Maintenance of compounding areas is
overlooked and this was an extensively
updated portion of USP 797.
Designed to reduce bioburden in
compounding areas
Use sterile 70% IPA and germicidal
detergent
To be performed in ISO 5 environment very
frequently
Clean from cleanest to dirtiest
Use dedicated mops and cleaners
Questions?
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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 [email protected].