|
USP 797 Project
Management
USP 797 Consulting Services
USP 797 : Jump-Starting Your Pharmacy into Compliance
© William N. Bernstein, LEED®AP, AIA - 2005
By
now, if you are a hospital manager, you’ve probably heard about it : USP 797.
But what is it exactly, and what architectural and environmental changes are
most likely required to bring your pharmacy into compliance?
To begin with, USP 797 is a fairly recent regulation, designed both to cut
down on infections transmitted to patients through pharmaceutical products and
also to better protect staff working in pharmacies in the course of their
exposure to pharmaceuticals. Issued by U.S. Pharmacopeia (USP), the regulation
governs any pharmacy which prepares --- as most do --- “compounded sterile
preparations” (CSPs).
The reason USP 797 has become such a big deal in the health care environment
can be summed up in five letters : JCAHO. Having endorsed USP 797, JCAHO now
mandates compliance according to the following schedule :
- 07/01/04: JCAHO began surveying for compliance with USP 797
- 07/31/05: JCAHO deadline for an “Approved Facility Renovation Plan” (AFRP)
- 07/31/08: JCAHO deadline for completion of construction of the AFRP
Now USP 797 is a far-reaching regulation that governs a wide-range of
pharmacy policies and procedures. This article focuses only on the architectural
and environmental changes that WP 797 will likely require in your pharmacy.
The first step in the process of compliance is the categorization of your
pharmacy into one of the following categories: “Low-Risk Level CSP”,
“Medium-Risk Level CSP”, or “High-Risk Level CSP”
A complete explanation of the parameters of “Low”, “Medium”, and “High-Risk
Level” is outside the scope of this article. A flavor of these categories,
however, can be obtained via the following examples of compounding:
Examples of Low-Risk Compounding :
- “Single transfers of sterile dosage forms from ampuls, bottles, bags and
vials using sterile syringes with
sterile needles, other administration
devices and other sterile containers…”
- “Manually measuring and mixing no more than three (3) manufactured
products to compound drug
admixtures…”
Examples of Medium-Risk Compounding :
- “Compounding of total parenteral nutrition fluids using manual or
automated devices…”
- “Filling of reservoirs of injection and infusion devices with multiple
sterile drug products…”
- “Filling of reservoirs of injection and infusion devices with volumes of
sterile drug solutions…”
- “Transfer of volumes from multiple ampuls or vials into a single final
sterile container or product”
Examples of High-Risk Compounding :
- “Dissolving nonsterile bulk drug and nutrient powders to make solutions
which will be terminally sterilized”
- “Sterile ingredients, components, devices and mixtures are exposed to air
quality inferior to ISO Class 5…”
- “Measuring and mixing sterile ingredients in nonsterile devices before
sterilization is performed.”
- “Assuming, without appropriate evidence or direct determination, that
packages of bulk ingredients
contain at least 95% by weight of their active
chemical moiety and have not been contaminated or
adulterated between uses.”
The over-riding physical requirement of USP 797 is the creation of two zones
: a “Buffer Room” (in general, where the sterile compounding is done) as well as
an “Anteroom” (in general, where non-sterile compounding activities occur such
as hand washing, storage, measuring/weighing/mixing of non-sterile substances,
etc.).
There is a critical difference, however, between the configuration of Buffer
Room and Anteroom in a Low, Medium or High Risk environment. In a Low or Medium
Risk environment, the Buffer Room and Anteroom can be in one shared room. In a
High Risk environment, however, the Buffer Room and Anteroom must be separated
by a wall with a door.
USP 797 provides additional direction on the cleanliness or purity of the air
in the Buffer Room. To begin with, actual compounding of sterile substances must
be done in a “laminar airflow workbench” (LAFW), which must provide an air
purity micro-environment of IS0-5 (equivalent to a “Class 10” cleanroom). The
ISO-5 LAFW, in turn must be located in the Buffer Room which must itself provide
air quality equal to ISO-8 (equivalent to a “Class 100,000” cleanroom). To
complicate matters a bit, there is current discussion that the Buffer Room air
purity level requirement may be raised to ISO-7 in the next version of the
regulations.
A final area worth noting is the guidelines for architectural finishes in the
Buffer Room. All surfaces --- ceiling, walls, floors, fixtures, shelving,
counters and cabinets --- should be “smooth, impervious, free from cracks and
crevices, and nonshedding…”. Junctures of ceilings to walls should be coved.
Wall construction should be either a locked panel system or epoxy-coated gypsum
board. Floors should be sheet vinyl with heat-welded seams and coved base.
Exterior surfaces of lighting fixtures should be smooth, mounted flush and
sealed. There should be no sinks or floor drains in this area, and work surfaces
should ideally be stainless steel.
Is your pharmacy environment USP 797 compliant? Contact Bernstein &
Associates, Architects to discuss : USP 797 Gap Analysis reports, USP 797
Compliance Action Plans, USP Design and Construction services, and a schedule
for USP 797 Compliance.
Project Management Services for : USP 797 Consulting Services
- USP 797
Project Management
- USP 797 Construction Management
- USP 797 Owner’s Rep
- USP 797 Project Manager
- Project Management for USP 797
- Construction Management for USP 797
- Owner’s Rep for USP 797
- Project Manager for USP 797
|
