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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.

Completed USP 797 Consulting Services include the Following:

USP 797 Gap Analysis
USP 797 Corrective Action Plans
USP 797 Consulting Services
USP 797 JCAHO Compliance
Gap Analysis for USP 797
Corrective Action Plans for USP 797
Consulting Services for USP 797
JCAHO Compliance for USP 797