Health care organizations that compound sterile formulations are getting a head start on compliance with the USP 797 guidelines, courtesy of the JCAHO (Joint Commission on Accreditation of Healthcare Organizations).

According to the American Society of Health Systems Pharmacists, beginning July 1, the JCAHO will be surveying health care institutions, pharmacies, physician practices and other facilities in which sterile compounding is performed. The purpose is to verify compliance with the “major requirements of General Tests and Assays Chapter 797 regardless of whether an organizations state, by virtue of law or regulation, requires such compliance”.

One of the 19 elements slated to be surveyed is “environment design of drug preparation rooms.” The critical elements we are going to focus on here are, room design, material/personnel flow, equipment layout, surface materials and serviceability. Whether the subject room is new or one that is being modified, the most critical element is good planning. We all know that no matter how much we plan, there will always be deviations. With that in mind, let’s talk about what we can do to get the most out of the “controllable” elements of room design.

The role of the designer and the builder is distinct. Whether separate entities or a design-build company is your choice, the most critical prerequisite is how familiar they are with the specific environment you need to achieve and maintain. This is true regardless of whether you are building a new facility or upgrading an existing facility.

In the case of a sterile compounding environment, the goal is an aseptic or sterile environment in which you can control the risk of microbial contamination and cross-contamination of admixtures or compounds. Contamination can be found on surfaces as well as in the air, but what you are concerned about is beyond simple particulate contamination.

The first question you and the designer or design-builder should ask is: “what type of contamination is of concern?” It is not enough for a room to achieve a “classification” that reflects only the ability to remove and maintain a standard of particulate control. A designer-builder must demonstrate an understanding of this concept as well as significant experience relative to your specific type of environment.

There are some basic guidelines in the USP 797 that address room design. This is where you need to stop and assess the space to be built or modified. For the “low to medium risk” rooms, there must be an ante room, or more accurately, an ante area. This area does not need to be separated by a physical wall, as is the case for “high-risk” rooms.

The ante room or area can be achieved with something as simple as a strip curtain, preferably outside of the cleanroom. This area is provided as a processing area for personnel, materials and equipment. The ante room/area should be sized based on the number of technicians that will be working in the compounding room at any given time. The area should be able to store an adequate amount of gowning supplies (we will talk more specifically about gowning and recommended components to don for the various environments next time). Also, if possible, the ante room/area should not be part of a high traffic area or corridor.

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