04 Jun USP 797 Cleanrooms: Definition, Requirements, and Design

USP 797 is more than just a set of guidelines; its rules were designed to protect patients. And it does this by making sure sterile medications are prepared safely in controlled environments.

A cleanroom is one such environment, and one of the most important of any manufacturing operation that needs to prevent contamination.

In this article, we’ll cover what a USP 797 cleanroom is, what it requires, and more.

What Is a USP 797 Cleanroom?

A USP 797 cleanroom is a special space where sterile medications are prepared according to standards in USP Chapter 797. The cleanroom’s main purpose is to reduce or prevent contamination during compounding. (Compounding is simply the mixing of drugs or ingredients to tailor medications to individual patients.)

To meet USP 797 guidelines, a cleanroom must control factors like air quality, airflow, pressure, temperature, humidity, and even how staff behave. USP 797 cleanrooms are used in many places, including hospitals, pharmacies, clinics, and other healthcare spaces. Despite all the technical details, the goal is fairly simple, and that is to make sure that any sterile medication prepared in the space is safe for patient consumption, and all that entails.

USP 797 Cleanroom Requirements

To meet USP 797, a cleanroom has to follow specific rules for air quality, pressure, layout, and cleanliness practices in general. As you might expect, these rules are in place to keep contaminants like dust, bacteria, and other particles out of the sterile compounding area.

A typical USP 797 cleanroom is made up of three connected spaces that work together to protect the medication.

First, there’s the anteroom, which is where staff enter the clean area, wash their hands, put on gowns (as a kind of gowning room), and prepare any supplies before compounding. It acts as a kind of airlock between the rest of the building and the cleanroom, and it is usually an ISO Class 8 space.

Next is the buffer room, where the compounding itself takes place. This room must be cleaner than the anteroom and is where the primary engineering controls (PECs) are, such as laminar airflow workbenches (LAWFs) and biological safety cabinets (BSCs). The air in the buffer room must meet ISO Class 7 standards, and it should also have positive pressure so that air flows out of the room rather than allowing outside air in.

Inside the PECs is where space is the cleanest. The medication is mixed in LAFWs or BSCs, which have to create ISO Class 5 air quality.

Together, these three zones, the anteroom, the buffer room, and the PECs, create a controlled system that moves from less clean to cleaner, progressively, so that by the time the medication is actually compounded, it’s being done in the safest possible environment.

Cleanroom Layout and Design

We’ve already explained how USP 797 cleanrooms are designed in part, especially how areas are progressive, from less strict spaces to stricter ones. However, these spaces also have to be built in such a way that makes them easy to keep clean. As a result, surfaces in the building, including walls, ceilings, and floors, are typically made from non-porous, easy-to-clean materials; also, such surfaces will have to be smooth and without cracks where bacteria and other particles may linger.

The air inside the cleanroom will also, as is standard, be filtered through HEPA filters. Pressure is also controlled to make sure clean air moves outward and not the other way around, as we’ve mentioned already. Many of these spaces also use pass-through chambers so supplies can enter the cleanroom without opening doors.

Monitoring and Maintenance

Furthermore, even if a USP 797 cleanroom is perfectly built, it won’t stay clean on its own. Things like air quality, particle counts, and microbial levels in certain areas need to be checked regularly. Pressure differentials also need to be maintained and checked, and temperature and humidity must stay within specific ranges.

Daily cleaning tasks must also be logged, and surfaces are disinfected in a set order, starting with the cleanest areas. If any reading falls outside the required limits, the issue has to be corrected and documented right away.

Staff Training and Gowning

Finally, the people inside the cleanroom are often the biggest source of contamination, so proper training and gowning are an absolute necessity. USP 797 requires training in sterile compounding techniques, along with testing to prove staff can work safely.

Before entering the space, staff follow strict gowning routines that include things like handwashing, putting on sterile gloves, gowns, face masks, head covers, and more. Consistency is important, as even a small mistake in gowning or behavior can put the entire space at risk.

The Bottom Line

In short, a USP 797 cleanroom is a space made to prevent compounded drugs from becoming contaminated. Such an environment must meet strict standards for things like air quality, pressure, design, gowning, and staff protocol. If USP 797 standards aren’t met, the medication may not be safe, which could cause serious legal troubles and risks to patients.

Interested in setting up USP 797-compliant cleanrooms at your location? Reach out to the experts at Allied Cleanrooms to get a quote on new controlled environments today.

FAQs About USP 797 Cleanrooms

1. Can modular cleanrooms meet USP 797 requirements?

Yes, absolutely. Modular cleanrooms can be designed and built to fully meet USP 797 guidelines. They are an especially flexible/scalable choice for compounding facilities that need quick installation or foresee future expansion.

2. How big does a USP 797 cleanroom need to be?

There’s no specific size required by USP 797. The size will depend on how much sterile compounding you’ll need to carry out, the number of staff in the space, etc. The space will also need to be large enough to meet ISO classifications and allow for proper separation of zones.

3. Can USP 797 cleanrooms be retrofitted into an existing building?

Yes, absolutely. Many facilities can retrofit unused rooms to create compliant cleanrooms, and this is especially feasible using modular construction. Of course, modifications will also need to meet airflow, pressure, and material requirements.