What’s Important When Designing a Clean Room?

Clean room design is not easy. In fact, it requires detailed knowledge, planning, and precision. It also involves tackling issues in logical sequences. When done correctly, the result is a clean and sterile environment. The compounding process requires this type of sterile environment.

Many compounding pharmacies use USP chapters 797 and 800 as a template for designing their clean room. Unfortunately, this template fails to take into consideration many factors, including contamination risks. To reduce these risks, it is important to put extra care and thought into the design of your clean room.

When Designing a Clean Room, Consider These Steps

Step One: Consider the People or Material

To reduce the risk of contamination, a well-designed clean room should evaluate both the people and the material flow within the room. After all, workers are the largest contamination source. One of the easiest ways to reduce contamination is to isolate critical processes. Be sure to place these stations far away from personnel access doors and pathways.

Step Two: Use a Three-Room Design

The goal of a clean room is to reduce the risk of contamination. This is especially important when making compounded sterile pharmaceutical preparations.

To do this, clean rooms need to have enough space for all pre-sterilization activities. This includes using autoclaves and weighing out sterile powders. It also needs to have separate spaces for the aseptic processes, as well as hand washing and gowning activities.

A three-room design provides the right amount of space for all processes to occur without contamination. To do this, a clean room design often includes a buffer area and two anterooms.

Step Three: Determine Space Cleanliness and Pressurization

Different processes need a different level of cleanliness. Sterile compounding, for example, is an ISO 5. Pharmaceutical compounding is an ISO 7. When connecting two spaces together, there should be no more than two orders of difference in cleanliness classification between them.

Clean rooms often have complex mechanical systems, and their design should take these systems into consideration. When designing a clean room, it is important to plan for the pressurization of those spaces. Maintaining a positive air space pressure is essential to preventing contamination.

Step Four: Maintain Sanitary Conditions

The FDA provides guidance for designing a clean room. This includes clean room designs observed at compounding facilities to be unsanitary. When a compounding pharmacy prepares drugs under unsanitary conditions, the government may recall the facility’s products.

Any clean room design should address FDA guidelines and avoid unsanitary conditions, such as:

● Loose ceiling tiles

● Overhangs that collect dust

● Water sources in buffer rooms

● Equipment that affects airflow

● Inadequate pressure differentials

● HEPA filters that are not sealed

● HEPA air returns that are not near the floor

● Difficult to clean production areas

These are just a few of the steps that compounding pharmacies should consider when designing their clean room. While constructing and operating a clean room is not cheap, efficient design can help improve efficiency and reduce product contamination.

About Dr. Ross Caputo

Clean room design is an essential component to any compounding pharmacy. At Eagle, our president Ross Caputo has the experience to understand these design issues. As a respected member of the pharmaceutical industry, Ross Caputo Ph.D. has articles published in over 50 publications. His 30 plus years of experience in the industry has helped our product quality testing facility grow. We hope this information can help other facilities improve as well.