Home > USP 797 Compliance > Do I need a cleanroom?

Do I Need a Cleanroom Like Those Used in a Manufacturing Environment?

Since the publication of USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations in January 2004, facilities that compound sterile preparations have been trying to find the best and most cost-effective way to comply with the new regulations.

USP 797 deals with policies and practices for compounded sterile preparations (CSP), and is the first official and enforceable requirement for CSPs.

One issue USP 797 addresses is standards and requirements for reducing CSP contamination caused by an unclean environment. Air quality and cleanliness affects the likelihood of microbial contamination. Dust, dirt, pollen, skin flakes, lint, and cosmetics can all introduce contamination. To avoid this contamination, do you need to install a full cleanroom like those used in manufacturing environments? Or are there acceptable alternatives for compounding facilities?

Do I Need a Cleanroom?

Anyplace where CSPs are prepared must meet USP 797 requirements. So if you prepare CSPs, does this mean you need a cleanroom? Not necessarily. Your goal as a facility that prepares CSPs is to create an aseptic or sterile environment in which you can control the risk of microbial contamination and cross-contamination of admixtures or compounds. A cleanroom, with its HEPA filters and low dust levels, is certainly an alternative - possibly the best alternative - to achieving this environment. However, with the cost of installing a cleanroom starting at $150/square foot, their cost can be prohibitively expensive. In addition, cleanrooms have high operating costs and take up valuable floor space.

What is the Alternative to a Cleanroom?

As an alternative to cleanrooms, USP 797 specifically allows the use of barrier isolators. Barrier isolators can take the place of a cleanroom by providing cleanroom conditions within a contained workspace. Barrier isolators offer several advantages:

• Workers have no direct with the work area. Instead, they access the work area via sealed gloves. This isolation eliminates the largest source of contamination in compounding - people.
• Barrier isolators take up far less valuable floor space than do cleanrooms.
• Workers do not have to fully gown before they begin work, which can save nearly an hour of work time.
• Decontamination is easier in the small, contained environment of the barrier isolator.

The A2 Pharmacy Isolator provides an excellent alternative to a cleanroom.

It provides the same level of air quality a cleanroom does, while taking up less space and being more cost-effective to operate. Even better, the A2 Pharmacy Isolator is easy to use, easy to clean, and easy to sanitize. It is fully adjustable, making it comfortable to use, and includes an Uninterruptible Power Supply (UPS), making it safe and reliable.

Where Can I Put an Isolator?

If you choose to install a barrier isolator, keep in mind that the location of the isolator is very important. USP 797 doesn't require that you locate your barrier isolator within a buffer area or cleanroom that maintains at least an ISO Class 8 environment; however, this environment is preferred. If you don't have an ISO Class 8 area to house your isolator, you must at least keep the environment as clean and sterile as possible. You want to minimize as much as possible any contamination that could occur as you transfer products into and out of the barrier isolator. The A2 Pharmacy Isolator addresses this issue by including a transfer chamber that acts as an air lock. When you place materials in this chamber, the ventilation system cleans the air in the background chamber up to class 100 quality.

Other options for improving cleanliness levels include:

• Installing HEPA filters in the ceiling fans
• Replacing ceiling tiles with "cleanroom grade" tiles
• Removing refrigerators, computers, and printers from the compounding area
• Replacing flooring with seamless vinyl floor covering
• Implementing proper housekeeping procedures for cleaning and sanitizing