What is USP 797 Clean Room and Its Guidelines?

The USP general chapter 797 is a regulation and is used as a basis for setting cleanliness standards in sterile compounding areas. These areas include biosafety cabinets, compounding aseptic containment isolators, and compounding aseptic isolators. Laminar airflow workbenches, buffer areas, ante areas, and segregated compounding areas are also on the list. Keeping these areas clean and sterilizing them kills or significantly minimizes the risk of microbial contamination during compounded sterile preparations, Research & Development says.

How should the cleaning proceed?
The USP 797 sets written standard operating procedure along with cleaning logs. Both aim to ensure the quality of the environment to get ready for the preparation of the CSPs. Chapter 797 then provides how the cleaning should go, what procedures it should include, steps on how to go about the cleaning process along with how frequent the cleaning must be. The chapter also includes information on what supplies should be used for the work.

Where do I start?

The cleaning will generally start from the cleanest areas to the dirtiest. To effectively prevent cross-contamination, cleaning must also follow this rule: go from top to bottom rule. If you need an example, then here’s how it goes. If you find yourself in a room, then start from the walls and windows and work your way to the exteriors of your process equipment, the cabinets, countertops, and other horizontal surfaces until you reach the floors.

What is it for?

The aim of the USP general chapter 797 is to prevent infections in patients when they use pharmaceutical products. The regulations, when properly followed, will also keep members of the pharmacy staff from being exposed to possible harmful pharmaceutical products or those that may trigger adverse physical reactions or irritations.

What are the risk levels?

Low-risk conditions refer to environments that have an ISO class 5 or better air quality using only sterile ingredients. Medium-risk conditions apply to situations that include having multiple individual or small doses of sterile products compounded or pooled to prepare an item that will be administered to multiple patients or to one patient multiple times. High-risk conditions wherein the non-sterile ingredients are incorporate or non-sterile devices used before terminal sterilization. What happens then is that sterile ingredients along with components, mixtures, and devices are exposed to ISA class 5.

How do I design a cleanroom?

Aside from the cleanroom requirements set by the USP chapter 797, you must also be compliant with the performance parameters that measure HEPA filters along with cleanroom classification, pressurization, air changes, and more.

Choosing cleanroom equipment

If you need assistance in how to turn your cleanroom compliant with the USP chapter 797, then start looking for the right cleanroom equipment. Consider companies that offer cleanroom machines and tools that can eliminate compliance issues. What kind of track record does the firm have, though? What kind of background? Does the company have the resources and range of choices you need? Find out when you reach out to the firm for more details. With the right cleanroom technology and equipment, you can reduce and even prevent the incidence of airborne infection.

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