While the class of “cleanliness” is dictated by the standards and industry in different fields, designing and building a cleanroom requires many other factors crucial to the success of the result. A common and typical use of cleanroom is for compounding Pharmacies supervised by different regulatory bodies and standard organizations. USP (United States Pharmacopeia) is the main organization defining the standards and regulations in United States.
Specifically, USP 797, and USP 800 are defining the standard and quality for “pharmaceutical compounding – sterile preparation” and “hazardous drugs – handling in health care settings” respectively. Both 797 and 800 chapters have gone through extensive review and development for the past couple of years. In the light of current changes in USP 797 and 800, NAPRA (National Association of Pharmacy Regulatory Authorities) the Canadian equivalent, has offered its own set of revised and extended model standards for hazardous and non-hazardous sterile preparations as well as non-sterile hazardous preparations. In specific case of Canadian compounding pharmacies, it is noteworthy that it is the provincial college of pharmacist that decides and execute which standard and what requirement will be enforced.
Although the FED USD 209E has been canceled, its classifications is still widely referred to in the industry.
Above short description is meant to Segway into other crucial factors in design and building of a cleanroom.
Protecting Personnel or process/product plays a role in defining the pressure of cleanroom in comparison to the adjacent rooms. This idea is also closely related to, as if it’s the other side of same coin, whether the subjected process/product is hazardous or non-hazardous.