After a cleanroom has been certified, the cleanroom is often than qualified to demonstrate and document that the environmental conditions in the classified cleanrooms are suitable for manufacturing or compounding. As part of the qualification program, the sampling plan shall be risk based as required by ISO 11644 and ISO 14698. As such, organizations are required to document a risk assessment in order to develop a monitoring plan.
The FDA requires that manufacturers of pharmaceuticals, including compounding pharmacies, qualify and validate the disinfection procedures used in manufacturing and cleanroom environments in order to demonstrate the procedures are effective in inactivation or removal of microorganisms. Disinfectant efficacy testing protocols are designed and performed per guidance available in ASTM E 2315, USP <1072>, and ASTM E 26140.