Description:
Product sterility cleanroom testing is required for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free of viable microorganisms. The cleanroom is a classified space where laboratory analysts are equipped with special gowns and precautions to avoid introducing bioburden into the test area where they perform aseptic manipulation of products to test for sterility. This test is carried out in accordance with the recommendations of
USP 71
USP 161
USP 797
EP 2.6.1
JP 14 54
ANSI/AAMI/ISO 11737
AAMI TIR33
Keywords:
Product Sterility – Cleanroom