Application Note: Microbiological considerations in cleanroom validation
Contamination, microbiological or otherwise, is a key safety concern in the development and manufacture of all pharmaceuticals and medical devices.
Ensuring that a product or device has been manufactured to all relevant pharmacopoeial regulations and is within any specified microbial limits is crucial when considering the effect of a contaminated product in the market.
Cleanrooms and other controlled environments play a vital role in manufacturing and testing processes through the control of airborne and surface contamination as the levels of particles allowed within these environments are strictly regulated.
Cleanroom grading systems are governed by a number of regulatory bodies and standard-setting organisations, with classification assessing the level of cleanliness of the environment against a specified range.
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