Clean Room Validation

Within highly regulated environments such as medical device and pharmaceutical industries, there is a requirement to provide an appropriate amount of assurance that critical processes can be performed within controlled conditions in order to produce a final product that is of eminent quality, reliable, and safe for the consumer.

Incepbio performs cleanroom HVAC validations as per ISO 14644-1:2,2,3(2015), EU GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) & NABH guidelines for all room classifications. We work with a range of clients from start-up labs to the world’s largest pharmaceutical and biotech companies.