Air flow smoke pattern testing: a new challenge in a subjective test in Annex 1 EU GMP

In the maintenance process of aseptic facilities, one of the tests of high importance is the 'Air flow smoke pattern testing' to demonstrate the correct operation of aseptic production equipment in Grade A/ISO 5 and Grade B/ISO 6 environments. This is a mandatory test required by the new Annex 1 EU GMP regulation for sterile production when the product is exposed to environmental conditions. This case study illustrates the complexity of the test in achieving compliance with the requirements of Annex 1 EU GMP and the necessary steps to meet the standard's objectives.