Cleanroom testing and certification
New rooms, annual recertification, after room modifications
Main standard: ISO 14644
Temperature & Humidity Mapping
New pharmaceutical warehouses, layout changes, periodic studies
Main standard: WHO Technical Report Series No. 961 (2011) Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (Supplements 8, 10, 12, 14, 15)
Duct leakage testing
New duct installations, duct replacement, renovation or energy-saving projects
Main standard: SMACNA
DQ IQ OQ PQ
New or modified systems, before production starts
Main standards: EU GMP Annex 15, PIC/S PE 009-17
VH₂O₂ area decontamination
Before a room is used, after maintenance, after a contamination event
Main standard: PIC/S GMP Annex 1
Compressed dry air (CDA)
Compressed air in contact with product, periodic testing
Main standard: ISO 8573-1:2010