The Food and Drug Administration (FDA) rigorously checks all relevant documentation to ensure that facilities comply with 21 CFR 211.65(a). All utilities that might impact on product quality – such as steam, gases, heating, ventilation etc. – should be qualified and monitored. Gas system qualification includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Gas samples are taken during OQ and PQ and then analyzed according to agreed-upon specifications, which in most cases will be those laid down in the pharmacopoeia monographs.
Linde Gas offers a wide range of gas distribution system installations, including:
-
Industrial installations
-
Specialty gas installations (laboratories)
-
Specialty gas installations (GMP production)
-
Ultra-high pure installations (semiconductor)
-
Health care installations
Installation Qualification - Gas purity
The quality and consistency of any gas is only as good as the distribution system. It is therefore essential that one of the goals in designing and building such a system should be the exclusion of impurities. Our extensive HiQ® specialty gas portfolio includes equipment for laboratory use, but also ensures equipment that offers traceability and proper documentation. Traceable equipment ranges from simple components such as valves and regulators to complex systems such as gas panels and points of use. All of these can be provided with certificates of conformity to prove compliance with the FDA.