21 CFR Part 11 Tag

20 Nov Gas Analyzers (O2, CO2, N2) for Pharmaceutical Product Packaging

Posted at 08:33h in A.KRÜSS Optronic Products by AGS Scientific

Gas Analyzers (O2, CO2, N2) for Monitoring Modified Atmosphere Packaging in Pharmaceutical Products The use of a gas such as oxygen (O2), nitrogen (N2) or carbon dioxide (CO2) or a mixture of gases is commonly used in pharmaceutical packaging such as injection vials, liquid vials, pouches...

08 Nov 21 CFR Part 11 Compliant Instruments

Posted at 08:48h in A.KRÜSS Optronic Products by AGS Scientific

21 CFR Part 11 Compliant Instruments for the Pharmaceutical Laboratory The US Food and Drug Administration (FDA) requires that FDA-regulated facilities, such as the pharmaceutical industry, comply with software regulations that are contained in the Code of Federal Regulations (CFR), Title 21, Part 11 in a...