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Regulatory Topics
Aseptic Processing Isolators

The highlights of this presentation by a leading FDA-CDER authority on aseptic processing isolator systems include basic design and validation approaches as well as feedback by FDA inspectors on various isolator applications during pre-approval inspections.
Qualification and Regulatory Issues for a CBER Licensed Isolated Filling Line

The regulatory process for the CBER licensing of an isolated filling line is discussed, including media fill data and FDA feedback from the pre-approval inspection (PAI) and FDA response letter.
Room and Isolator Air Classification Requirements

The question of what air classification is required for the inside of your isolator and the surrounding room is reviewed with regard to US and EU guidelines.

       Key Aspects of PDA Technical Report #34: Design and Validation of Isolator Systems for the Manufacturing and testing of Health Care Products

       Sorting through the USP and EP Requirements related to Sterility Testing in Isolators

       Sterility Claims and Contamination Risks in Isolators