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