Moist heat sterilization--myths and realities.
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Drug Industry↗
Biomedical subjects
J P Agalloco
Publications and source records attributed to J P Agalloco.
Considerations in sterile filtration. Part II: the sterilizing filter and its organism challenge: a critique of regulatory standards.
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Evaluation Studies as Topic↗
PDA's response to FDA's "Guideline on sterile drug products produced by aseptic processing".
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Antisepsis↗
A review of current technology in parenteral manufacturing.
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Antisepsis↗
Current practices in the use of media fills for the validation of aseptic processing.
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Antisepsis↗
The other side of process validation.
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Drug Industry↗
The use of consultants in the parenteral industry.
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Drug Industry↗
Validation of the steam-in-place sterilization of disc filter housings and membranes.
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Sterilization↗
Experience in the design and use of isolator systems for sterility testing.
The use of isolator systems for sterility testing is on the increase. Prior to installation and validation careful consideration must be given to the type of barrier to be used, and the design of the facility which will house the barrier system. The validation of these systems requires development and testing of the sterilization cycle. Vapor phase hydrogen peroxide has proven to be efficacious in this application, and examples of sterilization cycle development are presented in this paper. Also of concern is the penetration of sterilant into test articles, media and supplies.
Equipment Design↗