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1.
Considerations in sterile filtration. Part II: the sterilizing filter and its organism challenge: a critique of regulatory standards.
Jornitz, M W; Akers, J E; Agalloco, J P; Madsen, R E; Meltzer, T H.
PDA J Pharm Sci Technol ; 57(2): 88-96, 2003.
Article in English | MEDLINE | ID: mdl-14674510

Subject(s)
Filtration/standards , Microbiological Techniques/standards , Sterilization/standards , Evaluation Studies as Topic , Guidelines as Topic , Reference Standards , Sterilization/legislation & jurisprudence
2.
Moist heat sterilization--myths and realities.
Agalloco, J P; Akers, J E; Madsen, R E.
PDA J Pharm Sci Technol ; 52(6): 346-50, 1998.
Article in English | MEDLINE | ID: mdl-10050136

Subject(s)
Drug Industry , Sterilization
3.
Experience in the design and use of isolator systems for sterility testing.
Akers, J E; Agalloco, J P; Kennedy, C M.
PDA J Pharm Sci Technol ; 49(3): 140-4, 1995.
Article in English | MEDLINE | ID: mdl-7613992

ABSTRACT

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.


Subject(s)
Sterilization/instrumentation , Equipment Design , Sterilization/standards , Temperature
4.
PDA's response to FDA's "Guideline on sterile drug products produced by aseptic processing".
Akers, J E; Agalloco, J P; Carleton, F J; Korczynski, M S.
J Parenter Sci Technol ; 42(4): 114-7, 1988.
Article in English | MEDLINE | ID: mdl-3183865

Subject(s)
Antisepsis/standards , Asepsis/standards , Pharmaceutical Preparations , Sterilization/standards , United States Food and Drug Administration , Reference Standards , Societies, Pharmaceutical , United States
5.
A review of current technology in parenteral manufacturing.
Akers, J E; Agalloco, J P; Carleton, F J; Korczynski, M S.
J Parenter Sci Technol ; 42(2): 53-6, 1988.
Article in English | MEDLINE | ID: mdl-3385542

Subject(s)
Antisepsis/standards , Asepsis/standards , Infusions, Parenteral/standards , Environmental Monitoring , Quality Control , Sterilization/instrumentation , Sterilization/standards , United States
6.
Current practices in the use of media fills for the validation of aseptic processing.
Agalloco, J P; Gordon, B M.
J Parenter Sci Technol ; 41(4): 128-41, 1987.
Article in English | MEDLINE | ID: mdl-3668756

Subject(s)
Antisepsis/standards , Asepsis/standards , Technology, Pharmaceutical , Drug Industry , Surveys and Questionnaires
7.
The other side of process validation.
Agalloco, J P.
J Parenter Sci Technol ; 40(6): 251-2, 1986.
Article in English | MEDLINE | ID: mdl-3819977

Subject(s)
Drug Industry/standards , Technology, Pharmaceutical/standards , Quality Control
8.
The use of consultants in the parenteral industry.
Agalloco, J P.
J Parenter Sci Technol ; 40(6): 277-83, 1986.
Article in English | MEDLINE | ID: mdl-3819981

Subject(s)
Drug Industry , Legislation, Drug , United States Food and Drug Administration , Referral and Consultation , United States
9.
Validation of the steam-in-place sterilization of disc filter housings and membranes.
Kovary, S J; Agalloco, J P; Gordon, B M.
J Parenter Sci Technol ; 37(2): 55-64, 1983.
Article in English | MEDLINE | ID: mdl-6864408

Subject(s)
Sterilization/methods , Technology, Pharmaceutical/instrumentation
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