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Co-editor with Frederick Carleton, Validation of Aseptic Pharmaceutical
Processes, 27 Chapter text on the validation of systems utilized in
the production of sterile products. Published by Marcel-Dekker in January
of 1986.
ASIN: 0824773624
Available
at Amazon.com
Co-editor with Frederick Carleton, Validation of Pharmaceutical Processes:
Sterile Products, A revised and expanded [29 chapters] second edition
published December 1998.
Marcel Dekker; ISBN: 0824793846
Available
at Amazon.com
Co-editor with Dr. James Akers, Handbook on Isolation Technology:
Applications in the Healthcare Industry, text in development for anticipated
publication by Marcel-Dekker in 2000.
Agalloco, J., "Validation of Aseptic Processing", chapter in Validation
of Aseptic Pharmaceutical Processes, edited by J. Agalloco & F.
J. Carleton, Marcel-Dekker, New York 1986.
Agalloco, J., Der Bedrosian, J., "Retrospective Validation", chapter
in Validation of Aseptic Pharmaceutical Processes, edited by J.
Agalloco & F. J. Carleton, Marcel-Dekker, New York 1986.
Akers, J., Agalloco, J., "Aseptic Processing - A Current Perspective"
chapter in Sterilization Technology, edited by R. Morrissey &
G.B. Phillips., Van-Nostrand Reinhold, New York, 1993.
ASIN: 0442238320
Available
at Amazon.com
Agalloco, J., Akers, J., "Validation of Sterilization Processes" chapter
in Pharmeceutical Dosage Forms: Parenteral Medications, Volume
3, 2nd Edition, edited by K. Avis, L. Lachman & H. Liebermann. Marcel
Dekker, New York, 1993.
Marcel Dekker; ISBN: 0824790200
Available
at Amazon.com
Agalloco, J., "Isolation Technology, A Current Perspective", chapter
in Isolation Technology edited by J. Akers and C. Wagner, published
by InterPharm Press, Buffalo Grove, IL 1995.
Interpharm Press; ISBN: 0935184783
Available
at Amazon.com
Agalloco, J., Akers, J., "Validation of Aseptic Processing", chapter
in Validation of Pharmaceutical Processes: Sterile Products, edited
by J. Agalloco & F. J. Carleton, Marcel-Dekker, New York 1998.
Agalloco, J., "Sterilization In Place Technology and Validation", chapter
in Validation of Pharmaceutical Processes: Sterile Products, edited
by J. Agalloco & F. J. Carleton, Marcel-Dekker, New York 1998.
Agalloco, J., "Retrospective Validation", chapter in Validation of
Pharmaceutical Processes: Sterile Products, edited by J. Agalloco
& F. J. Carleton, Marcel-Dekker, New York 1998.
Agalloco,J., DeSantis, P., "Validation of Bulk Pharmaceutical Chemicals"chapter
in Bulk Pharmaceutical Chemical Production, edited by S. Nusim,
to be published by Marcel-Dekker.
Agalloco, J., DeSantis, P., "Validation and Facility Design" chapter
in Pharmaceutical Facilities: Planning, Construction and Start Up,
edited by W. Huber to be published by Marcel-Dekker.
Agalloco, J., "Practical Considerations in Retrospective Validation"
Pharmaceutical Technology, Vol. 7, No. 6, 1983.
Kovary, S., Agalloco, J., Gordon, B., "Validation of the Steam-in-Place
Sterilization of Disc Filter Housings and Membranes", Journal of Parenteral
Science and Technology, Vol. 37, No. 2, 1983.
Agalloco, J., Kochansky, D., "Validation of Microprocessor Controlled
Processes", Proceedings: Concepts and Principles for the Validation
of Computer Systems in the Pharmaceutical Industry, Pharmaceutical
Manufacturers Association, 1984.
Agalloco, J., DeSantis, P., "Applying the Life Cycle Concept to the Validation
of Computerized Systems, Pharm Tech Conference '85, Aster Publications,
1985.
Agalloco, J., "Process Validation and Computer Systems Validation - Similarities
and Differences", Proceedings: Concepts and Principles for the Validation
of Computer Systems in the Manufacture and Control of Drug Products,
Pharmaceutical Manufacturers Association, 1986.
File: doc1.pdf
Size: 25 KB
Agalloco, J., "The Other Side of Process Validation", Journal of
Parenteral Science and Technology, Vol. 40, No. 6, 1986.
File: doc2.pdf
Size: 17 KB
Agalloco, J., "The Use of Consultants in the Parenteral Industry", Journal
of Parenteral Science and Technology, Vol. 40, No. 6, 1986.
Agalloco, J., "Validation of Existing Computer Systems", Pharmaceutical
Technology, Vol. 11, No. 1, 1987.
File: doc3.pdf
Size: 21 KB
Bozenhardt, H., Agalloco, J., "Validation as a Critical Factor in Automating
a Pharmaceutical Plant", Proceedings of Interphex Conference,
New York, 1987.
Agalloco, J., Gordon, B., "Current Practices in the Use of Media Fills
in the Validation of Aseptic Processing", Journal of Parenteral Science
and Technology, Vol. 41, No. 4, 1987.
Bozenhardt, H., Agalloco, J.,"Validation as a Critical Factor in Automating
a Pharmaceutical Plant", Pharmaceutical Engineering, Vol. 7,
No. 5, 1987.
Agalloco, J., "Computer Systems Validation -- Staying Current: Change
Control", Pharmaceutical Technology, Vol. 14, No. 1, 1990.
File: doc4.pdf
Size: 49 KB
Agalloco, J., "Steam Sterilization-in-Place Technology", Journal
of Parenteral Science and Technology, Vol. 44, No. 5, 1990.
File: doc5.pdf
Size: 28 KB
Agalloco, J., "A Review of US FDA's Guideline on Aseptic Processing",
Journal of Parenteral Science and Technology, Vol 46, No.3, 1992.
Agalloco, J., "Points to Consider in the Validation of Equipment Cleaning
Procedures", Journal of Parenteral Science and Technology, Vol.
46, No. 5, 1992.
File: doc6.pdf
Size: 52 KB
Agalloco, J., "Validation - Yesterday, Today and Tomorrow", Proceedings
of Parenteral Drug Association International Symposium, Basel, Switzerland,
Parenteral Drug Association, 1993.
File: doc7.pdf
Size: 42 KB
Agalloco, J., Akers, J., "Current Practices in the Validation of Aseptic
Processing - 1992", Journal of Parenteral Science and Technology,
Vol. 47, No. 2, Supplement 1993.
Agalloco, J., "The Validation Life Cycle", Journal of Parenteral
Science and Technology, Vol. 47, No. 3, 1993.
File: doc8.pdf
Size: 38 KB
Agalloco, J., "Microbiological Evaluation and Monitoring of Cleanroom
Environments [Meeting Summary]", Journal of Parenteral Science and
Technology, Vol. 47, No. 4, 1993.
File: doc9.pdf
Size: 24 KB
Akers, J., Agalloco, J., Kennedy, C., "Experience in the Design and Use
of Barrier Isolator Systems for Sterility Testing", Proceedings of
Parenteral Drug Association International Symposium, Basel, Switzerland,
Parenteral Drug Association, 1994.
Agalloco, J. and Mascherpa, V., "Validation of a Computerized System
for Autoclave Control", Pharmaceutical Technology, Vol. 19, No.
1, 1995.
File: doc10.pdf
Size: 41 KB
Agalloco, J., "Testing during the Start-up and Performance Qualification
of Computerized Systems in the Pharmaceutical Industry", Pharmaceutical
Technology, Vol. 19, No. 3, 1995.
File: doc11.pdf
Size: 46 KB
Agalloco, J., "Validation - An Unconventional Review and Reinvention",
PDA Journal of Pharmaceutical Science and Technology, Vol, 49,
No. 4, 1995.
File: doc12.pdf
Size: 46 KB
Agalloco, J., "Opportunities and Obstacles in the Implementation of Barrier
Technology", PDA Journal of Pharmaceutical Science and Technology,
Vol 49, No. 5, 1995.
File: doc13.pdf
Size: 39 KB
Agalloco, J., "Barriers, Isolators, Evolution and Revolutionary Ideas",
The Cleanroom Monitor, 1996.
Agalloco, J., "Qualification and Validation of Environmental Control
Systems", PDA Journal of Pharmaceutical Science and Technology,
Vol. 50, No. 5, 1996.
File: doc14.pdf
Akers, J., Agalloco, J., "Sterility and Sterility Assurance", PDA
Journal of Pharmaceutical Science & Technology, Volume 51, No.
2, 1997.
File: doc15.pdf
Agalloco, J., Akers, J., "Current Practices in the Validation of Aseptic
Processing - 1996", PDA Technical Report #24, PDA Journal of Pharmaceutical
Science and Technology, Volume 51, No. 2, supplement, 1997.
Akers, J., Agalloco, J., Madsen, R., "Moist Heat Sterilization - Myths
and Realities", PDA Journal of Pharmaceutical Science and Technology,
Vol. 52, No. 6, 1998.
File: doc16.pdf
Agalloco, J., "Barriers, Isolators and Microbial Control", PDA Journal
of Pharmaceutical Science and Technology, Vol. 53, No.1, 1999.
File: doc17.pdf
Agalloco, J., "Validation of Steam Sterilization in Autoclaves", Presentation
for Fedegari Sterilization Conference, Decemeber 1999.
File: doc21.pdf
Wasynchuk, J., Agalloco, J., et al, "Validation of Aseptic Drug Powder
Filling Processes", Parenteral Drug Association, Technical Report
No. 6, 1984.
Harris, J., Agalloco, J., et al, "Validation Concepts for Computer Systems
used in the Manufacture of Drug Products", Proceedings: Concepts and
Principles for the Validation of Computer Systems in the Manufacture and
Control of Drug Products, Pharmaceutical Manufacturers Association,
1986.
Gordon, B., Agalloco, J., et al, "Sterilization of Pharmaceuticals by
Gamma Irradiation", Journal of Parenteral Science and Technology,
Technical Report #11, Vol 42, Supplement 3, 1988.
Akers, J., Agalloco, J., Carleton, F., Korczynski, M., "A Review of Current
Technology in Parenteral Manufacturing", Journal of Parenteral Science
and Technology, Vol. 42, No. 2, 1988.
Thiboutot, R., Agalloco, J., et al, "Aseptic Processing and Terminal
Sterilization", Journal of Parenteral Science and Technology,
Vol. 45, No. 6, 1991.
Aydlett, J., Agalloco, J., et al, "PDA Presentation at the Food and Drug
Administration Open Conference on Sterile Drug Manufacturing", PDA
Journal of Pharmaceutical Science and Technology, Vol. 48, No. 1,
1994.
File: doc18.pdf
Kemper, C., Agalloco, J., et al, "Validation of Computer-Related Systems",
PDA Journal of Pharmaceutical Science and Technology, Technical
Report #19, Vol. 49, No. 1, Supplement 1995.
Agalloco, J., Conrad, D., et al, "Process Simulation Testing for Aseptically
Filled Products", PDA Technical Report #22, PDA Journal of Pharmaceutical
Science and Technology, Vol. 50, No. 6, supplement, 1996.
Agalloco, J., et al, "Process Simulation Testing for Sterile Bulk Pharmaceutical
Chemicals", PDA Technical Report #28, PDA Journal of Pharmaceutical
Science and Technology, Vol. 52, No. 4, supplement, 1998.
Madsen, R., Agalloco, J., et al, "Points to Consider for Cleaning Validation",
PDA Technical Report #29, PDA Journal of Pharmaceutical Science and
Technology, Vol. 53 No. 1 supplement, 1999.
Agalloco, J., et al, "Validation of Steam Sterilization", major revision
of PDA Technical Monograph #1 in progress. Current draft can be found
at on the PDA website at pda.org in the members only area.
Haberer, K., Madsen, R., Agalloco, J., et al, "Parametric Release of
Sterile Pharmaceuticals", PDA Technical Report #30, PDA Journal of
Pharmaceutical Science and Technology, Vol. 53, No. 4, p. 217, 1998.
Akers, J., Agalloco, J., et al, "Design and Validation of Isolator Systems
for the Manufacturing and Testing of Health Care Products Validation of
Steam Sterilization", PDA Technical Report #32 in progress.
Akers, J., Agalloco, J., et al, " PDA's Response to FDA's "Guideline
on Sterile Drug Products Produced by Aseptic Processing"", Journal
of Parenteral Science and Technology, Vol. 42, No. 4, 1988.
Agalloco, J., "PDA and Me -- and Possibly You", Journal of Parenteral
Science and Technology, Vol. 43, No. 1, 1989.
Akers, J., Agalloco, J., "Comments on the Calculation of Sterility Assurance
Levels", Journal of Parenteral Science and Technology, Vol. 44,
No. 6, 1990.
Akers, J., Agalloco, J., "Commentary on The USP's Proposed Microbial
Limits for Aseptic Processing Areas", Journal of Parenteral Science
and Technology, Vol. 45, No. 1, 1991.
File: doc19.pdf
Agalloco, J. & Akers, J., "Letter to the Editor - re: Apples, Oranges
and Additive Assurance", Journal of Parenteral Science and Technology,
Vol. 46, No. 1, 1992.
Agalloco, J., et al, "PDA's Response to FDA's Proposed Rule: Use of Aseptic
Processing and Terminal Sterilization in the Preparation of Sterile Pharmaceuticals
for Human and veterinary Use", Journal of Parenteral Science and Technology,
Vol. 46, No. 3, 1992.
Conrad, D., Booth, C., Agalloco, J., et al, "PDA Comments on EU Guide
to Good Manufacturing Practice; Annex on the Manufacture of Sterile Medicinal
Products", PDA Journal of Pharmaceutical Science and Technology,
Vol 50, No. 3, 1996.
Agalloco, J., "Letter to the Editor - re: Validation - An Unconventional
Review and Reinvention", PDA Journal of Pharmaceutical Science and
Technology, Vol. 50, No. 5, 1996.
Akers, J., Agalloco, J. & Madsen, R., "PDA Comments on PIC Recommendations
on Isolator Technology, Validation of Aseptic Processing and Sterility
Testing, 1998.
Agalloco, J., "Letter to the Editor - re: It just doesn't matter", PDA
Journal of Pharmaceutical Science and Technology, Volume 52, No.
3, 1998.
File: doc20.pdf
Akers, J., & Agalloco, J., "Isolators - Validation and Sound Scientific
Judgement", Pending publication in PDA Journal of Pharmaceutical Science
and Technology
File: doc22.pdf
Agalloco, J., "Steam Sterilization & Steam Quality", PDA Journal
of Pharmaceutical Science and Technology, Volume 54, No. 1, 2000.
File: doc23.pdf