PDA Technical Methods Bulletins: Print

Environmental Monitoring: A Compilation of Papers from the PDA Journal of Pharmaceutical Science and Technology (paper ship version)

A Compilation of Papers from the PDA Journal of Pharmaceutical Science and Technology.

In response to a need for finding historical papers, members of the PDA Microbiology Committee conducted a review of the PDA Journal of Pharmaceutical Science and Technology from 1985 to 1995, and selected these papers which should have value for those working in this field.

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Table of Contents:

I. Airborne Sampling – Evaluation of Air Samplers

• Efficiency of “Biotest RCS” as a Sampler of Airborne Bacteria – 1988 by Saul Kaye
• Review of Commercially available Particulate Measurement Systems
Part I – Instrumentation – 1988 by Julius Z. Knapp and Patrick P. DeLuca
Part II – A Selected annotated Bibliography on Particulate Matter – 1988 by Patrick P. DeLuca, Bice Conti, and Julius Z. Knapp
• Some Aspects on the Use of the Biotest RCS Air Sampler in Unidirectional Air Flow Testing – 1990 by Bengt Ljungqvist and Berit Reinmuller
• Airborne Microbial Challenges of Blow/Fill/Seal Equipment: A Case Study – 1990 by A. Bradley, S.P. Probert, C.S. Sinclair, and A. Tallentire
• The Biotest RCS Air Samplers in Unidirectional Flow – 1993 by Bengt Ljungqvist and Berit Reinmuller

II. Airborne Sampling – Sampling Methods
• Airborne Bacteria Sampling: The Effect of Dehydration and Sampling Time – 1986 by W. Whyte and L. Niven
• Sterility Assurance and Models for Assessing Airborne Bacterial Contamination – 1986 by W. Whyte
• Microbiological Environmental Monitoring during Sterile Product Manufacture: Adaptation of Methods for a Research Facility – 1988 by G.J. Slater and D. Johnston
• Development of a Non-Viable Particulate Monitoring System for Drugs Manufactured in an Aseptic Environment – 1991 by Nate Morgan

III. Validation
• Current Practices in the Use of Media Fills for the Validation of Aseptic Processing – 1987 by James P. Agalloco and Barbara M. Gordon
• Microbiological Validation of a New Manufacturing Complex for an Injectable Biological Product – 1990 by Michael C. Carroll, Marjorie Van Pala, and Linda Vollherbst
• Technical Report: Bioburden Recovery Validation – 1990 by PDA Bioburden Recovery Validation Task Force
• Validation and Environmental of Aseptic Processing – 1990 by Committee on Microbial Purity
• Validation of Environmental Monitoring Methods and Levels – 1992 by Norma Howell Noble

IV. Training
• Gowning Training: The Use of Video Recording Together with Microbial Assessment – 1990 by Carole L. Beer
• Training Cleanroom Personnel – 1991 by Anne Marie Dixon

V. Regulatory Commentary
• Control Aspects of Aseptically Produced Products – 1984 by Henry L. Avallone
• FDA Update on GMPs For Aseptic Processing – 1985 by Edmund M. Fry
• FDA Update on Aseptic Processing Guidelines – 1986 by Edmund M. Fry
• PDA Response of FDA “Guidelines on Sterile Drug Products Produced by Aseptic Processing” – 1988 by Ad-hoc Committee of the PDA Research Committee
• Current Regulatory Issues Regarding Sterile Products – 1990 by Henry L. Avallone
• Commentary on the USP’s Proposed Microbial Limits For Aseptic Processing Areas – 1991 by James Agalloco and James Akers
• Should the United States Pharmacopeia Define Manufacturing Process Limits? by Michael S. Korczynski
• A Review of the U.S. FDA Guideline on Aseptic Processing – 1992 by James Agalloco
• Investigational Trends: Clean Room Environmental Monitoring – 1992 by Ronald F. Tetzlaff
• PDA Comments on USP In-Process Revision <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments – 1995 by PDA.

VI. PDA Technical Reports & Miscellaneous
• Movement of Air Flow, Peripheral Entrainment, and Dispersion of Contaminants – 1987 by Hugh Howorth
• Report on Survey of Current Industry Gowning Practices – 1990 by PDA Gowning Task Force
• Rapid/Automated ID Methods Survey – 1990 by PDA Microbial ID Task Force
• Fundamentals of a Microbiological Environmental Monitoring Program – 1990 by PDA Environmental Task Force
• A Comparison of Two Commercially Irradiated Trypticase Soy Agars Containing Lecithin and Polysorbate 80 – 1991 by F. Marski and J. Fowler
• Current Practices in the Validation of Aseptic Processing – 1992 by James Agalloco and James Akers
• Microbiological Evaluation and Monitoring of Cleanroom Environments (Meeting Summary) – 1993 by James Agalloco
• Hazard Analyses of Airborne Contamination in Clean Rooms – Application of a Method for Limitation

Date of Publication: December 1996
ISBN Number:
Number of Pages: 220
Binding: Soft cover