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PDA Revises Flagship Technical Report on Steam Sterilization

Document to Be Unveiled at Public Workshop in Chicago, June 26-27

The Parenteral Drug Association (PDA) has published Technical Report No. 1 (Revised 2007), "Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control," an update to PDA Technical Monograph No. 1, "Validation of Steam Sterilization Cycles" (1978), the Association's flagship technical guide to industry. The completed document will be officially unveiled at a workshop in Chicago, June 26-27, at the Hyatt Regency McCormick Place (go to www.pda.org/tr1). PDA members will receive the report as part of their regular membership in July; others can purchase the document from www.pda.org/bookstore.

"Technical Monograph No. 1 introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers," says PDA President Bob Myers, who relied on the document as an expert on moist heat sterilization during his 28-year career with Schering-Plough Corporation. "The updated version retains the focus on the microbiology and engineering of moist heat sterilization and the general approach to sterilization science contained in the original document, but now provides sufficient technical detail to assist in developing a sterilization policy acceptable in all the regions in which our industry operates. A new chapter on thermal science is included to broaden the document."

The 2007 revision is intended to be a single-source overview that complements existing documents listed in its comprehensive reference section. Works cited are appropriate and up-to-date scientific publications, international regulatory documents, journal articles, technical papers and books.

PDA will revise and publish additional technical reports and books that spun out of the Technical Report No. 1 project. These include:

--  Technical Report No. 3 (Revised), "Validation of Dry Heat Processes
    Used for Sterilization and Depyrogenation"
--  Technical Report No. 30 (Revised), "Parametric Release"
--  New Technical Report, "Biological Indicators for Sporicidal Gassing
    Processes: Production, Control and Use"
--  New Technical Report, "Steam in Place"
--  New Technical Report, "Sterilizer Systems: Design, Commissioning,
    Operation, Validation and Maintenance"
--  Technical Book, "Microbiology and Engineering Sterilization Processes"
    

A PDA volunteer task force of 40 scientists from North America and Europe worked on the revision of Technical Report No. 1, producing a technical guide on moist heat sterilization that should be applicable in all regulatory environments.

"I was pleased and excited to work with this highly talented group," says PDA Senior Vice President of Scientific and Regulatory Affairs Rich Levy, Ph.D. "The task force was composed of volunteers representing the industry, health authorities and academia who generously dedicated numerous hours to PDA and the goal of producing the best scientific and internationally acceptable guidance on steam sterilization available."

The volunteer task force for Technical Report No. 1 set a new standard in developing PDA technical guidance for the pharmaceutical and biopharmaceutical industry by initiating a comprehensive peer review of its work. For the first time, a PDA task force presented drafts of the document at public conferences and distributed advanced copies via the web for feedback. Conferences in Cork (Ireland), London (UK) and Pavia (Italy) successfully generated commentary from PDA stakeholders in Europe, including feedback from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). A fourth conference in Bethesda, Md., provided perspectives on the document from U.S. stakeholders.

"These feedback sessions were critical to establishing the international and scientific credibility of Technical Report No. 1," says former FDA compliance officer Kristen Evans (now with Amgen Inc.), who participated on the PDA task force. "I thoroughly enjoyed working on the task force. As I look back on my public health career, which was principally focused on sterile drug policy and compliance, I would say completing the report was one of the accomplishments I am most proud of."

The task force and contributors for PDA Technical Report No. 1 (Revised 2007), "Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control":

James P. Agalloco, Agalloco & Associates
James E. Akers, Ph.D., Akers Kennedy & Associates
Wilf Allinson, GlaxoSmithKline
Thomas J. Berger, Ph.D., Hospira
Frank Bing, Abbott Laboratories (retired)
Göran Bringert
GE Kaye Instruments
Gary Butler, Steris Corporation
Jean-Luc Clavelin, Eli Lilly & Co.
Peter Cooney, Ph.D., FDA (retired)
Phil DeSantis, Schering-Plough
Peter Dürr, F. Hoff-mann-La Roche AG
Kristen D. Evans, FDA
John G. Grazal, AstraZeneca
Nigel Halls, Ph.D., IAGT. Ltd.
Paul Hargreaves, MHRA
Andrew D. Hopkins, MHRA
Martin A. Joyce, Ph.D., GeneraMedix Inc.
David Karle, Steris Corporation
Bernard Kronenberg, Bakrona Basel AG
John W. Levchuk, Ph.D., FDA (retired)
Richard V. Levy, Ph.D., PDA
Steen Loevtrup, Novo Nordisk A/S
Timothy F. Lord, Eli Lilly & Co.
Genevieve Lovitt-Wood, G.I. Lovitt & Associates
Russell E. Madsen, The Williamsburg Group, LLC
Vittorio Mascherpa, Ph.D., Fedegari Autoclavi Spa (retired)
David W. Maynard, Maynard & Associates
Robert B. Myers, PDA
James E. Owens, Baxter Healthcare (retired)
Irving Pflug, Ph.D., University of Minnesota (retired)
Dario Pistolesi, Ph.D., Fedegari Autoclavi Spa (retired)
Anthony Pochiro, AG Edwards and Sons
Jarmo Saari, Leiras OY
Michael Sadowski, Baxter Healthcare
John T. Shirtz, Baxter Healthcare
Keith Shuttleworth, Keith Shuttleworth & Associates Ltd.
Finlay Skinner, Skinner Pharm-Assist
Ian Symonds, GlaxoSmithKline
Kevin D. Trupp, Hospira
Dieter Witthauer, Ph.D., Novartis
Richard T. Wood, Ph.D. (retired)
William Young, Baxter Healthcare (retired)

Because of the strong outpouring of support for and participation in the peer-review process for Technical Report No. 1, PDA is now using the model for all of its technical report projects. Over the next year, PDA expects to publish at least one technical report per edition of the "PDA Journal of Pharmaceutical Science and Technology" through the end of 2008, including the following reports nearing completion:

--  Technical Report No. 39 (Revised 2007), "Guidance for Temperature
    Controlled Medicinal Products"
--  Technical Report No. 43, "Identification and Classification of
    Nonconformances in Molded and Tubular Glass Containers for Pharmaceutical
    Manufacturing"
--  New Technical Report, "Filtration of Liquids Using Cellulose-Based
    Depth Filters"
--  Technical Report No. 15 (Revised 2007), "Tangential Flow Filtration"
    

About PDA Technical Reports

PDA Technical Reports are drafted by all-volunteer task forces sanctioned by the Association's volunteer advisory boards and Board of Directors. These reports are intended for regulator and industry guidance on scientific and operational subjects pertaining to the pharmaceutical and biopharmaceutical industry. Over 40 titles are currently available in PDA's library of technical reports. All can be purchased at www.pda.org/bookstore. Like Technical Report No. 1, a number of these documents have been revised and updated. When first published, technical reports are distributed to the PDA membership and subscribers to the PDA Journal of Pharmaceutical Science and Technology.

About PDA

Connecting People, Science and Regulation®

The Parenteral Drug Association (PDA) is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at www.pda.org.

About the PDA Journal of Pharmaceutical Science and Technology

The PDA Journal of Pharmaceutical Science and Technology (The Journal), established in 1946, is considered to be one of the most relevant and highly cited vehicles for peer-reviewed scientific and technical papers in the pharmaceutical and biopharmaceutical industries. The Journal is published bimonthly and is distributed to the PDA membership as a member benefit. The Journal is also available by subscription to industrial, university, and public libraries, as well as to government agencies.