Dosage Forms

Anthony M. Cundell is the director of microbiological development and statistics, Global Quality Technology, at Wyeth Pharmaceuticals, 401 N. Middletown Road, Pearl River, NY 10965-1299, tel. 845.602.2497, cundela@wyeth.com

Articles

The role of microbial testing to ensure the sterility of aseptically filled sterile products is explained, from the product development phase to in-process monitoring to finished product testing.

Microbial Testing in Support of Aseptic Processing

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.

Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

In spite of regulatory uncertainties, the industry continues to develop improved aseptic processing technologies.

The Future of Aseptic Processing?An Update

FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.

Aseptic Processing Guidelines and Innovative Engineering Boost Appeal of Barrier Isolators

Jeff L. Folks is director of business development at Quintiles (Kansas City, MO).

Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.

Aseptic Formulation and Filling Using Isolator Technology

Glenn E. Wright is chairman of the PQRI Aseptic Processing Working Group and a director of global regulatory affairs at Eli Lilly and Company.

Members of FDA, industry, and academia formed a working group within PQRI to openly discuss topics from a scientific perspective and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.

The PQRI Aseptic Processing Working Group: What was it? What Did It Cover? What Conclusions Did It Reach? Why Was It Important?

Richard L. Friedman is a microbiologist and is a senior compliance officer for sterile drugs and chairs CDER's Aseptic Processing Guideline Revision Working Group.

The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.

FDA Perspectives: Revising the 1987 Industry Guideline The Development of FDA's Guidance on Aseptic Processing

Anne Marie Dixon-Heathman  is the owner and president of Cleanroom Management Associates, Inc.

Training for aseptic processing cleanrooms must be a dynamic process to meet job requirements and industry demands. The author discusses various approaches that may be taken to ensure a successful training session.

Training for Aseptic Processing Environments

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

The recently issued FDA concept paper about aseptic processing shows how the current guidelines could be expanded and makes recommendations for alternatives to traditional cleanroom installations such as isolator-equipped aseptic filling lines and blow?fill?seal equipment.

Concept Paper Discusses Update of Aspetic Processing Guidelines

Shireesh P. Apte, PhD, is a lead scientist at Baxter I.V. Systems Inc.

As parenteral drug delivery becomes more complex and sophisticated, excipients that can facilitate drug (or gene) delivery to specific therapeutic targets will be required. An overwhelming majority of these excipients are derived from natural sources.

Parenterals and Injectables