Manufacturing

Dave Abram is manager of validation and technical services at BioConvergence LLC, 4320 West Zenith Drive, Bloomington, IN 47404, tel. 812.961.1700, fax 812.961.1733.

Articles

The author details the factors in formulation design, requirements in facilites and equipment, and validation criteria for aseptic formualtions.

Current Perspectives on Aseptic Formulations

Investing time and money in auditing and optimizing a steam system can pay off quickly, especially because the costs of energy, maintenance, and downtime are steadily rising.

The Economical and Process Benefits of Steam-System Audits

Devices that measure relative humidity (e.g., sensors and transmitters) play a relatively small role in cleanroom management, but their failure can cause significant problems. Operators should bear several factors in mind to ensure that sensors function properly and maintain the appropriate humidity.

Ensuring Accurate Humidity Measurement in Cleanrooms

A novel cleanroom apparel design incorporates modern concepts to help minimize contamination. Take a tour of the design.

Donning by Design: Sterile Cleanroom Gowning Evolves to Help Minimize Contamination Risk

Theodore H. Meltzer is principle of Capitola Consultancy.

Jean-Marc Cappia is vice-president of marketing for fluid management technology at Sartorius Stedim Biotech FMT, Aubagne, France.

The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.

Disposable Components in Aseptic Processing

Yoshi Izumi is executive vice-president at Shibuya Hoppmann Co., a subsidiary of Shibuya Kogyo, Co. Ltd.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.

The Impact of Automation on Aseptic Processing

Maurizio Battistini is the general manager of APP Pharmaceutical Partners in Switzerland.

The author discusses the key issues to consider when using isolators such as containment, protection of personnel, the efficiency of biodecontamination cycles, sterility assurance levels, barriers and their integrity, and environmental impact.

Manufacturing High-Potency Drugs Using Isolators

Hood, suit, faceplate, cover shoes, gloves: these are the necessary items of clothing when operating in A-and B-grade areas.

A detail often overlooked: goggles in aseptic production

In light of the rising price of stainless steel components and facility construction, pharmaceutical companies are increasingly using disposable components and systems in their manufacturing processes.

Are Disposable Components a Green Solution?

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The US Food and Drug Administration issued a rule that clarifies its requirements for current good manufacturing practices for aseptic processing, water standards, and verifications standards.

Aseptic/Sterile Processing