Manufacturing

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.

Articles

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

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.

FDA Issues Rule to Clarify GMP Requirements for Aseptic Processing

Motonari Deguchi works in the Microbial Control Department at Shibuya Kogyo Co., Ltd. in Kanazawa, Japan.

Mayumi Maruyama works in the Microbial Control Department at Shibuya Kogyo Co., Ltd. in Kanazawa, Japan.

Tomoo Matsuoka works in the Microbial Control Department at Shibuya Kogyo Co., Ltd. in Kanazawa, Japan.

This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.

The Application of Robotics to Aseptic Environmental Surface Monitoring

Sterile liquids are frequently transferred during the processing of sterile liquid drugs such as injectables or ophthalmic drops. Several types of transfer can be performed, each requiring a validated method to ensure the desired sterility-assurance levels are achieved.

A new system for the rapid transfer of sterile liquid through a containment wall

Irradiation is an established method of sterilization for pharmaceutical products. Radiation sterilization can be achieved with gamma rays, electron beams, and X-rays. Each of these techniques has its advantages and disadvantages. The author describes these methods, the ways to find the correct sterilization doses, and the regulatory and safety concerns about irradation sterilization.

Radiation Sterilization of Parenterals

Validating the sterilization process is extremely important in pharmaceutical manufacturing. The authors explore different types of sterilization processes and discuss the importance of finding the worst-case positions of loads or equipment to be sterilized and the worst-case conditions for each sterilization cycle. Biological indicators (BIs) can be used to simulate worst-case scenarios and determine the effectiveness of a particular sterilization process.

A Risk-Based Approach to the Use of Biological Indicators in the Development and Control of Steam-Sterilization Processes

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.

Theodore H. Meltzer is principle of Capitola Consultancy.

Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the integrity-test specification established during filter-validation studies.

The Importance of Pre-Use Integrity Testing in Sterilizing Filtration

A biological indicator (BI) measures the effectiveness of the sterilization process to which it is subjected. Factors such as the test organism, the packaging, the culture material, and the test system all influence a BI's resistance. Carrier material is an often-overlooked factor that also influences BI resistance. The authors examine various solid and liquid carriers, describe their properties, and investigate how they influence BI resistance.

Aseptic/Sterile Processing