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

A comparison of conventional cleanrooms, restricted access barrier systems, and isolators, shows the benefits of using isolators in high-potency drug manufacturing.

Comparison of Conventional Cleanrooms, Restricted Access Barrier Systems, and Isolators

Henning Gieseler, PhD, works in the Department of Pharmaceutics at the University of Erlangen, Erlangen, Germany 91058. tel. +49 9131 85 29545, gieseler@freeze-drying.eu.

Tony Kramer works at the Ecolab Research Center in Eagan, Michigan.

Stefan Schneid works in the Department of Pharmaceutics at the University of Erlangen in Erlangen, Germany.

Cycle design and robustness testing using advanced process analytical technology.

Peer-Reviewed Technical Note: Quality by Design in Freeze-Drying

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

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

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.

Aseptic processing has advanced over the past several decades, yet the pharmaceutical industry is still accepting of its limitations, particularly as it relates to human intervention as a source of contamination. The authors explain the importance of further diminishing the role of operators in aseptic processing and the approaches and technologies needed to achieve that goal.

The Truth about Interventions In Aseptic Processing

There is a growing need for patient-compliant dosage forms within the cancer therapeutics and biotechnology areas. Ease of administration, enhanced therapeutic efficacy, and reduced side effects are factors that differentiate drug delivery products from conventional dosage forms and provide a competitive advantage. This article reviews salient trends in the parenteral drug delivery sector within the realms of a changing regulatory environment, drivers to growth, and recent advances in this field. Challenges associated with bringing parenteral drug delivery concepts to commercialization are discussed.

Drug Delivery Trends for Parenteral Therapeutics

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing. 

Manufacturing, Parenterals and Injectables