Manufacturing

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.

Articles

The author clarifies the definition and objectives of overkill sterilization for steam sterilization cycles. Current sterilization practices are reviewed and the validation difficulties associated with the various definitions of overkill sterilization are explored.

Understanding Overkill Sterilization: An End to the Confusion

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

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

Interphex2007, New York, NY (Apr. 25)-As manufacturers prepare for processing more-potent compounds, they seek effective clean-in-place (CIP) and wash-in-place (WIP) design systems.

Importance of Clean-in-Place Design Planning Emphasized

Manufacturers use various techniques to transfer sterile liquid. Some methods, however, cannot accommodate disposable equipment, and others cannot transfer through barriers. This article describes a new approach for aseptic fluid transfer that was developed to provide a high-quality aseptic connection and simplify passage through a wall. The authors discuss the product-qualification results for the approach, which show that the technology and its various components meet pharmacopeial product-qualification requirements.

Qualification Results of a New System for Rapid Transfer of Sterile Liquid through a Containment Wall

Agawam, MA (Mar. 26)-Contract manufacturing and testing laboratory Microtest signed a manufacturing deal with Antisoma to produce AS1411, a new drug being developed for the treatment of various cancers.

Microtest and Antisoma Form Manufacturing Pact

Johannes Rauschnabel is a director of process engineering and a coordinator for barrier systems and the PharmaLab at Bosch Packaging Technology.

Filling machines often are installed in sterile rooms and separated by isolators to prevent contamination. These methods have certain drawbacks, including making interventions more difficult. Restricted-access barrier systems are an alternative that ensures sterility and facilitates interventions.

The Advantages of Restricted-Access Barrier Systems

Finding a CMO partner will take time and an incorrect choice that leads to changing the CMO is financially very painful.

Outsourcing aseptic fill and finish

Over the past decade, disposable technologies have become a reality in biotech processes. The use of disposables in research and manufacturing allows high flexibility.

Disposable bioreactors based on wave agitation technology

Clean rooms are critical areas in bio/pharma facilities, and it is essential that users are responsible for their care and upkeep, and familiarize themselves with the relevant regulations.

Keeping clean rooms compliant

Glasses are important when operating in a sterile environment, and it is necessary to ensure that they will stand up to repeated sterilization processes without introducing contaminants. The glasses were subjected to numerous steam sterilization cycles to assess durability and microbial reduction. Results showed that the glasses most widely available on the market have been refined by the manufacturer to satisfy pharmaceutical customer needs by withstanding repeated sterilization cycles and minimizing contaminating particle release.

Aseptic/Sterile Processing