Aseptic/Sterile Processing

May 01, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
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.
May 01, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
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.
Apr 25, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
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.
Apr 02, 2007
Pharmaceutical Technology
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.
Mar 30, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
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.
Mar 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
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.
Mar 01, 2007
Pharmaceutical Technology Europe
Finding a CMO partner will take time and an incorrect choice that leads to changing the CMO is financially very painful.
Feb 01, 2007
Pharmaceutical Technology Europe
Over the past decade, disposable technologies have become a reality in biotech processes. The use of disposables in research and manufacturing allows high flexibility.
Nov 01, 2006
Pharmaceutical Technology Europe
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.
Oct 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
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.
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