Aseptic/Sterile Processing

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.
Oct 01, 2006
Pharmaceutical Technology Europe
UK science has an outstanding record and we remain strong internationally in terms of achievement, productivity and efficiency.
Oct 01, 2006
Pharmaceutical Technology Europe
In view of the nature of its complexity, it might be desirable to apply FDA's process analytical technology to lyophilization.
Sep 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Before formal cleaning validation programs were instituted, visual inspection was the primary means of determining equipment cleanliness. The use of visual inspection is still typically a component of a cleaning validation program and for routine inspections of cleaning effectiveness, but the use of visual inspection as a sole criterion for equipment cleanliness has not been successfully implemented as a valid approach for cleaning validation.
Jul 02, 2006
Pharmaceutical Technology
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.

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