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May 01, 2009
A novel cleanroom apparel design incorporates modern concepts to help minimize contamination. Take a tour of the design.
January 25, 2008
In light of the rising price of stainless steel components and facility construction, pharmaceutical companies are increasingly using disposable components and systems in their manufacturing processes.
October 02, 2006
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.
May 01, 2005
Study results show that the state of a cleanroom clothing system–new or much used–influences the protection efficacy of the system.
April 02, 2005
The authors argue that chlorine dioxide (CD) is a safe and effective decontaminating agent that can be used for challenging applications.The effectiveness of CD gas for sterilizing complex isolator systems is studied.
November 02, 2004
A discussion of the validation and operation of two commercially available vapor-phase hydrogen peroxide decontamination systems is presented, based on a hands-on examination of both systems.
March 01, 2003
When planning the installation of a new stainless steel process pipeline, it is important to understand the significance of using the best possible materials and techniques to ensure it is clean when installed. This article examines the factors that must be considered when planning and constructing a new process line.
February 01, 2003
The influence of containment classification in facility design cannot be underestimated. It can, for example, determine the extent of the design process and the level of equipment needed to safeguard human life and the surrounding environment. This article discusses factors that should be considered when planning such a containment facility, including material flow, process equipment and regulatory guidelines.
Testing sterilizing grade filters using integrity testers has become a standard method in biopharmaceutical production and quality assurance. In accordance with international regulations and recommendations, these filters should be tested before and after filtration. For these applications, a variety of automatic integrity testers is available. Currently, there are two groups of devices that are used to conduct validated testing procedures, such as the bubble point test, the diffusion test, and the water intrusion test (WIT) and water flow test (WFT). Whereas one group of devices relies on the principle of flow measurement, the other group is based on pressure drop measurements. The following report compares the accuracy of the two test methods, using the WFT as a reference.
Closed and disposable sterility testing devices reduce the risk of false positive results during sterility testing. To further prevent such results, some pharmaceutical manufacturers use the device inside a sterility testing isolator, which is decontaminated using sterilant gases or vapours. In this study, closed, disposable sterility test devices were exposed to two 90 minute vaporous phase hydrogen peroxide (VPHP) decontamination cycles within a sterility testing isolator and tested for device integrity, bacteriostasis/fungistasis and non-volatile residue content. The results showed that the VPHP used to decontaminate the isolator before sterility testing did not affect the device.