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.
In the pharmaceutical and biotechnology sectors, the clean room business is flourishing. Accounting for approximately 25% of the world's clean room expenditure, Europe's drug manufacturing industry is using these facilities to produce an increasing amount of biologics and biopharmaceuticals, and meet the strict legislative requirements for aseptic processing. This article reviews the current and future state of the market for clean rooms in Europe and comments on their applications.
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.