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Issue 47: 2022/Number One

Main features

Multiple users in a Biosafety Cabinet compromise containment

Kara F. Held and Robert Thibeault

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Abstract

Biosafety Cabinets (BSCs) are primary containment devices used to help reduce the risk of contamination to the work, the worker, and the surrounding environment. These devices have rigorous testing and certification to ensure their functional capabilities of contaminant reduction according to NSF International Standard 49 but these BSCs are always tested empty without users present in front of them for a functional baseline. However, BSCs are never used in this manner. There are known commonly performed actions within BSC operation that may compromise BSC containment. Here, we address one of these BSC myths, specifically whether two or more people can work within one BSC and still maintain their intended capacity for particulate containment as measured through visual smoke demonstration and NSF International Standard 49 Microbiological Aerosol Testing.

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Cleanroom Testing and Monitoring – Chapter 8: Filter installation leak testing by the photometer method

W Whyte

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Abstract

This article is the second of a short series of extracts from Bill Whyte’s new book Cleanroom Testing and Monitoring and is reproduced here with the kind permission of the author, Bill Whyte, the publisher, Euromed Communications, and the owner of the copyright, the Cleanroom Testing and Certification Board – International (CTCB-I). The objective in publishing these extracts is to give readers a flavour of the content and depth of the book which is recommended as a comprehensive textbook and an essential reference for cleanroom managers, cleanroom test engineers, cleanroom service engineers, cleanroom designers and specifiers and anybody who is concerned with cleanrooms. All too often testing and monitoring are insufficiently considered until an installation is physically complete. If you design and build an installation to achieve a certain performance, it is essential that you understand and plan at an early stage for how that performance will be verified and monitored throughout the life of the installation.

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Comparison of radiation methods for the sterilisation of cleanroom items

Tim Sandle

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Abstract

Many items entering cleanrooms, especially aseptic processing facilities, are required to be sterile. Sterilisation by an ionising radiation source is the most common way of achieving sterility and is used for cleanroom garments as well as for plastic items intended for single-use, such as sampling containers, aseptic connectors, biocontainer bags, and mixers. For several decades, Gamma radiation was the standard method for the irradiation of cleanroom consumables. In more recent years, both electron beam and X-rays have been added as ionising radiation methods for the processing of cleanroom items. The increase in use of these latter technologies is evidenced by change control notifications from cleanroom product companies indicating a move away from Gamma radiation to these alternative radiation sterilisation methods (primarily electron beam but sometimes X-rays). The shift away from Gamma is because the process of radioactive decay utilises costly isotopes which require periodic replacement (typically five years) and because international transport for radioactive materials has become far more difficult.

This article looks at the similarities and differences between the three types of irradiation sterilisation technologies commonly used to irradiate items going into the cleanroom: Gamma, E-beam, and X-ray.

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