Clean Air and Containment Review

Editor: John Neiger
Publisher: Euromed Communications
Site design:
Fourwest Media

Journal contents list

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Issue 39: Summer/ 2019

Main features
Clean build protocols – concepts and considerations
Andrew D. Watson
Abstract →

A clean build protocol (CBP) is an essential component of a cleanroom construction project. This paper provides guidance on how to develop and implement a CBP in order to deliver a cleanroom that can successfully achieve its designated ISO classification.

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Monitoring and controlling of vaporized hydrogen peroxide bio- decontamination cycles
Sanna Lehtinen
Abstract →

This article starts by describing the advantages of using vaporized hydrogen peroxide for bio-decontamination where highly resistant pathogens including bacterial spores might be present. The advantages are its efficacy at room temperature, material compatibility, lack of toxic residue and the relative ease of validation. Several commercially available measurement technologies are described and compared and inline measurement sensors are compared with chemical indicators (CIs, biological indicators (BIs) and enzyme indicators (EIs). The article reports on the results of asking attendees at a Vaisala webinar: "How do you use H2O2 ppm measurement today?" and "What are the most important sensor features. Following on from this, the article examines the benefits of using sensors for monitoring and controlling bio- decontamination processes.

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Risk and science-based validation of cleanroom garments
Milenko Pavicic and Thierry Wagner
Abstract →

Important quality attributes of cleanroom garments that to worn during the manufacture of sterile medicines include: cleanliness; sterility; particle and microbial filtration efficiency; durability; usability; and comfort. Important risk factors related to cleanroom garment systems include gowning processes and related activities, such as laundering, packing, sterilization, repairs, storage, handling and logistics, as well as change management. Because many factors contribute to the overall quality, adequacy and suitability of cleanroom garment systems, a thorough and focused validation of cleanroom garments is critically important.

After providing a review of current and emerging regulations and standards, this article proposes a risk- and science-based quality-by-design approach for the development, implementation and validation of sterile cleanroom garment systems. With this approach, more effort is spent at the front-end during the design phase as well as during design qualification. This will lead to designed-in risk reductions; enhanced scientific knowledge on selected technical solutions; and better awareness of limitations and residual risks. As a result, there should be fewer issues during cleanroom qualifications and process validations, leading to more effective routine operations as well as improved patient safety. The proposed approach, if implemented correctly, is not only the correct strategy to effectively control contamination risks related to people, but also an adequate response to the latest regulatory requirements.

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Conference review
Review: Cleanroom Technology Conference 2019
Murielle Gonzalez
Events and Training courses