Clean Air and Containment Review





Editor: John Neiger
Publisher: Euromed Communications
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Journal contents list

< Issue 50 | Issue 51

Issue 51: 2024/Number Two

Main features
Classification of air cleanliness by particle concentration according to ISO 14644
W. Whyte
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Abstract

This article is the fifth of a short series of extracts from Bill Whyte's new book Cleanroom Testing and Monitoring. Chapter 12, Classification of air cleanliness by particle concentration according to ISO 14644-1, 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 previous chapter, Chapter 11, Airborne particle counting with an LSAPC, was published in CACR49. 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.

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The d50 cut-off size of microbiological impaction air samplers: derivation of simplified expressions
Bengt Ljungquist and Berit Reinmüller
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Abstract

The latest 2022 revision of EU GMP Annex 1 1 introduced the requirement to qualify particle counters, including sampling tubing (ref. Annex 1, Clause 5.9). It is therefore now necessary to assess particle losses in sampling in order to understand the quality of particle measurements in the context of monitoring or of classification. This requirement of Annex 1 is supported by the release of ISO/TR 14644-21 2 – Part 21: Airborne particle sampling techniques which brings clarification to the application of airborne particle sampling techniques.

The author’s company has been working for several years on the validation of sampling lines to offer particle deposition measurements which are metrologically traceable and accurate in terms of the theoretical equations which control these deposition phenomena. The results presented in this article demonstrate that an experimental approach in the laboratory, by modelling a real line, makes it possible to quantify the loss of aerosol and to optimize the overall geometry of sampling lines before implementation

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Selection of microbiological swabs for cleanroom monitoring: design considerations
Tim Sandle
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The range of sampling methods for the environmental monitoring of cleanrooms has included swabbing for several decades. It has long been accepted that the use of swabs leads to a relatively low recovery of microorganisms from surfaces. However, the recovery from swabs can be improved by selecting flocked swabs over plain swabs and with fine tuning the method, including the testing of the swab recovery fluid. This article presents data showing the superiority of flocked swabs and considers how different surface materials affect microbial recovery.

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Pharma 4.0TM and how it impacts EU GMP Annex 1 CCS (Contamination Control Strategy)
Jason Kelly
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Abstract

Pharma 4.0TM represents a transformative shift in the pharmaceutical manufacturing landscape, particularly in the context of aseptic processing of sterile products. It is driven by the integration of advanced digital technologies to enhance efficiency, compliance, and quality in drug manufacturing. The latest revision of the EU GMP Annex 1 emphasizes a stringent Contamination Control Strategy (CCS) and incorporates Quality Risk Management (QRM) principles, highlighting a shift towards risk-based approaches and real-time environmental monitoring. This paper explores how Pharma 4.0TM facilitates a robust CCS by leveraging real-time data collection, digital maturity, and data integrity within pharmaceutical operations. Enhanced use of digitally enabled tools such as particle counters and air samplers, and advanced data analytics enables better decision-making, ensures compliance with regulatory standards, and supports continuous manufacturing. By fostering an interconnected pharmaceutical environment, Pharma 4.0TM not only aims to safeguard product quality and patient safety but also propels the industry towards a future where digital integration ensures seamless operation and superior product integrity.

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Understanding the route to compliance with EU GMP Annex 15: Qualification and Validation
Toni Horsfield
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This short article, which is based on a Webinar by Gordon Farquharson and a blog by the author, introduces the principles of qualification and validation as described in EU GMP Annex 15. The key requirement is for the Validation Master Plan to be a living document with a robust change control protocol. Two flow diagrams illustrate the workflow through the validation stages of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) and a list is given of recommended tests for cleanrooms and clean zones.

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