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Issue 48: 2022/Number Two

Main features

Filter leak testing with an LSAPC

W. Whyte

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Abstract

This article is the third of a short series of extracts from Bill Whyte’s new book Cleanroom Testing and Monitoring. Annex D, Filter leak testing with an LSAPC, 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. High efficiency filters are normally tested by the photometer method given in ISO 14644-3: 2019 and described in Chapter 8 of the book (as reproduced in CACR47). The LSAPC method, also given in ISO 14644-3: 2019 can be difficult to understand. Partly because of this, and partly because of the additional steps that are required, the method is not used, or is used incorrectly. Annex D was written with the object of giving a clearer and shorter explanation, to make the method less difficult to use.

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How AstraZeneca optimised Vapor Phase Hydrogen Peroxide gassing cycle development with Enzyme Indicators

Stephen Dawson, Miriam Guest

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Abstract

Vaporised hydrogen peroxide is used within the pharmaceutical industry as a surface decontamination tool, in both cleanrooms for the production of pharmaceutical products and in the quality control testing laboratories for the testing of such products. Efficacious decontamination is demonstrated in routine requalification traditionally using biological indicators. In this article, an approach to the application of data from enzyme indicators to cycle development is outlined. The case study highlights the ability to optimise an established cycle and provide a quantitative safety margin, providing robust assurance of process efficacy.

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Unknown knowns: Bringing it home – The final stages of a project

Andrew Watson

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Abstract

Cleanrooms are not built everyday. Often the people building them, and those having them built, are in virgin territory. The final stages of completing a project are where reality sets in and the success of the project can be in jeopardy. Whilst there is a lot written on this topic, those with previous experience are the ones to unlock the unknown knowns. In this article, the author, who has to be frank seen some things in his time, attempts to provide common sense and advice on how to plan for and approach the final stages of a project.

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Regulatory reflections

EU GMP and Annex 1: The new version

A paper prepared by Cherwell Laboratories Ltd

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Abstract

This paper sets out to highlight some of the principal differences between the new 2022 Annex 1 and the 2008 version. The new Annex places emphasis on a rationale for preventing contamination, the use of a quality risk management (QRM) approach, the development of a facility-wide contamination control strategy (CCS) and the deployment of a continuous monitoring approach for Grade A and B areas. Tables are used to illustrate the change in word-count for key words, grade level details for microbial contamination and grade descriptions, sample frequencies for viable air monitoring, aseptic preparation and vapourised hydrogen peroxide (VHP). Some of these are extracts from the old and new Annexes.

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A new challenge for quality experts – the Data Quality Concept

Maurizio Della Pietra

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Abstract

The role of quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other specialized functions. Creating a deeper quality connection between manufacturing and engineering has always been the aim of that growth. Little by little, quality became fundamental to every step of the pharmaceutical manufacturing process: changing from a silo concept to a more fluid one. Now, a new challenge is approaching. The fourth industrial revolution (Pharma 4.0^TM) is the beginning of the “Smart Facility” era, where digitalization and automation will combine to reach very complex applications and life cycles. In this brand-new framework, Quality Experts will face the challenge of rethinking their roles and redesigning the Quality Systems of their pharmaceutical companies to be based on the concepts of Data Quality.

Keywords: Data Quality; Holistic; Digital Maturity; Data Maturity; EVO 2; Pharma 4.0^TM

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