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Issue 33: January 2018

Main feature

Taming the Tyrannosaurus of validation

Tim Coles, Helen Hale

Abstract →

Abstract

In this paper, the authors argue that the process of validating equipment in the pharmaceutical industry has become so complex and unwieldy that it may actually have become counter-productive. Such large volumes of documentation are produced that the critical test data can be lost in a welter of largely irrelevant information. It is suggested that validation needs to be rationalised into a generally-agreed format, and slimmed down to a more effective structure. The validation process could be based on the Requirement Traceability Matrix (RTM) which follows each point in the URS through to closure. The universal log-jam of document approval has to be addressed, perhaps by reducing the numbers of people required to review and approve protocols. The layout of protocols could be more standardised but above all, validation needs to take stock of what is central to the process of ensuring product quality and operator safety.

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Understanding Particle Counter technology, the risks of particle count data integrity and the importance of ISO 21501-4 calibration

Jason Kelly

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Abstract

Airborne Particle Counters are widely used in Cleanrooms to monitor for sign of cleanroom air contamination and in most cases the particle count data is used to make critical process decisions. Today’s Portable particle counters have come a long way with the advent of laser diode technology. Older generation cumbersome helium neon lasers also referred to as HeNe’s have been phased out in favor of smaller, lighter and feature packed new technology Portable Particle counters with touchscreens and automatic certification reports that comply to many of today’s Cleanroom Certification standards. In effect these devices have so much computing technology embedded that they really need to be validated to ensure they meet your process requirements. With so much focus on data integrity and the FDA’s ALCOA approach this paper takes a deep dive into Particle Counter technology and will help to assist decision makers in making informed choices when considering which option/model is best for their process when data integrity is of paramount importance to them. It is important to also acknowledge the advantages of an ISO 21501-4 calibration. ISO 21501-4 is a major particle counter calibration standard and one of the most complete guidelines and it is important that particle counters are calibrated to meet this standard as this calibration allows for better accuracy and reliability which in turn mitigates data integrity issues by verifying that the count data is as accurate as can be. It is therefore important to understand the relationship between ISO 14644-1:2015 and ISO 21501-4:2007. Overall the objective of this article is to increase your knowledge of Particle Counting technology as particle counters play such an important role in the front line of defense against contamination in your Cleanroom.

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Profile

Meet Dr Tae Yun Kim, CEO of Lighthouse Worldwide Solutions

Agape Kim

Regulatory reflections

Draft revision of EU GMP Annex 1 Manufacturing of Sterile Medicinal Products for targeted consultation: implications for cleanrooms

Tim Sandle

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Abstract

Annex 1 of EU GMP has set the standard for sterile products manufacture for over 25 years. A new draft of the Annex was issued in December 2017 for a targeted stakeholder consultation. Given that the last major update to the guidance was almost ten years ago, considerable changes have taken place in terms of technology (the increased use of RABS and isolators, for example) and contamination control philosophies. This article assesses the primary changes set out in the draft Annex, with a focus on cleanrooms and cleanroom technology.

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Exhibition and conference report

Cleanzone 2017: focus on innovation

Richard Roberts

Life-lines

News

Cleanzone 2017: Large increase in visitors strengthens the trade fair's international and interdisciplinary position

Contec HydroPure now available in a convenient point-of-use canister system

Crowthorne Group completes 3rd acquisition in 12 months

Positive start to 2018 for Clean Room Construction

Spetec cleanroom technology for any workplace in industry and research: FBS and CleanBoy® laminar flow units

Cherwell appoints new Engineering Manager

Events and Training courses