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Market Reports
Environmental monitoring meets sterility testing
Better processes and continuous EM methods are practical steps to overcome the challenges involved with sterility testing. Andy Whittard of Cherwell Laboratories explains how to approach these activities to mitigate the risk of a process failure
Cleanroom garments: Risk focus meets quality by design
A holistic approach for cleanroom garment validation spends more effort at the outset of design phase and on design qualification. Milenko Pavičić and Thierry Wagner of DuPont explain
Biocidal Products Regulation: Cleaning-up the marketplace
Bioquell's John Chewins explains how to sourcing chemical products for biodecontamination compliant with the legal framework
Environmental monitoring: From sampling plan to data analysis
Axel Schroeder of Concept Heidelberg and Raphael Bar of BR Consulting analyse the steps to compliant EM monitoring ahead of the course EM Monitoring Data Management on 20-21 November hosted by ECA Academy in Barcelona
Joy McElroy | GMP Consultant
The US-based pharmaceutical manufacturing expert sets the record straight on quality assurance. “Quality is of utmost priority, and top-level management must understand this. We must teach GMPs to them,” she says
Opinion: Clothing solution for EU GMP Annex I
Only single-use cleanroom apparel will help sterile product manufacturers improve compliance with the new guidelines, says Franck Bureth of Kimberly-Clark Professional
B.Braun Medical: The journey to a compounding aseptic production unit
Paul Bradley reviews the 24-month design, build and validation process that led the company to expand its Sheffield facility with two new Grade B production rooms increasing capacity by 70%
How to design a cleanroom monitoring system
This guide to designing a GMP-compliant cleanroom monitoring system is the first of a series of four articles about monitoring systems covering design, installation and validation, maintenance, and data interpretation
Andrew Davies | Microgenetics
The Managing Director of biotech start-up Microgenetics is revolutionising microbiology with the use of machine learning and artificial intelligence to provide real-time analysis of environmental monitoring data
What is the scientific approach to cleanroom HVAC design?
Nigel Lenegan of Energy & Carbon Reduction Solutions answered this question at the Cleanroom Technology Conference 2019 and his presentation is now available online
Draft Annex 1: Cleaning and disinfection clarified
The preliminary version of the guidance for the manufacture of sterile medicinal products details core principles for cleaning and disinfection within a holistic contamination control strategy. Although a draft version, it would be prudent to plan validations with these core principles in mind. Contec's Karen Rossington explains
Coverage, buckets, and validation: The secret to mopping floor surfaces
Contec's Dave Nobile on the best practices to render consistent desired outcomes
HVAC cleanroom design calculation explained
Mecart's Charles Lipeles dissects the key considerations to factor in the drawing board
Guide to wash-in-place process in horizontal mixing systems
Modular solutions are proven to reliably fulfil any industry-specific requirements in the pharmaceutical, food, cosmetics, and chemical industries. Sebastian Steinkamp of Lödige provides a step-by-step guide to effective cleaning
Guide to energy-efficient cleanroom projects
New technology and design tools allow for delivering efficient and resilient manufacturing facilities without a cost premium. Matt Harris and Keith Beattie of EECO<sub>2</sub> explain
Debugging the effluent
Effluent decontamination systems are critical to the safe operation of a contained facility. Microorganisms can easily find their way into waste liquids and disinfectants are toxic, so what is the best way to manage it? Astell's Paul Birchmore explains
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Trending Articles
Harmonisation of Annex 1 and ISO 14644-1: A deeper look
Alexander Fedotov from Invar explains that the harmonisation of standards seems to be a driving force for setting particle limits and why this may not always result in logical scientific decision making
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Must cleanrooms always run at maximum airflow?
Mona Åkerholm and Hannu Nurminen from Elomatic walk through how companies should be rethinking cleanroom ventilation in the age of sustainability and soaring energy costs
EXCLUSIVE: The journey to create Staubli's new robot for pharmaceutical manufacturing
Julien Lora from Staubli talks to Sophie Bullimore about the development of the company's new robotic pharmaceutical solution, discussing the complexities of its launch as well as the pharmaceutical landscape it is launching into
Cleanrooms: What is the difference between clean-up period and recovery time?
The implementation of the new Annex 1, and references to the ISO 14644 family of cleanroom standards have raised questions around the "Recovery time" and the "Clean-up period." Nataša Štirn from Klimer and ICCCS Chair Conor Murray discuss
GMP Annex 1: Validation of disinfectants on cleanroom surfaces
Published in August 2022, for implementation in August 2023, Karen Rossington from Contec looks at the revised version of EU GMP Annex 1 expanded and clarified the regulatory requirements of cleaning and disinfection in life science cleanrooms
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