Market Reports

Challenging disinfectant residues as per GMP Annex 1

Karen Rossington of Contec analyses commonly used cleanroom disinfectants to shed light on the best approach to tackle residues that are left on surfaces

Cleanroom technology for the IVF industry

<i>In vitro</i> fertilisation is a process that mimics nature and as such, the industry requires state-of-the-art facilities to control environmental conditions and prevent contamination of the “product”. Giles Palmer explains

Cleanroom Technology Conference expands to Singapore

In addition to the big event in Birmingham, UK, there will now be a conference for those in the exploding market in Singapore

Medical cannabis made in Italy

Dr Fabio Di Francesco, a compounding pharmacist based in Rome, describes how cannabis is used in various dosage forms and the challenges ahead

Middle East market report: Oil-rich countries switch it up

The United Arab Emirates (UAE) and Saudi Arabia are top-tier economies in the Gulf turning to pharma and hi-tech industries to wean off lacklustre oil demand

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

Guide to wireless dataloggers for thermal validation

New wireless dataloggers deliver accurate thermal mapping with time-saving benefits. Chris Maughan, MD of Thermal Compliance, explains

Passivation: An extra layer of protection for critical equipment

The cleaning process that removes iron from a surface layer of stainless steel alloy can play a pivotal role in biocontamination prevention. Astro Pak experts Daryl Roll and Dr Brent Ekstrand explain

Review: Cannabis Europa 2019

Scientists, businesspeople and politicians backing the regulation of medical and recreational cannabis have taken the stage of Southbank Centre this week to discuss research and business opportunities

Trending Articles

  1. A review of innovations in sustainable cleanroom operations Nash Mader from Instant Cleanroom Solutions lists the notable sustainability trends and innovations in action in cleanroom projects in 2025
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    Sporicides: Optimal criteria for cleanroom users In addition to basic chemicals and formulation, there are other criteria that contribute to making something a sporicide. Tim Sandle, in partnership with Ecolab Life Sciences, explains what you need to know
  3. Tips for particle concentration compliance under ISO 14644-1:2015 Apply these six steps to make your cleanroom fit for the new standard, says Hasim Solmaz, Lighthouse Worldwide Solutions
  4. 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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    Annex 1 and “first air”: What is it and how is it used? First Air as a concept is a major update in the new Annex 1 to continue global harmonisation of regulatory standards, but what is it and how is it used in the new document to improve clarity and compliance? Josh Russell, VP of Sales and Marketing at AST discusses

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Pharmig Annual Pharmaceutical Microbiology Conference

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