Latest in Regulatory

Microbiological monitoring: Adapting to new rapid methods regulatory demands

Dr Wan Li Low from Cherwell takes a look at the shift towards Rapid Microbiology Methods (RMM) and their validation

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Showcase your company: Be a part of the #1 Cleanroom Conference in the UK

Get your brand in front of key decision-makers at the Cleanroom Technology Conference on 21 & 22 May 2025
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How to successfully make the transition to gassing isolators

Automated biodecontamination of the interior of isolators is the direction of manufacturing following the release of EU GMP Annex 1 in 2023. But how do you make the transition? Matt Stubbs from Envair discusses

UPDATE: US Pharmacopeia makes comments public on endotoxin testing overhaul

The USP has published the comments the organisation received in response to the addition of non-animal derived endotoxin testing methods, as well as an FAQ page on the issue

Considerations in navigating radiopharmaceutical facility design

Given the highly individualised nature of radiopharmaceutical products, cleanroom design teams have a lot of specific requirements to take into account. Andy Tyner from SMRT Architects & Engineers discusses

Nortek Air Solutions CleanSpace relaunches SERVICOR for modular cleanrooms

Nortek Air Solutions CleanSpace shared with Cleanroom Technology how SERVICOR for modular cleanrooms, complies with ANNEX 1 requirements, as it was relaunched to meet industry demands for cleanrooms that can achieve the required filtration levels

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

Manufacturer Fermenta Biotech receives certificate of GMP compliance for facility

Fermenta Biotech has received a certificate of GMP compliance from the Competent Authority of Germany for its Active Pharmaceutical Ingredient manufacturing facility in India

Case study of an integrated continuous biomanufacturing facility cleanroom build

Abu Bhargava from construction expert Skanska discusses how the company converted a 140,000 sqft half-completed space into an integrated continuous biomanufacturing facility that would meet cGMP requirements

Catch up on our free Cleanroom Technology Roundtables

Discover what experts consider to be the hottest topics across the contamination and control industry, from pharmaceuticals to HVAC and beyond

Latest posts in Regulatory

New Dastex CEO Linda Vereycken talks about her next moves

The incoming CEO at garment manufacturing expert Dastex talks about the next steps following the Riverside, Vita Verita and AET acquisitions, as well as what she is noticing in the cleanroom consumables industry of today
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Upperton’s GMP manufacturing facility passes MHRA inspection

The GMP manufacturing facility of Upperton Pharma Solutions took 18 months to build, commission, validate and approve

Micronclean releases new range of Annex 1 compliant rotational disinfectants

Micronclean has developed two new sterile disinfectants Alpha Plus and Beta Plus with patent-pending technology to meet the rotational disinfectant requirements of Annex 1

Fraunhofer IPA certifies TOX servo presses for ISO Class 5 cleanrooms

TOX’s ElectricDrive Core servo presses for shaping metal have been certified as ISO Class 5 cleanroom suitable

The difference between an ISO 17025 certified laboratory and an ISO 9001 one

The team at QSGroup, an Italy-based contamination control specialist company, go through the main differences between an ISO 17025-certified laboratory and an ISO 9001-certified laboratory

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

EU GMP Annex 1 compliance: should you get new equipment or upgrade?

Buy a new machine or upgrade the existing equipment? In light of Annex 1, pharmaceutical manufacturers and contract manufacturing organisations are facing this question more than ever. Steffen Mueller discusses the solution Syntegon worked on with AJ Vaccines

Environmental monitoring expert Pharmagraph launches portable microbial air sampler

Pharmagraph has launched the EN 17141:2020 compliant portable air sampler model
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USP < 797 > Viable Air and Surface Sample Reports: 3 common errors

Sterile compounders often make errors in testing and reporting, this can be in misrepresentation of processes, incubation times, and even the reality of 0 as a reporting number. Abby Roth from Pure Microbiology talks through 3 common errors

Novartis and Sandoz support founding of Slovenian Cleanroom Society

The professional association, Slovenian Cleanroom Society, has been founded to serve the cleanroom technology and contamination control sector in the country

Ready, set, submit: MSL advocates for swift action on BPR dossiers for quats

As the 1 July 2024 deadline for the Biocidal Products Regulation dossiers for quaternary ammonium compounds approaches, the team at MSL discuss why timely action is essential to staying compliant

Gekatex Group’s new facility in China gains ISO 14001 certification

The manufacturer of consumables for surface preparation and protection has been awarded a 14001 certificate

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The three musketeers of pharmaceutical quality control

GMP, GAMP5, and 21CFR11 explained

A guide to cleanroom wall systems

Discover the best wall panel options for your cleanroom’s performance and compliance needs

The importance of liquid particle counting in public health and safety

Ensuring the purity of water, pharmaceuticals, and food products through precise contamination monitoring

The importance of ultra pure water in critical industries

How advanced tools maintain purity for semiconductors and pharmaceuticals

Types of cleanrooms in various industries

Discover the critical cleanroom solutions Precision Environments provides across sectors like semiconductor, biotech, and medical device manufacturing.

Cleanroomshop launches a brand new website

New features and improved design enhance customer experience

Cleancube multi: Guardtech’s container facilities support NHS aseptic pharmacies

Award-winning mobile cleanrooms offer fast, flexible solutions for facility upgrades

Steriline Asia returns to CPHI & PMEC India with technology and process advancements

Focus on sustainable innovation and regulatory alignment for the local market

Why build ISO 7 cleanrooms for PV generation one after another?

Increasing demand for renewable energy drives the need for more cleanroom capacity in photovoltaic generation

AdvanceTEC boosts role in NIST's semiconductor innovation with CHIPS Act project

Strategic partnership advances U.S. innovation in semiconductor and nanotechnology

AdvanceTEC selected by Repeat Global CDMO for large-scale biotech investment

Strategic partnership to drive innovation in biotech manufacturing

Introducing new glass branding from PBSC

Modern glass door design elevates cleanroom aesthetics and functionality

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