Latest in Regulatory

ABN Cleanroom Technology launches rental solution for production of cytostatics for Belgian hospitals

Amidst new pharmaceutical inspection regulations, ABN Cleanroom Technology has launched a turnkey rental solution of cytostatics for Belgian hospitals called CYTONIX

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Who will lead the next cleanroom breakthroughs?

As cleanroom technology evolves, so does the need for new perspectives. The Cleanroom Technology Conference 2026 invites innovators and industry experts to share new ideas,...
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Amkor breaks ground on $7bn semiconductor campus in Arizona

The semiconductor packaging and test services provider has begun to expand cleanroom and testing capacity as US chip manufacturing ramps up

TriCelX gains FDA registration for Texas cell manufacturing facility

The new ISO Class 7 cleanroom facility in Frisco has reached a crucial step in regulated regenerative medicine manufacturing

Sustainability in the cleanroom: A scientific approach

Stefaan Vanhalle from STAXS discusses the ways to reduce a cleanrooms environmental footprint, as well as common traps that companies fall into in this effort

BSI launches long-awaited inclusive PPE standard

The British Standards Institution has launched a new standard, BS 3041, to address the persistent issues with PPE fit in today's workforce
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Market report: Cleanroom goggles in North America

Canada-based Klaritex’s CEO, Atif Sarfraz, talks to Sophie Bullimore about meeting the challenges and trends in the cleanroom goggle market in North America

Single-use vs permanent transfer solutions: An overview

Isaac Giesen from CRL weighs up the options available to manufacturers for material transfer based on upfront cost, labour, flexibility and target market

BES delivers modular QC laboratory in southwest England for global wellness leader

The 1,100 sqm facility combines modular construction, bespoke engineering, and sustainability

Today's highlights: Day 1 at the Cleanroom Technology Conference 2025

Talks have begun and exhibitor stands are open at this year's event. Almost 400 people are gathered in Birmingham, with attendees from Micronclean, Guardtech, AstraZeneca, Kingspan and more

Latest posts in Regulatory

Stem cell cleanroom requalification takes three days

CAT Group has finished its requalification of a 30 sqm cleanroom at the Joint Stem Cell and Immune Laboratory in the University Hospital Tübingen

BioClad awarded patent for antimicrobial modular wall plumbing unit for hospitals and cleanrooms

UK-based hygienic wall cladding expert BioClad has been awarded a patent for its  “Integrated Plumbing System Apparatus and Method of Manufacture”
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What does EU GMP Annex 1 classification mean for cleanroom furniture and hygiene protocols?

In this article, Michelle Locke, Product and Marketing Manager at Teknomek, takes a closer look at what EU GMP Annex 1 means for cleanroom furniture and hygienic protocols
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A question of quality: Implementing quality by design principles

Jason Rossi from AST discusses how a systematic approach, “Quality by Design”, is used to design and develop of drug product manufacturing environment that prioritises product quality and QRM principles

Nelson Labs to double cleanroom capacity at US headquarters

The laboratory services provider has started a major expansion of sterility assurance facilities to meet rising global demand and stringent EU GMP Annex 1 standards
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The role of biocide compliance in cleanrooms

Peter Thistlethwaite from MSL Solution Providers explores the role of biocide regulations in maintaining the safety of cleanroom environments

EMA proposes revision to GMP guidelines for ATMP production

The 2023 revision of Annex 1 has left Part IV outdated, missing key references to QRM, CCS, modern technologies, and barrier systems

Austar delivers compliance consulting for major high-tech insulin manufacturer

With growing global demand for advanced diabetes treatments, an insulin manufacturer has partnered with Austar to strengthen its regulatory compliance and accelerate international clinical trials
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President Trump signs order for “regulatory relief” for domestic pharmaceutical manufacturers

The US President has signed an executive order to direct the FDA to review current regulatory procedures, such as by reducing inspection frequency

Camfil welcomes updated EN 16798-3 air filtration standard

EN 16798-3 standard sets new air filtration requirements for non-residential buildings, aligning with the World Health Organisation air quality guidelines

EU wastewater directive triggers demand for advanced cleanroom solutions in pharma manufacturing

The new EU directive poses cost and compliance challenges for pharma but also creates opportunities for the cleanroom industry

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Sterility testing | USP 795 & 797 revisions

In this episode, the discussion is about the sterility test requirements

Facility design and construction requirements | USP 795 & 797 revisions

Join Eagle Analytical for the latest installment of its ongoing series on USP 795 and 797 revisions, where it will delve into the topic of facility design and construction...

Testo Saveris brings comprehensive pharma measurement system to CPHI 2025

Fully automated monitoring system delivers reliable data across the pharmaceutical supply chain

Germfree | Carol Houts

Carol Houts talks to Sophie Bullimore about the US-based modular expert’s expansion into stick-built cleanrooms, how the company is responding to US policy shifts, and...

Airkey delivers 450 sqm modular cleanroom for Abu Dhabi pharmaceutical facility

The self-supporting cleanroom has passed GMP validation, supporting capsule production

Filter manufacturer maintains official seal of approval for health and safety

Inspectors from health and safety standards body BSI have praised a process filter maker’s ‘thorough and well-organised approach’ to workplace safety management

Qualification master plan: a strategic tool for GMP project success

Why an effective QMP is essential for compliance and quality assurance

Performance qualification: ensuring cleanroom compliance under real conditions

How PQ validates cleanroom performance for GMP and regulatory standards

Inivos unveils ProXcide Mini: the future of small-chamber bio-decontamination

From biosafety cabinets to isolators, the ProXcide Mini offers reliable bioburden reduction in spaces others can’t reach

Understanding the difference between cleanroom qualification and validation

Each serves a different purpose in ensuring your controlled environment performs as required, and both are vital in meeting compliance expectations

Angstrom launches life science business unit to support specialised cleanroom needs

New brand focuses on pharmaceutical and biotech sectors with tailored regulatory expertise

Ecolab Life Sciences launches new purification resin for antibody manufacturing

Purolite AP+50 supports cost-efficient, high-performance bioprocessing at scale

Featured companies

STERIS Life Sciences is a global leader in contamination control. Our comprehensive, scientifically validated portfolio of products and services is designed to meet the diverse... EECO2 is a leading global provider of researched, tested and proven efficiency solutions for the pharmaceutical, biotech and other high-tech industries. FMS (Facility Monitoring Systems Ltd) provides airborne particle counters, Environmental Monitoring (EM) systems, Far-UVC decontamination solutions, contamination control... MSL Solution Providers (MSL) is a microbiological testing laboratory, specialising in efficacy testing of biocides and disinfectant products used in a wide range of...
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