Latest in Regulatory

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

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A deep dive into the 2025 Cleanroom Technology Conference agenda

The agenda and networking opportunities make the Cleanroom Technology Conference a can't-miss event, you'll have the chance to connect with key stakeholders, suppliers, and...
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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The 2023 revision of Annex 1 has left Part IV outdated, missing key references to QRM, CCS, modern technologies, and barrier systems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

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

Moderna's UK facility receives key regulatory approval to begin mRNA vaccine production

Moderna secures MHRA licence for UK manufacturing facility, paving the way for British-made mRNA vaccines in 2025

ABC Transfer lands first ULTRA order

ABC Transfer has secured the first order for its new ULTRA gloveless transfer system from a major European biopharma manufacturer
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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

EPA accepts new Arxada sporicidal disinfectant

EPA registration signifies that the product and its claims have been reviewed and approved by EPA

The new challenges in aseptic manufacture

Aseptic medicinal product manufacturing has advanced recently in regulations and technology, impacting pharmaceutical manufacturing, quality assurance, and control. Axel Schroeder, Operations Director at Concept Heidelberg discusses

A walk through the cleanroom qualification journey

Cleanroom qualification runs from URS to DQ, to IQ, to OQ and finally PQ. Graham Findlay, Regional Director at Thomas & Adamson, part of Egis Group, explains

G-CON expands offering for ISO Class 5 cleanrooms

The US-based cleanroom construction and services specialist has announced an expansion to its supporting cleanroom services offering

Technickon expands in Ireland to grow cleanroom rectification services

The UK-based company has opened two offices in Ireland to capitalised on demand for rectification services in the region

Launches, mergers, and liquidations: A review of the cleanroom sector in 2024

A look back at the new product launches, new companies and new partnerships in the cleanroom sector in 2024

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

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

Sponsor content

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

Medicinal cannabis production with GMP-compliant cleanroom solutions

Controlled environments are supporting quality, safety and regulatory compliance in cannabis manufacturing

NewAge Inc. awarded platinum EcoVadis rating for sustainability

Fluid transfer solutions company recognised among top 1% of global performers

Uncovering blind spots in environmental monitoring

Explore how a modern microbial method can improve contamination control and data quality

Cleanrooms and clean utilities: The importance of sound design and construction

A robust contamination control strategy begins with GMP-compliant design, hygienic construction and proper maintenance

Cleanroom Solutions embracing the future to elevate their large-scale facility construction provision

The Guardtech Group’s heritage turnkey brand are utilising state-of-the-art software to take their offering to another level

AnalytiChem launches Redipor ready-to-use culture media as global brand

Redipor combines 150+ years of prepared media expertise across three certified facilities

How often should I certify my cleanroom to ISO standards?

The frequency of cleanroom certification to ISO standards depends on several factors: industry regulations, the specific ISO standard being followed, the classification of...

Get protection plus comfort with Halyard PUREZERO cleanroom gloves

High-performance nitrile gloves designed for cleanroom compliance

Tema Sinergie launches ZEROC, the new automatic integrity verification system for rapid transfer ports

Discover Tema Sinergie’s isolation technology solutions for pharma at INTERPHEX NY 2025

Featured companies

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... Lighthouse offers the most complete line of contamination monitoring solutions. The leading designer and manufacturer of specialized test equipment for HEPA filters, flat sheet media, filter cartridges and respirators..
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