Latest in Regulatory

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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LAST CHANCE: Secure your early bird tickets for the Cleanroom Technology Conference!

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The missing link in pharmaceutical disinfectant application

Matt Cokely from Ecolab looks at the overlooked applications within disinfection validation standards that motivated the expansion of its Validex package to address wiping assessment
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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

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

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 innovators who could shape the future of your business.

Latest posts in Regulatory

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

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

Sponsor content

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

Vileda Professional to host contamination control seminar at INTERPHEX 2025

Experts to share insights on innovative solutions for pharmaceutical cleanroom challenges

Amazon Filters to showcase pharmaceutical filtration solutions at INTERPHEX 2025

UK manufacturer to highlight innovations in process filtration for global pharmaceutical applications

Microbial air monitoring webinar to explore regulatory compliance and best practices

Experts discuss solutions for cleanroom microbial air sampling and contamination control

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.

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