Latest in Regulatory

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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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

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

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

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

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

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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.

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

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