Latest in Regulatory

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

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CALL FOR 2025 SPEAKERS: Share your voice at the Cleanroom Technology Conference

Are you an expert in cleanroom technology or contamination control? We are seeking dynamic speakers to share their insights on the latest developments and innovations in the...
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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

Latest posts in Regulatory

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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A guide to risk assessments for cleanroom containment

Risk assessment is a crucial component of any manufacturing process. Gabriela Mikhaiel from Dec Group discusses the key ways it ensures the well-being of workers and the quality of products

Cleanrooms: Navigating regulators for environmental monitoring

The team at Lighthouse Worldwide Solutions discusses the fundamental definitions of key guidelines and regulations for Environmental Monitoring Systems (EMS) and the importance of choosing the right vendor

Impact of the new Annex 1 on sterile filling in pharma

EU GMP Annex 1 is a whole new era for the sterile filling industry. From barrier technology to “first air”, pharmaceutical manufacturers have a lot to decide. Johannes Rauschnabel from Syntegon discusses how equipment suppliers can help with implementation

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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

How quickly an Airkey FastIns modular cleanroom is assembled

Discover how a 200 m² cleanroom was built in just 7 days by 5 workers

Shared Laboratory: New Trending for Cleanrooms and Labs

Airkey completes vivarium cleanroom for cost-efficient animal research in the USA

Airkey customises USP 797&800 compliant Fast-Installation Modular Cleanroom

The China-based company Airkey builds modular cleanroom in compliance with USP 797 & 800 for a Panama pharmaceutical client

EV battery manufacturing: a journey of precision and particle contamination control

The rapid rise of electric vehicles (EVs) has brought about a surge in demand for high-quality lithium-ion batteries

Gas sampling in biopharma cleanrooms: ensuring contamination control

In the high-stakes realm of Pharmaceutical manufacturing, precision and adherence to stringent cleanliness standards are non-negotiable. Compressed gases are a staple in...

Understanding airborne particle counters in pharmaceutical facilities

Airborne particle counters play a crucial role in ensuring the environmental integrity of pharmaceutical, bio-pharmaceutical, and radiopharmaceutical facilities worldwide

Elevating EV battery manufacturing: Tackling particle contamination with ApexRBp

With the introduction of ApexRBp, manufacturers have an opportunity to be at the forefront of innovation in cleanroom technology

The importance of liquid particle counters for pharmaceutical water quality

Water quality plays a critical role in the pharmaceutical industry, where stringent requirements must be met to ensure the safety and efficacy of pharmaceutical products

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