Regulatory

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Cleanroom Technology Conference Singapore: Early bird ticket offer ending

The early bird offer for the Cleanroom Technology Conference Singapore will end in October. Be sure to book your ticket now to secure the discounte...

USP-NF gives notices of chapter <86> on bacterial endotoxins test using recombinant reagents

USP has recognised the need for a standard with information on the use of additional reagents for bacterial endotoxin testing as many groups and co...

Farmabios builds modular facility for large-scale HPAPI and steroid production

Axplora company Farabios has announced the cGMP approval from the national public body regulating medicines for human use in Italy (AIFA) for its 2...

Annex 1: How to use CAPA in your facility?

What is Corrective Action and Preventive Action (CAPA), what are the new Annex 1’s requirements in this area, and what an organisation should be co...

ILC Dover and Flexan attain ISO certification for cleanroom in Mexico

The two companies have announced the receipt of an ISO 13485:2016 certification for their 15,000 sqft Class 7 cleanroom facility located in Juarez,...

Scientific Safety Alliance acquires Gerbig Cleanrooms’ certification division

Scientific Safety Alliance has announced the acquisition of Gerbig Cleanrooms' certification division, creating a large independent certification p...

Design and construction of a sterile drug laboratories - where does the pharmacist's role begin?

With the publication of the new Pharmacopoeia XI guidelines, hospital pharmacy sterile drug preparation labs are wondering where does the role of t...

Use of new ISO 14644-17 cleanroom standard in contamination control

In 2021 the ISO 14644 cleanroom standard part 17 on the control of macroparticles with the title “Particle deposition rate applications” was publis...

Baxter Healthcare engages Technickon to remedy cleanroom facility issues

Baxter (UK) has engaged with cleanroom specialist engineering firm Technickon to provide high-level specialist cleanroom consultancy and maintenanc...

Medical Technology Associates acquires Air Filtration Management

The controlled environment testing and certification expert has acquired AFM to further expand its northeastern US presence

Aseptic filling PUPSIT: What is it? Should I? Must I? How do I? Where do I?

There are several predictable debates and considerations that all aseptic filling operations face whether they be a newly defined project, or par...

What’s wrong with Annex 1

Alexander Fedotov, Director of Clean Technologies (formerly Invar-Project), talks about some of the changes to the new Annex 1 and his reasonings o...

AUSTAR Group and ValGenesis partner on pharmaceutical risk management solution

China-based AUSTAR has worked with a validation platform to help two large drug manufacturers in China

DACH cleanroom market report | Unanswered questions

There has been plenty going on in the cleanroom DACH market, plenty of notable projects cropping up all over the place, but there are some answered...