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    What is ISO 8 cleanroom classification? Each cleanroom class is denoted by a maximum concentration of particles per cubic meter or cubic foot of air. ISO 8 is the second lowest cleanroom classification
  2. Germfree mobile cleanroom finishes pilot programme for hospital lidocaine production Modular cleanroom expert Germfree and pharma expert ODP are now working to expand a pilot programme after a successful six months of producing medications at North Mississippi...
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    Integrity testing of HEPA filters: A practical approach Filtering the air in aseptic process areas is critical to maintaining the cleanliness of the production environment. Jesus Casas provides tips to ensure HEPA filters are fit...
  4. When to Replace your HEPA Filter – According to a Cleanroom Expert One of the most crucial elements in operating clean and sterile rooms is the use of HEPA filters, which are effective in capturing particles of almost all sizes. However, over...
  5. APIs: Bioreactor hoists with a multipurpose twist Peter Devenny of PalPharma describes the solution for a biotech facility in Switzerland designed to handle filled bioreactors across GMP areas to produce ten metric tons of...

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Design & Build

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 the pharmacist begin? Words by by Patrycja Sitek
Design & Build

Cleanroom Technology Conference 2023 | Review

Angstrom Technology, Ecolab, Elis Cleanroom, AstraZeneca, Pfizer, GEA, and more! All names you could have snagged yourself a conversation with at this year’s Cleanroom Technology Conference. For two days in Birmingham representatives from all over the cleanroom sector met for an exhibition and conference that is at the pinnacle of their industry. Here is a taste of what you missed!
Design & Build

Elimination of contaminants in GMP cleanliness classes and pharmaceuticals

Special requirements are directed towards production in high ISO/GMP purity classes, where the manufacturing process takes place under sterile conditions
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Personal Protection

Clothing and hygiene of cleanroom personnel of ISO 8 and ISO 7 classes

Cleanrooms belong to an exclusive group of areas with special requirements regarding infrastructure, environmental monitoring and staff competence and hygiene. Words by Patrycja Sitek, PhD, CRK owner
Personal Protection

Disinfection and sanitisation of the clean zones: Part 1 - More means better?

Regular well planned disinfection is crucial for a quick response in the event of microbiological incidents. Here Patrycja Sitek at CRK discusses achieving the most optimum, economic result that's safe for the processes and clean zones
Cleaning

Back to basics: Control your zones

The sanitation process varies depending on the industry, but Patricia Sitek from CR Konsulting talks about common ways to categorise areas in a facility from any sector, and some golden rules to follow for them
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