All Facilities, utilities and cleanrooms articles – Page 2
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NewsStudy monitors particles and falling bacteria in biosafety cabinets
The type of clothing worn in aseptic manufacturing areas may impact the number of particle and airborne bacteria detected in biosafety cabinets.
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NewsSeasonal variation of microbial contamination in pharmaceutical cleanrooms
With the outdoor environment being a primary contamination source in the pharmaceutical cleanroom, measures like good manufacturing practices (GMP) is key to reduce this risk, a paper asserts.
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ReportPharma Horizons: Environmental Monitoring
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
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NewsPreventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
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ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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ArticleCell and gene therapy: manufacturing and talent trends 2023
In this interview, Stephen Ward, Chief Manufacturing Officer and Jeanette Evans, Chief Business Officer, Cell and Gene Therapy Catapult, highlight key data from the organisation’s recent GMP Manufacturing Survey and Skills Demand reports, and present insight into the sector’s current and future landscape.
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NewsNovo Nordisk to expand French production facilities
Using an investment of more than €2.1 billion, a planned expansion at one of Novo Nordisk’s strategic production sites will include additions such as aseptic production and the extension of its Quality Control Laboratory.
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NewsStarvation stress key in Micrococcus luteus cleanroom survival
Key factors behind the lengthy survival capabilities of the bacterium Micrococcus luteus (M. luteus) within a cleanroom have been reported in Tim Sandle’s recent paper.
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NewsRevised Annex 1 now effective
The much-anticipated Annex 1 revision is finally operational; manufacturers in the EU must be compliant with the GMP guideline updates when manufacturing sterile medicinal products.
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NewsStudy identifies key contamination source during ATMP manufacture
Researchers say they are the first to demonstrate contamination of over 40 percent of lipoaspirate samples for adipose tissue-derived stem cell (ADSC)-based advanced therapy medicinal product (ATMP) manufacture.
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NewsIdentifying origin of fungi in cleanrooms
Microbiology expert Tim Sandle’s recent video examined identifying the origin of fungi in pharmaceutical cleanrooms.
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Whitepaper
Whitepaper: Designing an environmental monitoring solution for GMP
A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
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NewsIdentifying bacterial isolates to help prevent cleanroom contamination
A paper aiming to identify bacterial isolates on cleanroom operators’ garments, showed these surfaces were a major source of contamination.
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ArticleVirtual reality training in pharma: just a headset away?
Here, Virtual Reality experts UCL’s Steve Hilton and University of Kent’s Blanka Szulc reflect on key developments in the use of virtual reality in an academic setting and its outlook for the future.
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NewsPharmaceutical sterility testing market to grow from $2.07b in 2027
Research suggests that the global sterility testing market will see a nearly $200 billion increase in spending on new products in the next five years.
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