news
Optimal biosafety cabinet cleaning strategy proposed
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.
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Cleanrooms
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Innovating intelligent cleanroom control systems
The proposed technique outperformed traditional controllers, supporting improved air quality control in cleanrooms, according to the study.
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AI and automation to drive “substantial progress” in pharmaceutical analytical testing
Analysis cites personalised medicine, outsourcing and digitalisation as some of the key factors set to advance the pharmaceutical analytical testing market to 2032.
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Advancing environmental monitoring systems for CGT manufacturing
Gill Lewis, QP and Chief GMP Consultant, eXmoor Pharma. discusses the company's approach to environmental monitoring and the key challenges faced during integration at its Cell and Gene Therapy Centre in Bristol, a facility which received a GMP license from the MHRA in August.
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Cleanroom microbiology: single-temperature incubation for EM
Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…
whitepaper
Application note: Isokinetic microbial air sampling on MAS-100 instruments
Microbial air sampling in controlled environments should be performed isokinetically. The following text explains the isokinetic sampling process using MAS-100 instruments with a flow rate of 100 L/min and compares it with sampling at a lower flow rate of 25 L/min.
news
Microbe-carrying particle recovery efficacy with manual surface sampling
Three different contact plate methods were tested to determine a convenient manual surface sampling technique for microbial contamination recovery, the paper explained.
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Study 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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Seasonal 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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Pharma 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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Preventing 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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Year 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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Cell 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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Novo 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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Starvation 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.
