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Novel design proposed for aseptic processing areas
The approach offers key benefits such as facilitating a reduction in the risk of microbial contamination and reduction in the required air change rate in aseptic processing.
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Aseptic Processing
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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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Improving aseptic connections throughout the manufacturing process
As companies are adapting to EU GMP guidelines for Annex 1 - Manufacture of Sterile Medicinal products, there have been numerous discussions involving the terms sterile and aseptic, as if they were synonymous. Vanessa Vasadi Figueroa, Chief Microbiologist at VVF Science® and Executive Director of Microbiology & Sterility Assurance at…
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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…
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European Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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The IMA Group at ACHEMA 2024 : All-In-One solutions for the pharmaceutical sector
At ACHEMA 2024, IMA Pharma will showcase its latest innovations, offering a range of advanced pharmaceutical product packaging and processing technology solutions.
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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.
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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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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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Embracing automation in sterile manufacturing
Krishna Venkatesh, Global Head Sterile Operations at Dr Reddy's Laboratories discusses how and why the pharma industry is embracing automation.
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Aseptic packaging market to value $35bn by 2033
Factors contributing to the growth of the aseptic packaging market include a rising demand for biologics and vaccines and greater focus on sustainability, a report states.
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Automation to guide technology shift in aseptic environments
Referencing Annex 1–2022, a paper has described how automation will be implemented in aseptic environments in view of regulatory requirements.
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Product hub: How can aseptic manufacturers prevent losses in the millions?
Highest precision with microbial air sampler MAS-100 Iso. So you can focus on the essential.
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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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Developing terminal sterilisation processes for oligonucleotide drugs
A report reviewing the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.
