List view / Grid view
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…
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…
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
At ACHEMA 2024, IMA Pharma will showcase its latest innovations, offering a range of advanced pharmaceutical product packaging and processing technology solutions.
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.
The type of clothing worn in aseptic manufacturing areas may impact the number of particle and airborne bacteria detected in biosafety cabinets.
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.
Krishna Venkatesh, Global Head Sterile Operations at Dr Reddy's Laboratories discusses how and why the pharma industry is embracing automation.
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.
Referencing Annex 1–2022, a paper has described how automation will be implemented in aseptic environments in view of regulatory requirements.
Highest precision with microbial air sampler MAS-100 Iso. So you can focus on the essential.
A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
A report reviewing the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
Researchers recommend the biological safety cabinet be used whenever possible to compound parenteral products in a clinical setting.
