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The 2022 revision of EU GMP Annex 1 requires manufactures to ensure a high level of sterility assurance through the implementation of validated and controlled manufacturing processes prior to sterile product release. While previous versions offered a checklist of cleanroom requirements, the updated document is focused on a Quality Risk Management (QRM) and Contamination Control Strategy (CCS).
Esco Bangladesh conducts End User Training on the Esco IntelliGlove Tester (EIGT), enhancing glove integrity testing, compliance, and contamination control in pharmaceutical manufacturing.
Sterility testing is a mandatory release test for non-terminally sterilized aseptic products. Before a batch can be released to market, it must demonstrate the absence of viable microorganisms that could harm patients upon administration. A confirmed sterility failure is a serious regulatory event that may result in product recall, warning letters, or even suspension of manufacturing authorization.
Ensure compliance and consistent glove integrity testing with the Esco IntelliGlove Tester (EIGT). Wireless, portable, and ISO 14644-7 compliant, EIGT delivers traceable, repeatable results for pharmaceutical, aseptic, and biocontainment environments.
Turnkey Dismantling, Modification, and Relocation of a Multi-Glove Isolator System for a Biopharma Manufacturer
Esco Aster with the Healthcare team is making a huge comeback during this year’s International Society for Pharmaceutical Engineering (ISPE) conference in Suntec Singapore Convention & Exhibition Centre, from Aug. 18-19.
Esco Healthcare will continue to up the pace this year, so stay tuned for more technological breakthroughs and updates via our quarterly newsletter.
Esco Thailand installs one Isoclean® Healthcare Platform Isolator (HPI) for chemotherapy drug compounding at the Vibharam Hospital in Bangkok Thailand.
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