Pediatric and Geriatric Formulations: Common Challenge

Time: 11:30 am - 11:50 am

Date: 6 October 2021


Aseptic manufacturing in Grade A environments has traditionally been controlled microbiologically using interval type sampling. Rather than just sampling 1 cubic metre of air by active air sampling, new methods allow for continuous microbial monitoring throughout an entire production cycle, with minimum human intervention, both by the use of traditional TSA agar plates employed over longer periods and by real time microbial monitoring. These methods meet the current thoughts as outlined in the proposed Annex 1 revisions.


  • Shilpa Mistry Head of Pharma,UK and Ireland - Chemlink Specialities

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