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The two-day Pharma Ed’s Aseptic Processing Summit (October 25-26, La Jolla, CA) features expert insight into the more strict aseptic processing requirements facing the pharmaceutical manufacturing industry. The summit will feature comprehensive coverage on the implementation and management of the latest knowledge in aseptic, barrier, containment, and aseptic best practice technologies.
Annex 1 currently states the recommended limit of <1 CFU/m3 for air sampling in Grade A areas. This has led many to create a requirement for new air sampling equipment of being able to detect down to 1 CFU, whether it is an active air sampler or an instrument using an alternative and rapid microbiological method (ARMM). This requirement is not complete and is insufficient to specify what is needed to be suitable for use.
In order to determine what their true requirement should be, users need to understand what a CFU is and how it is detected. This is especially important if evaluating an alternative method that detects something other than CFUs. This presentation will discuss these topics and what should be considered in a detection requirement for air sampling equipment.
Mike Dingle, TSI Field Application Specialist, provides application support for the BioTrak® Real-Time Viable Particle Counter (a biofluorescent particle counter) and other TSI products used to test and monitor controlled environments. Prior to joining TSI, Mike worked as a QC Microbiologist in the pharmaceutical and medical device industries for over 20 years where he developed and managed environmental monitoring programs for a wide variety of controlled environments.
Read Mike's recent blog >
Check out TSI solutions that meet the new Annex1 environmental monitoring requirements for continuous sampling with no interventions to assure product quality and eliminate risk >