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Automating the Aseptic Process: Notes from the 2020 ISPE Aseptic Conference

A blogpost by TSI's Patrick Hutchins on the 2020 ISPE Aseptic Conference.


Patrick Hutchins, Ph.D. TSI Global Product ManagerBy Patrick Hutchins, Ph.D., Global Product Manager

From March 2-3, TSI exhibited at the 2020 ISPE Aseptic Conference in North Bethesda, Maryland. The conference was jam-packed with presentations and exhibitions. A common theme was automation of aseptic manufacturing in order to reduce human interventions.

Sample collection and other challenges

During the Robotics in Cleanrooms sessions, we heard about challenges that attendees face. An example is the manual process of microbial sample collection onto agar plates. A number of speakers mentioned TSI’s BioTrak® Real-Time Viable Particle Counter as a solution. BioTrak is a fully automated, continuous particle-monitoring instrument that eliminates the need for human interventions. Its automatic viable particle sampling also greatly simplifies data integrity concerning microbial monitoring.

Attendees concerned about data integrity

Data integrity was a recurring topic of conversation during the exhibition. An FDA inspector visited our booth, asking for more information on data integrity solutions for cleanroom particle counters. He described instances of commonly seen data integrity indiscretions. Examples included—but were not limited to—selective data deletion and shared user accounts. He was impressed to see how TSI data integrity capable particle counters made compliance foolproof for TSI users. Learn more about GMP compliance and particle counting data integrity in this blogpost by TSI’s Mike Dingle.

We’re looking forward to next year as the industry evolves even further. Learn more about the BioTrak Real-Time Viable Particle Counter and automating the aseptic process.

Publié sur mars 24 2020 15:03
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