Gaining Acceptance for Real-Time Viable Particle Detection in the Pharmaceutical Manufacturing Environment

Gaining Acceptance for Real-Time Viable Particle Detection in the Pharmaceutical Manufacturing Environment

Pharmaceutical interest and excitement for fluorescence based real-time viable particle detection technology has existed for several years but acceptance and implementation has been slow.  This is primarily due to the fact that the counts generally do not match primarily due to deficiencies of the compendial method and the increased sensitivity of the fluorescence technique.  

TSI does see a path to acceptance.  There are many applications where real-time viable particle detection offers immediate benefit without the extensive validation burden presented by direct replacement of the compendial method.  Examples such as:  Release at risk scenarios where real-time measurements are used in conjunction with the compendial method.  Locating sources of contamination in real-time during root cause investigations.  HVAC air exchange optimization study times can be significantly shorted through real-time viable and total particulate detection.  These are only a few examples.  Most regulators agree that real-time viable particle detection is a tool that should be applied where applicable. 

TSI’s BioTrak; Real-Time Particle Detector includes many features well suited for these applications including ISO 21501-4 compliant total particulate counting, stand alone operation, industry leading Laser Induced Fluorescence discrimination capability and filter collection of optically analyzed particles for subsequent speciation. 

As vendors, industry, and regulators gain a better understanding of this technologies capability by applying it where it provides immediate benefit acceptance will grow.  The ultimate goal is incorporation into PAT and parametric release strategies through replacement of active air sampling and culturing.  This end goal will only be reached by applying the technology where it provides benefit today.

About TSI Incorporated
TSI Incorporated serves a global market by investigating, identifying and solving measurement problems. As an industry leader in the design and production of precision instruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, air flow, health and safety, indoor air quality, fluid dynamics and biohazard detection.