Annex 1 BioTrak Real-Time Viable Particle Counter
What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.
The BioTrak® Real-Time Viable Particle Counter, a biofluorescent particle counter, from TSI provides real-time information on microbiological contamination in pharmaceutical life science cleanrooms. That means no more waiting four or more days to know if product is at risk, if product can be released or to hand an area back to production following cleaning.
Building on TSI's decades of experience in biological particle detection for military applications, the BioTrak Particle Counter utilizes patented laser induced fluorescence optical spectroscopy to analyze each particle, resulting in real-time viable measurements.
Contaminated products pose an obvious health risk to patients. That is why pharmaceutical/life science companies are required to manufacture in controlled environments as part of their overall contamination control program. These environments must be monitored to assure control is maintained. This makes it critical that the monitoring instruments and software implemented must be capable of generating reliable, timely results with demonstrable data integrity.
TSI offers environmental monitoring systems that integrate total particle counting, viable particle monitoring (active air sampling) as well as temperature, pressure and humidity. Everything you need to verify appropriate environmental conditions for your aseptic process.