Contamination control in bioprocessing environments is essential for the safe and effective manufacture of advanced therapies. Advanced Therapy Medicinal Products (ATMP) must adhere to stringent GMP standards.
To create customised, integrated solutions and to rapidly progress cell and gene therapies, manufacturers must eliminate the risk of microbial particle contamination to enhance product quality and ensure regulatory compliance.
ATMPs and bespoke immunotherapies often have a short effective shelf life, which introduces another dimension to the environmental monitoring of the manufacturing cleanroom. Compendial particle monitoring methods can take too long to validate the cleanliness of aseptic production. The BioTrak® Real-Time Viable Particle Counter from FMS is the optimum solution. As an FDA-approved ARMM (Advanced & Rapid Microbial Method) instrument, it works as fast as you do to provide instant, real-time alerts to the presence of damaging microbial particles.