BIOTECHNOLOGY
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.
Industry Sectors
Every industry includes operations that demand cleanroom or controlled
environments. That’s where FMS’ expertise delivers.
“Many industry sectors require their business partners to be certified to confirm competency. Our BS EN ISO 9001:2015 and UKAS ISO 17025 certifications signify compliance with the rigorous requirements detailed in the standard and makes FMS the obvious choice to deliver these critical services”
Products
A comprehensive range of industry leading monitoring solutions from TSI and ViGIE
Industry Sectors
Monitoring solutions and expertise for controlled environments in all industries.
Services
Extensive range of bespoke contracts and services for all ‘clean air’ environment applications.
UKAS Accreditation
Rigorous certification of FMS competency and compliance to reassure our customers.
