PAA North America
In 2005 PAA acquired the GMP production facilities of Cansera.
The facility is strategically located close to the Toronto International Airport is ideal Global Distribution of serum and media products as well as ground and air transportation throughout North America.
The 20,000 sq ft. facility is registered with FDA for production of sterile sera and media products for IVD use as well as contract production of sterile solutions. The facility is the only known North American facility that operates a completely segregated Production Suite for BSE free origin serum products. The facility and segregation is monitored by CFIA and has been subject to inspection and approval by USDA.
Licenses
- Health Canada – Health Products and Food Branch Inspecorate (HPFBI) – Medical Device Establishment License
- Device Establishment (FDA)
- EU Registration number
- USDA approved Segregated Production facility
- Certificates of Suitability for FBS, Calf Serum and Isolated Donor Bovine and Donor Calf Sera
The most important features are:
- Segregated production facilities by origin
- Dedicated GBR 1 Production Suite
- Validated true pool production of 2000 L batches
- Validated CIP and SIP Systems
- Validated Gamma Irradiation Processes