Quality & Certifications
Specialist in manufacturing of serum for the life science industry.
Biowest USA’s quality management system defines the critical control points essential for maintaining product integrity and outlines the processes required to monitor and evaluate the effectiveness of all quality standards and procedures.
Through the use of specialized equipment, comprehensive standard operating procedures (SOPs), and regular audits, Biowest USA maintains rigorous quality control throughout every stage of serum manufacturing.
Excellence in Serum Manufacturing for Life Science Applications
THAWING
Computer-controlled thaw
FILTRATION
ISO class 7 filtration suite
FILLING
ISO class 5 environment
LINE TO FREEZER CART
ISO class 7 collection room
QUALITY ASSURANCE
ISO:13485 registered
ISO:9001 registered
Quality Assurance
- ISO 13485:2016 Certified by NQA
- ISO 9001:2015 Certified by NQA
- Traceability from raw material to finished product
- Complete traceability of all components used in manufacturing
- Full 9CFR Certificate of Analysis offered*
*COA and testing needs can be customized to customer's requirements