Biomanufacturing
Biowest USA, The Serum Specialist, provides the highest calibre of excellence and experience in the collection of serum.
We understand the importance of consistency and quality. Therefore we operate our bio-manufacturing facilities according to our ISO 9001 – registered quality management system, so that you can trust the product you receive will meet your expectations.
Precision & Quality in Serum Manufacturing
THAWING
- Computer controlled & monitored thawing process
- Process is trended and a trend is attached to batch record
FILTRATION
- ISO class 7 filtration suite
- Yearly re-certification of clean room
- All single use technology
- No cross contamination possibility between lots
- No risk of cleaning solution residue in product
FILLING
- ISO class 5 environment
- Yearly re-certification of clean room
- Custom automated fill machine contained under ISO class 5 hood
- Uo to 800 bottles X 500ml fill per hour
- Every bottle weighted for accuracy of fill volume
- Caps are automatically torqued to 28 in-lbs
FROM LINE TO FREEZER CARTS
- ISO class 7 Collection
- Yearly re-certification of clean room
- Multiple labeling options depending on customers' needs
- 4000 bottles of finished frozen serum is in a dedicated blast freezer within 8 hours
Quality Assurance
- ISO 13485 Registered
- ISO 9001 Registered
- Traceability from raw material to finished product
- Complete traceability of all components used in manufacturing
- Full 9CFR COA offered*
*COA and testing needs can be customized to customer's requirements