Biomanufacturing
Precision & Quality in Serum Manufacturing
Biowest USA, known as The Serum Specialist, sets the benchmark for quality and expertise in serum collection.
We understand the importance of consistency and quality. We operate our manufacturing facilities in line with ISO:9001 and ISO:13485 standards you can trust the product you receive will meet your expectations.
THAWING
- Computer controlled & monitored thawing process
- Process is trended and a trend is attached to the 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
- Every bottle weighed for accuracy of fill volume
- Caps are automatically applied and torqued to a precise specification of 28 in-lbs (inch-pounds).
FROM FILLING TO FREEZER
- ISO class 7 collection clean room
- Yearly re-certification of clean room
- Multiple labeling options depending on customers' needs
- Filtered serum is placed in a dedicated blast freezer immediately after bottle collection
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 Certificate of Analysis offered*
*COA and testing needs can be customized to customer's requirements