Servicing the Life Sciences since 1987
The Serum Specialists
Biowest USA your go to source for serum.
Providing the highest level of standards.
Providing solutions for your requirements…
Biowest USA The Serum Specialist providing the highest caliber of excellence and experience in the collection of serum. We understand the importance of consistency and quality therefore we operate our biomanufacturing facilities according to our ISO 9001 – certified quality management system so that 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 batch record
FILTRATION
- ISO class 7 filtration suite
- Yearly re-certification of clean room
- All single use technology
- No cross contaminationpossibility between lots
- No risk of cleaning solution residue in product.
FILLING
- ISO class 5 enviornment
- Yearly re-certification of clean room
- Custom automated fill machine contained under ISO class 5 hood
- Up to 800 bottles X 500ml fill per hour
- Every bottle weighed for accuracy of fill volume
- Caps are automatically torqued to 28 in-lbs.
BOTTLES 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
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QUALITY ASSURANCE
ISO 13485 Certified
ISO 9001 Certified
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 customers’ requirements
Office hours
Monday – Friday : 8:00am – 5:00pm
Address
3135 Lakewood Ranch Blvd, Suite 106
Bradenton, FL 34211.
Get in Touch!
Phone: (941) 538-6865
Email: cs@biowestusa.com
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