Quality & Certifications

Certified leader in manufacturing of raw serums for the in vitro diagnostic market. Biowest USA’s quality system identifies areas critical to the achievement and maintenance of quality and sets out the necessary steps for monitoring and the effectiveness of all standards and procedures.

Using specialized equipment, detailed SOP’s and audits, Biowest USA ensures quality control at every point and stage of its serum manufacturing.

Excellence in Raw Serum Manufacturing for In Vitro Diagnostics
THAWING
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Computer-controlled thaw
FILTRATION
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ISO class 7 filtration suite
FILLING
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ISO class 5 environment
LINE TO FREEZER CART
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ISO class 7 collection room
QUALITY ASSURANCE
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ISO class 13485 registered
ISO 9001 registered
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Quality Assurance

*COA and testing needs can be customized to customer's requirements