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HyClone Certifications of Suitability

Safe use of animal-derived starting materials in the manufacture of products for human or veterinary use depends on an evaluation of the risk of those starting materials. Many of our customers around the world have asked us to apply to the European Pharmacopoeia for a certificate of suitability for our serum-based products. This would be for compliance with their monograph on TSE safety, "Products with risk of transmitting agents of animal spongiform encephalopathies".

Certificates of suitability as currently granted are available below (Adobe Acrobat Reader required). Certificate renewal is required every 5 years. Revised and renewed certificates are added to this site.

Australia Fetal Bovine Serum

Bovine Calf Serum

Canadian Origin Fetal Bovine Serum

Central American FBS

Donor Adult Bovine Serum

Fetal Bovine Serum

Fetal Bovine Serum Alternative (FetalClone)

New Zealand Adult Bovine Serum

New Zealand Donor Bovine Calf Serum

New Zealand Newborn Bovine Serum

New Zealand Sourced Fetal Bovine Serum

For more information on the certificate of suitability please refer to http://www.pheur.org and access the
Resolutions of the Council of Europe (News/Download) for:

Resolution AP-CSP (99) 5: A new general chapter (5.2.8) on TSE
Resolution AP-CSP (99) 4: Revised procedure for Certificates of Suitability

Click Here to Request Hyclone Literature
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