Technical Bulletin

SAFC Biosciences’ Compliance with the

European Pharmacopoeia Monograph for
Bovine Serum (No. 2262, effective April 2006)
Gamma irradiated Fetal Bovine Serum (Catalog numbers
12007, 12107 and 12207) manufactured by SAFC Biosciences
after April 1, 2006 are fully compliant with European
Pharmacopoeia Bovine Serum Monograph 04/2006:2262.
In keeping with the Monograph, all aspects of serum
procurement, processing, testing and irradiation are submitted
to a rigorous quality assurance system. Our other bovine
serum products can be custom manufactured and tested to
comply with this monograph.
All irradiated serum catalog products receive a gamma
irradiation dose range of 25 - 35 kGy. This dose has been
validated to inactivate up to six logs of adventitious agents.
Upon request, SAFC Biosciences can easily provide a custom
irradiation limit — for example, immunological veterinary
medicinal products require serum gamma irradiated at a
minimum dose of 30 kGy. A Certificate of Irradiation in
addition to a Certificate of Analysis accompanies each lot of
irradiated serum.

SAFC Biosciences guarantees traceability of serum from the For more information about this subject or other SAFC
abattoir (or donor herd) of origin to the final container. Biosciences’ products and services, please call our
Collection, processing and sterile filtering of serum is Technical Services department or e-mail us at
performed under tightly controlled conditions and meets a technicalservices@sial.com.
minimum sterility assurance level of 10-3. Quality Control
tests including composition (electrolyte, immunoglobulin
and serum enzyme levels, etc.); identification (electrophoretic
profiling); and screening for adventitious contaminants are
performed on each batch of serum.

For nearly 20 years, SAFC Biosciences has utilized gamma

irradiation as a method of eliminating or greatly reducing
the presence of adventitious organisms in serum. SAFC
Biosciences has developed a stringent dose mapping and
cold-chain management process to assure the effectiveness
and safety of irradiated serum. The process, known as
SER-TAIN™, ensures proper handling and monitoring of sera
throughout all aspects of the inactivation process. It guarantees
that all bottles of sera receive an accurate and consistent
dose of radiation, while maintaining product performance.
The SER-TAIN™ process was fully validated in 1996 and is
registered with the Food and Drug Administration in a Drug
Master File.

United States Europe Asia Pacific

SAFC Biosciences, Inc. SAFC Biosciences Ltd. SAFC Biosciences Pty Ltd.
13804 W. 107th Street Smeaton Road, West Portway 18-20 Export Drive
Lenexa, Kansas 66215 Andover, Hampshire SP10 3LF Brooklyn, Victoria 3025
USA UNITED KINGDOM AUSTRALIA
Phone
Toll free-USA
+1 913-469-5580
1 800-255-6032
Phone
Fax
+44 (0)1264-333311
+44 (0)1264-332412
Phone
Toll free-AUS
+61 (0)3-9362-4500
1 800-200-404 www.safcbiosciences.com
Fax +1 913-469-5584 E-mail info-eu@sial.com Fax +61 (0)3-9315-1656
E-mail info-na@sial.com E-mail info-ap@sial.com
 Warranty, Limitation of Remedies
SAFC Biosciences warrants to the purchaser for a period of one year from date of delivery that this product conforms to
its specifications. Other terms and conditions of this warranty are contained in SAFC Biosciences’ written warranty, a
copy of which is available upon request. ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE IMPLIED
WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE EXCLUDED. In no case will SAFC
Biosciences be liable for any special, incidental, or consequential damages arising out of this product or the use of this
product by the customer or any third party based upon breach of warranty, breach of contract, negligence, strict tort,
or any other legal theory. SAFC Biosciences expressly disclaims any warranty against claims by any third party by way of
infringement or the like. THIS PRODUCT IS INTENDED FOR PURPOSES DESCRIBED ONLY AND IS NOT INTENDED FOR
ANY HUMAN OR THERAPEUTIC USE.
Additional Terms and Conditions are contained in the product Catalog, a copy of which is available upon request.

SER-TAIN™ is a trademark of SAFC Biosciences, Inc.

© 2006 SAFC Biosciences, Inc.

Issued April 2006 T084

0206

United States Europe Asia Pacific

SAFC Biosciences, Inc. SAFC Biosciences Ltd. SAFC Biosciences Pty Ltd.
13804 W. 107th Street Smeaton Road, West Portway 18-20 Export Drive
Lenexa, Kansas 66215 Andover, Hampshire SP10 3LF Brooklyn, Victoria 3025
USA UNITED KINGDOM AUSTRALIA

www.safcbiosciences.com Phone
Toll free-USA
Fax
+1 913-469-5580
1 800-255-6032
+1 913-469-5584
Phone
Fax
E-mail
+44 (0)1264-333311
+44 (0)1264-332412
info-eu@sial.com
Phone
Toll free-AUS
Fax
+61 (0)3-9362-4500
1 800-200-404
+61 (0)3-9315-1656
E-mail info-na@sial.com E-mail info-ap@sial.com