Safc Biosciences - Technical Bulletin - German Safety Rating
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Technical Bulletin
German Safety Rating The German Federal Institute for Medical Supplies and Medicinal Products’ Federal Bulletin No. 40, February 26, 1994, (updated September 25, 1995), “Guidelines on Safety Measures in Connection with Medicinal Products Containing Body Materials Obtained from Cattle, Sheep, or Goats for Minimizing the Risk of Transmission of BSE and Scrapie,” outlines a specific quantitative method for evaluating the risk of transmissible Spongiform Encephalopathy (TSE) in biological products. This guideline is commonly referred to as the “German Safety Rating.” The method determines the level of risk for each of the 6 factors associated with biological products manufactured with or containing animal-derived components. The “Safety Rating” determines the negative of the log base10 risk reduction for each of the 6 risk factors. The sum of the logs of the 6 factors predicts the log reduction in risk of the product in comparison to a product that carries the highest potential risk. If the sum of the logs is 20 or higher, the product
Classification HRK MAT ABR APT ANZ APL
is considered safe. If it is less than 20 then it cannot be sold in the German market. The Safety Rating has become a useful tool in assessing the relative risk or safety of these products. The table below lists the 6 German Safety Rating risk factors and their classification acronym. Also listed in the table is the rating for SAFC Biosciences’ bovine serum sourced from both the USA and Australia. It should be noted that only 3 of the 6 factors can be applied directly to a raw material of a biological product. Also, the serum rating only applies to serum used in the manufacturing of these biological products. If other animalderived components used in the process have a lower Safety Rating, then that rating applies to the final product. For example, SAFC Biosciences’ fetal bovine serum rates 8 points for the MAT classification. However, if another component of the product has a rating of 7 points for the MAT classification then the 7 points apply toward the total safety rating.
Definition Country of Origin Starting Material Inactivation/Removal BSE Pathogens Quantities of Animal materials required to provide one Daily Dose Number of Daily Doses Route of Administration
SAFCB Bovine Serum USA 7 8 0
SAFCB Bovine Serum Australian 8 8 0
N/A
N/A
N/A N/A
N/A N/A
N/A = Not Applicable For more information about this subject or other SAFC Biosciences’ products and services, please contact our Technical Services department.
United States
Europe
Asia Pacific
SAFC Biosciences 13804 W. 107th Street Lenexa, Kansas 66215 USA Phone +1 913-469-5580 Toll free-USA 1 800-255-6032 Fax +1 913-469-5584
SAFC Biosciences Smeaton Road, West Portway Andover, Hampshire SP10 3LF UNITED KINGDOM Phone +44 (0)1264-333311 Fax +44 (0)1264-332412
SAFC Biosciences 18-20 Export Drive Brooklyn, Victoria 3025 AUSTRALIA Phone +61 (0)3-9362-4500 Toll free-AUS 1 800-200-404 Fax +61 (0)3-9315-1656
www.safcbiosciences.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.
© 2005 SAFC Biosciences Issued December 2005 XT033 0103
www.safcbiosciences.com
United States
Europe
Asia Pacific
SAFC Biosciences 13804 W. 107th Street Lenexa, Kansas 66215 USA Phone +1 913-469-5580 Toll free-USA 1 800-255-6032 Fax +1 913-469-5584
SAFC Biosciences Smeaton Road, West Portway Andover, Hampshire SP10 3LF UNITED KINGDOM Phone +44 (0)1264-333311 Fax +44 (0)1264-332412
SAFC Biosciences 18-20 Export Drive Brooklyn, Victoria 3025 AUSTRALIA Phone +61 (0)3-9362-4500 Toll free-AUS 1 800-200-404 Fax +61 (0)3-9315-1656
German Safety Rating The German Federal Institute for Medical Supplies and Medicinal Products’ Federal Bulletin No. 40, February 26, 1994, (updated September 25, 1995), “Guidelines on Safety Measures in Connection with Medicinal Products Containing Body Materials Obtained from Cattle, Sheep, or Goats for Minimizing the Risk of Transmission of BSE and Scrapie,” outlines a specific quantitative method for evaluating the risk of transmissible Spongiform Encephalopathy (TSE) in biological products. This guideline is commonly referred to as the “German Safety Rating.” The method determines the level of risk for each of the 6 factors associated with biological products manufactured with or containing animal-derived components. The “Safety Rating” determines the negative of the log base10 risk reduction for each of the 6 risk factors. The sum of the logs of the 6 factors predicts the log reduction in risk of the product in comparison to a product that carries the highest potential risk. If the sum of the logs is 20 or higher, the product
Classification HRK MAT ABR APT ANZ APL
is considered safe. If it is less than 20 then it cannot be sold in the German market. The Safety Rating has become a useful tool in assessing the relative risk or safety of these products. The table below lists the 6 German Safety Rating risk factors and their classification acronym. Also listed in the table is the rating for SAFC Biosciences’ bovine serum sourced from both the USA and Australia. It should be noted that only 3 of the 6 factors can be applied directly to a raw material of a biological product. Also, the serum rating only applies to serum used in the manufacturing of these biological products. If other animalderived components used in the process have a lower Safety Rating, then that rating applies to the final product. For example, SAFC Biosciences’ fetal bovine serum rates 8 points for the MAT classification. However, if another component of the product has a rating of 7 points for the MAT classification then the 7 points apply toward the total safety rating.
Definition Country of Origin Starting Material Inactivation/Removal BSE Pathogens Quantities of Animal materials required to provide one Daily Dose Number of Daily Doses Route of Administration
SAFCB Bovine Serum USA 7 8 0
SAFCB Bovine Serum Australian 8 8 0
N/A
N/A
N/A N/A
N/A N/A
N/A = Not Applicable For more information about this subject or other SAFC Biosciences’ products and services, please contact our Technical Services department.
United States
Europe
Asia Pacific
SAFC Biosciences 13804 W. 107th Street Lenexa, Kansas 66215 USA Phone +1 913-469-5580 Toll free-USA 1 800-255-6032 Fax +1 913-469-5584
SAFC Biosciences Smeaton Road, West Portway Andover, Hampshire SP10 3LF UNITED KINGDOM Phone +44 (0)1264-333311 Fax +44 (0)1264-332412
SAFC Biosciences 18-20 Export Drive Brooklyn, Victoria 3025 AUSTRALIA Phone +61 (0)3-9362-4500 Toll free-AUS 1 800-200-404 Fax +61 (0)3-9315-1656
www.safcbiosciences.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.
© 2005 SAFC Biosciences Issued December 2005 XT033 0103
www.safcbiosciences.com
United States
Europe
Asia Pacific
SAFC Biosciences 13804 W. 107th Street Lenexa, Kansas 66215 USA Phone +1 913-469-5580 Toll free-USA 1 800-255-6032 Fax +1 913-469-5584
SAFC Biosciences Smeaton Road, West Portway Andover, Hampshire SP10 3LF UNITED KINGDOM Phone +44 (0)1264-333311 Fax +44 (0)1264-332412
SAFC Biosciences 18-20 Export Drive Brooklyn, Victoria 3025 AUSTRALIA Phone +61 (0)3-9362-4500 Toll free-AUS 1 800-200-404 Fax +61 (0)3-9315-1656
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