BSE - TSE
Customer issue
In recent years, there have been strong concerns from the public about the diseases known as Bovine Spongiform Encephalopathy
(BSE) and Transmissable Spongiform Encephalopathy (TSE), caused by using inadequately treated meat and bone meal as animal feed.
You as a manufacturer of drug products need to be reassured that the substances you buy from your suppliers are as low risk as
possible.
EMD’s solution
Regulatory Affairs is responsible for ensuring that EMD’s products comply with legal and regulatory
requirements. The risk of BSE / TSE infection can be reduced to a minimum by paying careful attention to the
substance’s origin (animal species, country), inactivating treatment (temperature, pH), and actions taken to
prevent cross-contamination.
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Pharmacopoeias recommend using materials of animal origin from low-infectivity categories: based on EMEA
/ 410 / 01 system classifying tissues by their TSE infectivity. For several years now, the complete range of
EMD’s dehydrated culture media has been manufactured from low-infectivity category peptones, enzymes, amino
acids, bile salts, sugars, amino acids, and other additives. All bovine ingredients used originate from the
BSE "low risk" countries, e.g. USA, Canada, Australia, New Zealand and South America.
An important measure has been taken to minimize the risk of exposure in laboratories: EMD’s granulated culture
media minimize the formation of dust and reduce the spread of powder, thus reducing the risk of inhalation or
lab contamination when working with potentially prion-contaminated media.
Benefits for you
EMD has taken all known measures to ensure that the products you purchase from us are manufactured from
ingredients with a low risk of BSE / TSE. When appropriate, granulated culture media are used.
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