Devro

3.0 DEVRO - BIOMEDICAL PRODUCTS

Devro is a contract manufacturer of collagen-based materials for use in medical, pharmaceutical and/or cosmetic applications. Devro collaborates closely with its customers, and in the strictest confidence, to develop products designed to meet the customer's stringent requirements.

Our collagen is typically sourced from Hereford cattle, with hide weights usually ranging from about 25 - 45kg - this corresponds roughly to an age range of about 2 - 4 years. All cattle are slaughtered in export-approved abattoirs and are subject to pre- and post-mortem examination by qualified veterinarians. Facilities exist, if a customer so desires, to trace each animal back to the property of origin through tail tag identification.

Devro can supply comprehensive documentation if required, including the Certificate of Registration from the source abattoir, a National Vendor Declaration, Australian Quarantine & Inspection Service export certification, and Commonwealth Government veterinary declaration covering the disease-free status of the animals. In addition, Devro provides its own Certificate of Analysis for each batch of material, and batch processing records are also made available to the customer if required.

Devro's scientists and engineers have been working with collagen for many years, and use this wealth of experience and knowledge to help tailor products that meet the customer's individual needs. From deciding on the best starting material, through the various processing steps and the characteristics of the finished product, Devro staff work with you. Packaging, too, will be treated with the same level of dedication, because we know there's no point in making a quality product, only to have it destroyed or damaged in transit. Products are generally deep frozen first, then packed into suitable containers with dry ice on the morning of dispatch.

Devro uses a freight forwarding agent in Sydney who has many years experience in dealing with our company, and understands the need to get our products to the customer in perfect condition and in the shortest possible time. However, customers sometimes prefer to arrange shipment through their own agents - Devro is happy to accommodate these arrangements too.

 

3.1 Specifications

A typical raw material specification that may apply to medical-grade bovine collagen is given below.

3.1.1 Brown hides from Hereford/Hereford-cross breeds shall be favoured. All animals will come from herds subject to Australian Government Veterinary Control & Certification.
3.1.2 Hides shall only be from animals fit for human consumption and shall be in the weight range 25 - 45kg
3.1.3 Hides shall be from an abattoir with a Meat Export Licence issued by the Australian Quarantine & Inspection Service (AQIS) for export to Europe, the US, and/or Japan. A copy of the Certificate shall be available to the customer upon request.
3.1.4 Hides shall only be taken from healthy cattle, slaughtered with the approval of an Australian Government Veterinary Officer or equivalent.
3.1.5 Hides shall preferably be from grass-fed cattle raised on farms where bred. All such cattle shall be purchased from an abattoir with a National Vendor Declaration to confirm their source, breeding and feeding history. Devro shall confirm availability of such Declaration within a batch record and shall procure a copy of such Declaration for company file for inspection as requested by the customer. 
3.1.6 Each batch of hides procured from an abattoir shall be from cattle with traceable herd identification tags meeting the requirements of the Australian Stock Diseases Act. Such tags shall be recorded in the batch record and be accompanied by government veterinary certification declaring the property of origin to be free of: Foot & Mouth Disease, Rinderpest, BSE, Anthrax, Brucellosis & Blue Tongue.
3.1.7 Copies of the Veterinary Certificates for all cattle processed shall be procured by Devro as part of the batch record, and be made available to the customer if requested.
3.1.8 AQIS Residue Tests on the slaughtered cattle shall be reviewed by Devro and confirmed as acceptable, with a copy kept in the batch record.
3.1.9 Devro shall assess any information pertaining to possible disease or contamination of cattle used in the production of biomedical collagen, and shall take all steps to try to ensure such hides are not used in the production process. However should such information, for whatever reason, only become available during or after processing, Devro shall notify the customer of all relevant details. Both parties can then determine the most appropriate course of action.

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DEVRO Pty. Limited
139 Sydney Road, Bathurst
NSW 2795, Australia
Fax: (61-2) 6330 8261, Tel: (61-2) 6330 8200
Email:
warren.lloyd@devro-casings.com