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Sartorius Stedim Biotech Launches Initiative to Enhance Supply Chain Security
- Membership in the RX-360 Supply Chain Consortium
- Implementation of global guidelines for the use of wooden pallets in its warehouses
- Tamper-evident packaging to be implemented for SSB's single-use products to ensure higher level of transportation security
Sartorius Stedim Biotech (SSB), a leading international pharma and biotech supplier, has substantially extended its supply chain security practices. By launching a comprehensive initiative, SSB is anticipating the emerging requirements of the biopharmaceutical industry for "end-to-end" security across the entire supply chain spectrum, as stressed by leading regulatory bodies like the FDA and related special interest groups. These groups have cited that each link in the supply chain poses a potential threat to a drug's security and that suppliers should be viewed as an extension of a biopharmaceutical manufacturer.
SSB's supply chain security initiative will cover three elements: membership in the RX-360 Consortium, implementation of global guidelines for wooden pallets and tamper-proof packaging. In order to reflect the company-wide importance of supply chain security, SSB has enrolled as a member in the RX-360 Supply Chain Consortium. The purpose of this organization is to enhance the security of the pharmaceutical supply chain by assuring the quality and authenticity of the product suppliers to the drug manufacturer. Sartorius' membership not only enhances the transparency into their quality systems for customers who are also members of RX-360, but should also reduce these customers' audit burden as well.
As a result of the concerns recently raised over the usage of wooden pallets that could potentially cause cross-contamination with chemicals due to precedent treatment, Sartorius Stedim Biotech launched a warehouse campaign as of January 2012. As part of this campaign, all SSB manufacturing sites established warehouse procedures to control wooden pallet use and storage in accordance with the specifications developed by the International Plant Protection Convention (IPPC), which are set forth in greater detail in the International Standards for Phytosanitary Measures (ISPM) 15 "Regulation of Wood Packaging Materials in International Trade."
A further important part of SSB's supply chain security initiative is the implementation of tamper-evident packaging. By using this packaging, in which a special tape indicates whether any packages have been damaged or even opened during transportation, the company has imposed even higher security standards on packaging and thus on the transportation security of its products. These concern consumables, such as presterilized single-use bags and single-use filters, which are used in biopharmaceutical manufacturing and must meet the highest quality criteria. Although SSB does not supply active ingredients or components that become part of the final drug product administered to patients, the company does supply presterilized single-use bag assemblies and filters that come in direct contact with this final product. These SSB products ensure the proper handling and sterilization of the biopharmaceutical product along the entire manufacturing process. For this reason, starting August 1, 2012, SSB will implement tamper-evident packaging for its consumable products to provide added security, as well as ensure proper transportation to their customers.
"As a supplier to the pharma industry, we aim to be ahead of the curve in proactively responding to emerging industry requirements. This is why we will be introducing a supply chain security initiative. Based on this initiative, we intend to offer the highest level of product and transportation security to ensure that our customers receive their product orders in exactly the same perfect quality and safe condition in which they leave our production facilities," commented Thomas Paust, Vice President, Supply Chain Management at Sartorius Stedim Biotech.
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