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
Goettingen, Germany, April 27, 2012 - 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 Rx360, 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.
This press release contains statements about the future
development of the Sartorius Stedim Biotech Group. We
cannot guarantee that the content of these statements will
actually apply because these statements are based upon
assumptions and estimates that harbor certain risks and
uncertainties.