Articles
Pre-Sterilized, Single-Use Filling Systems For Liquid Pharmaceuticals
March 26, 2008
•Article: Pre-Sterilized, Single-Use Filling Systems For Liquid Pharmaceuticals
By Eric Isberg
Product Manager, Liquid Pharmaceuticals
Bosch Packaging Technology
The use of disposable components in product downstream processing and final fill operations is increasing as the technology for performing these steps in a single-use mode improves. As a result, there is high demand for systems that support single-use purification, formulation, and filling operations.
There are several drivers behind this trend. First is the desire to realize increased processing efficiency through the elimination of preparative steps like clean-in-place (CIP) and sterilization-in-place (SIP) for product-contact equipment and parts. For example, pre-sterilized, singleuse tubing and bags can be used to replace stainless steel piping and tanks that have to be cleaned and steamed between uses. Second is the reduction of validation efforts related to the product path, in particular the elimination of cleaning validation. Products that are hard to clean out of a system, or are highly potent or toxic, often require the use of dedicated product-contact parts. This is because existing cleaning processes are inconsistent or simply do not work in removing certain products to safe levels. Third is containment of toxic products. Disposable systems can be removed, bagged, and disposed of without breaking connections and exposing the environment to products. A fourth driver is the desire to match existing single-use upstream processes that are available for new products, particularly biopharmaceuticals and other protein-based drugs.
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