Characterization, Qualification, and Validation of a Disposable Final Filling Process for Parenteral

Many articles describe the growing need for and benefits of the replacement of traditional, reusable technologies with disposable, single-use components in the pharmaceutical and biotechnology industries (1–6). Replacing reusable materials (e.g., stainless steel) with disposable products is cost effective and increases operator and product safety (3–6).

For disposable technologies to be accepted by an industry, vendors must show that disposable systems can have equal or better performance than traditional systems. As vendors begin supplying complete sterile, disposable solutions to the pharmaceutical and biotechnology industries, suppliers will be required to have complete validation packages and an in-depth understanding of their products.

The first decision that must be made when designing and manufacturing a disposable assembly is the choice of materials to be used. The materials typically chosen are polymeric materials that must be sterilized using common sterilization methods. Typically, prepackaged, presterilized disposable assemblies are gamma irradiated at >25 kGy. Therefore, the materials of these assemblies must be nontoxic and resist changes to their physical properties after being irradiated.

Once the materials are chosen, bioburden (i.e., the level of contamination) must be minimized during the assembly process. Low levels of bioburden are required throughout the product fluid path to ensure endotoxin levels are well below accepted levels. Overall bioburden levels for inner and outer material surfaces also must be monitored carefully and maintained during the manufacture of the disposable modules to ensure the validity of the subsequent sterilization process.

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Brett M. Belongia, PhD , James A. Allay, PhD.
Pharmaceutical Technology, Mar 2, 2006.

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