The drivers for the adoption of single-use in a wide array of unit operations are numerous but there are also a few hurdles which need to be overcome to ensure a successful implementation. Among these, Leachables and Extractables concern is cited as the first factor that may restrict the use of disposables in biopharmaceutical manufacturing. Generally speaking, the questioning around the risks that the introduction of such component(s), assemblies or systems pauses is often perceived as a speed hump which can be removed by a proper risk management strategy.
Validation and Qualification needs:
"Production equipment shall not present any hazard to the products. The parts of the production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard."
European Commission, EUDRALEX Volume 4, "Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use", Chapter 3, "Premise and Equipment", 2003
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