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Considerations in the Implementation of Single Use Technology – Final Fill

By simultaneously reducing the risk of contamination and providing labor, time, and materials cost savings, the use of aseptic single-use filling systems is now widespread in pharmaceutical final fill operations. By some estimates, adoption in commercial manufacturing has reached 25%, while in preclinical and clinical manufacturing it already exceeds 50%. Is your company considering switching one or more lines from CIP/SIP to single-use? The following would be important considerations to take into account to ensure smooth implementation:

  • single-use material compatibility with the drug product
  • complexity/cost of retrofitting the legacy equipment
  • development and risk management of the associated supply chain
  • handling requirements based on the installation environment (barrier system type)
  • availability of configuration options to meet final filtration requirements
  • inventory management implications
  • adequacy of the cleaning validation protocol for the single-use components

 

The PreVAS family of aseptic single-use filling systems by Bosch sets the standard in dosing system technology. PreVAS stands for “pre-Validated,” “pre-Assembled,” and “pre-Sterilized.”


Image — Installation of PreVAS Single-Use Filling System

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