One of the defining characteristics of the PreVAS single-use product family is the extensive validation work that goes into each product. Validations put the “V” in PreVAS! Bosch PreVAS products are intended to be used for the final fill of mainly parenteral drug products within isolators or other clean room environments; consequently, the products have to comply with the requirements that are given for the manufacturing equipment used for sterile and aseptic processes.
There are currently no specific regulatory guidelines or requirements directly applicable to single-use components or systems. Therefore, Bosch, as manufacturer of the single-use rolling diaphragm pump (RDP) and filling needle, as well as supplier of the PreVAS RDP systems, together with MilliporeSigma as the manufacturer of PreVAS RDP assemblies, collected all relevant data on the quality of the single-use component materials and performed a detailed validation program including numerous qualification and validation tests. All the data was evaluated, assessed and has been compiled into two newly available comprehensive validation guides for the PreVAS filling needle and PreVAS RDP system user.
What can you expect in these validation guides?
The PreVAS single-use filling needle user can learn more about Bosch as a needle supplier and about the manufacture of PreVAS needles, including their materials of construction, batch release criteria and the traceability afforded to each batch. Information about our validated cleaning process, biocompatibility, extractables, particulate, endotoxin and bioburden testing standards is also included.
Within the PreVAS RDP system validation guide, users will find descriptions of the rolling diaphragm pump, information about Bosch as a system supplier and MilliporeSigma as a system manufacturer. Batch release, traceability and materials of construction are detailed, as well as the complete part matrix, from which any number of combinations can be imagined to design a PreVAS RDP system. Summaries of functional integrity, biocompatibility, extractables, physiochemical, particulate, endotoxin and bioburden testing are included. Additionally, qualification tests such as fill accuracy and stress testing are summarized. Information about sterility assurance, stability and shelf life can also be found in the validation guide. Finally, explanations behind the packaging, delivery and installation of RDP systems are also included.
The newly available validation guides for both PreVAS single-use filling needles and PreVAS RDP systems are intended to provide our users with a comprehensive source for their validation investigations. If you are interested in learning more about the PreVAS validation guides, please contact the PreVAS product manager, Laura Moody at email@example.com.