Download Small Volume Parenterals (SVP): Regulatory, Chemistry and

Small Volume Parenterals (SVP):
Regulatory, Chemistry and Toxicology
Considerations
Agenda
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Case Study Overview
Regulatory Perspective
Chemistry Findings
Toxicological Impact
Case Study Overview
• Megavac Bio, a large US-based pharma/biotech
company.
• Vaccine, “Prevent” marketed in the US, Europe and
Asia, since 1980
• Market shift from US and Europe to Asia, where 70% of
units are sold
• Due to market shift and increasing domestic production
costs, there will be a shift in production from the US to a
contractor based in Asia.
Case Study Overview
• The drug formulation will remain the same, as well as the
production process
• Primary packaging components will be changed
• Current CCS
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3mL glass vial (13mm finish)
13mm rubber closure (blend of chlorobutyl and natural rubber)
• To change
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Container—to reduce breakage and package weight
Rubber Closure—current rubber formulation will not meet current
USP <381> Elastomeric Closures for Injections
Case Study Overview
• New CCS
• 3mL COC vial (13mm finish)
• 13mm bromobutyl rubber stopper
*Both the COC vial and rubber stopper will be made in Asia.
Case Study Overview
Supply Chain Issue
• Packaging material quality and variability
• Supplier contracts and Change Control issues
• Finished component (vial & stopper) quality and
variability including composition and dimensional
issues
Case Study Overview
Vaccine DP – CCS Compatibility Issues
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Particulates
Extractables/Leachables
Water vapor and oxygen transmission through COC vial
Migration of label adhesives/inks and other label
materials through COC vials into DP
• Migration of wooden pallet fungicide byproducts, such as
2,4,6-tribromoanisole, into COC and rubber polymers.