Challenge

A pharmaceutical manufacturer was notified by their supplier of a formulation change in the polymer used in a container closure system (CCS) for a parenteral drug-device combination product. The change involved a reduction in antioxidant content.
Given the CCS’s role in a marketed sterile product, the sponsor faced potential regulatory concerns around changes in material stability, leachables, and biocompatibility.

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Chemva’s Solution

Chemva performed a comprehensive risk assessment focused on understanding whether the antioxidant reduction would materially impact the polymer’s performance, stability, or toxicological profile.
Our approach integrated both material testing and regulatory science to deliver a clear go/no-go decision pathway:

• Physical and Chemical Characterization:
  • Conducted Fourier-transform infrared spectroscopy (FTIR) on aged and unaged samples to detect any chemical structure differences in the polymer matrix due to antioxidant reduction.
  • Ran Differential Scanning Calorimetry (DSC) on aged and unaged polymer slabs to assess thermal stability and detect shifts.
  • Performed tensile testing under both aged and unaged conditions to evaluate mechanical integrity over time and under stress.

Based on consistent FTIR and DSC profiles, and absence of mechanical degradation, it determined that no new or elevated extractables were likely to form under normal storage or sterilization conditions. Chemva determined that additional E&L or biological testing was not warranted.

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Impact Delivered

The product remained on the market with no disruption.
Chemva’s integrated evaluation:

• Confirmed the formulation change had no meaningful impact on material safety, integrity, or performance.
• Helped the sponsor avoid unnecessary retesting, saving over 6 months in regulatory timelines and ~$150,000 in potential E&L study costs.
• Delivered a regulator-ready justification that was accepted without further inquiry.