Studies have shown that deep cold storage temperatures can introduce risk to the container closure integrity (CCI) of vial-rubber stopper combinations traditionally used to fill sterile pharmaceutical products. The material properties of the primary packaging components at these low temperatures can sometimes result in gaps appearing at the sealing surfaces.
Studies have shown that robust and consistent vial sealing is critical for maintaining CCI at deep cold storage temperatures. A test to assess how well a vial is sealed is the measurement of the Residual Seal Force (RSF) of the compressed rubber stopper (USP<1207.3). RSF testing provides a way to quantitatively optimize and qualify the vial sealing process.
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