(189ac) Development of a Blistering Packaging Process with Nitrogen-Modified Headspace

A nitrogen overlay during blister packaging is used to reduce oxidative degradation of a drug product packaged in cold form foil blisters. The nitrogen purges ambient air to achieve ≤ 2% oxygen in the blister headspace. An offline method to measure the oxygen content of individual blister cavities was developed to improve method robustness and minimize sample manipulation. Blister packaging process parameters that impact oxygen content were identified and operating ranges were established through engineering studies. In-line oxygen measurements were correlated to offline measurements of blister headspace oxygen content to establish in-process limits and minimize rejects.