Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.
When it comes to meeting quality measures, manufacturers have a variety of standards from the ASTM, FDA and other organizations that they must meet.
This latest evolution of HVLD aims to achieve a high level of closed container integrity (CCI) assurance across the entire range of parenteral products.
The use of metered-dose inhalers (MDIs) for the treatment of diseases such as asthma has become popular since their introduction in the late 1950s. MDIs come in the form of nasal or oral inhalers and are much appreciated by patients who depend on them for their treatment. MDIs are designed to deliver precise/accurate and reproducible doses of the drug to the lungs or nose. This is crucial as patients rely on their inhaler to deliver the required medication at often crucial times when physical strength may be very low.
A number of industries rely on leak detection equipment and other leak testing services to ensure their products are safe and effective for consumer use: radiators, for example, are subject to a very tight leak specification to ensure that the product does not leak coolant.
The US Pharmacopoeia released a proposed revision to USP General Chapter <1207> Sterile Product Package – Integrity Evaluation for public comment, which focuses on package integrity testing. This chapter is not mandated but does reflect recommended best practices. These changes are necessary to better protect not just the product but also the patient.
Package testing and container closure integrity are cornerstones for quality. Now more than ever, innovative package designs are being used to differentiate and simplify pharmaceutical product delivery and end use. When defining package quality for your specific application there are two questions to answer.
This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka
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