Packaging & Delivery System Integrity Tests
This section pertains to the fit of any component intended to seal or effect container closure in contact with a container. Packaging and delivery system integrity refers to the ability of a packaging and delivery system to keep the product contents in and prevent detrimental environmental contaminants from entering. All closures must ensure adequate system integrity, which is crucial for maintaining product quality. Hence, all systems within the scope of this chapter need to pass an appropriate functional suitability assessment of packaging and delivery system integrity.
Cutting-Edge Packaging and Delivery System Integrity Testing
The packaging and delivery system is considered acceptable if all test samples meet the maximum allowable leakage limit required for the product. This ensures that there is no risk to the microbiological quality of the product and that there is no significant effect on the physical and chemical properties of the product.
Assured Quality: Advanced Integrity Testing
The Package/Delivery System Integrity Tests adopt two definitions that are key concepts of USP 1207 Package Integrity Evaluation – Sterile Products:
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Maximum Allowable Leakage Limit:
The greatest leakage rate (or leak size) tolerable for a given product packaging/delivery system that poses no risk to product safety and has no impact, or inconsequential impact, on product quality. -
Inherent Integrity:
The leakage rate (or leak size) of a well-assembled packaging/delivery system with no system defect; it measures packaging/delivery system leak tightness.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
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