PDA’s Sterile Product Packaging- Integrity Evaluation

Sterile Product Packaging- Integrity Evaluation

Current Status and Future Direction

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This Presentation examines the evolution of sterile product package leak testing.
The key function of packaging is to protect the product from loss and contamination. Meaning: the package must not leak.
HVLD is a deterministic method of container closure integrity testing.
Deterministic vs. Probabilistic methods

Deterministic– HVLD, vacuum, tracer gas
•Leakage is based on predictable fluid flow mechanics (gas/liquids)
•Leak detection relies on P-C technologies
•NON-probabilistic
•Validatable
•Preferred if desired outcome permits
Probabilistic– Microbial ingress, tracer liquid (dye)
•Leakage is based on unpredictable, random events
•Leak detection often relies on human interpretation
•Error prone
•NOT preferred unless desired outcome demands

Click Sterile Product Packaging by PDA for the full presentation