This packaging validation procedure defines the requirements for packaging validation of both sterile and non-sterile products.
This packaging validation procedure is intended for both sterile and non-sterile product to ensure the integrity of sterile barriers and to ensure that product is not damaged during shipment. In general, the following tests need to be evaluated for packaging validation:
- Seal Validation
- Package Integrity Testing
- Seal Strength Testing
- Shelf Life Studies and Accelerated Aging (ASTM F1980)
- Transportation and Distribution Testing (ASTM D4169, ISTA1, 2, 3 series)
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SYS-046 Packaging Validation Procedure – The purpose of this procedure is to ensure packaging and shipping containers are designed and constructed in a suitable way that protects the product from contamination or damage when exposed to potential hazards during processing, storage, handling, and distribution.
To learn more about packaging validation and monitoring of package integrity, we recommend review of the following blogs on our website:
- Case Study Part 2: Packaging CAPA Preventive Action and Corrective Action
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