Packaging Validation Procedure (SYS-046)

This packaging validation procedure defines the requirements for packaging validation of both sterile and non-sterile products.

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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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Packaging Validation Packaging Validation Procedure (SYS 046)
SYS-046 Packaging Validation Procedure

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.

Price: $299.00

To learn more about packaging validation and monitoring of package integrity, we recommend review of the follow blogs on our website:

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Packaging Validation 300x229 Packaging Validation Procedure (SYS 046)

To review a sample Medical Device Academy procedure click below:

managment review sample SOP Packaging Validation Procedure (SYS 046)