Package & Seal Integrity
Packaging and Seal Integrity Testing are vital to packaging validation of sterile medical devices as per ISO 11607. These tests verify that a sterile barrier system remained intact after Transportation Testing, Aging studies, or other trials during the validation process. The maintenance of the SBS is a critical part of any sterile medical device use and the package integrity tests can aid in the identification of defects, weaknesses or potential issues in a package which is a vital part of package validation.
Seal Strength Testing ASTM F88
Seal Strength Testing is performed to establish seal and peel strengths on packaging materials. Tests are carried out on pouches, blisters and header bags. Depending on customer requirements, Seal Strength testing can be one of the following:
- Technique A – Unsupported
- Technique B – Supported 90° (by hand)
- Technique C – Supported 180°
Burst Testing ASTM F1140
Burst Testing determines the seal strength by means of internal pressurisation. The test provides results for failure pressure and identifies the weakest points in the package and can be carried out on open or closed packages.
Dye Penetration Testing ASTM F1929 & ASTM 3039
Dye Penetration Testing examines the seal integrity between materials for imperfections such as channels in the seal or a breach of the seal. A specific dye is left in contact with the seal for a specified time and then visual inspection is performed.
Bubble Leak Testing ASTM F2096
Bubble Leak Testing verifies the integrity of the sterile barrier system. During Bubble Leak Testing, the package is internally pressurised while submerged under water and observed for a stream of bubbles that would indicate a failure area.
Visual Inspection to ASTM F1886/F1886M
Visual inspection of packaging prior or post aging/transportation testing is useful for identifying any unusual characteristics of packaging. Examples of inspection criteria include Oversealed areas, contamination in packaging, unsealed areas or additional customer acceptance criteria.
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