Summary:

Describes a procedure for determing the effectiveness of thermoform tray package seal strength and material integrity by filling the package with air until is ruptures (bursts). Specifies use of ARO Close Package Test, model F100-1320-1, and ARO Automatic Control Consule, model F100-2600-1. Applies to the film pouch packaging of tube sets after sterilization. Covers pneumatic hookup, burst test setup screen, procedures for testing thermoform trays and tube set packages, and results analysis.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Burst Test Data Form

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Quality Control operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

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Who Will Benefit:

• Quality Assurance Managers
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