DOXPUB 09-0050-SOP

Summary:

Describes a procedure for determining the effectiveness of the package seal strength and material integrity by slowly filling the package with air up to a predetermined steady-state pressure level safely below the burst level. Covers set-up and operation of the ARO Closed Package Test system. Applies to the thermoform tray packaging, before and after sterilization. Also applies to the film pouch packaging of tube sets after sterilization.

Included Sections:

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

Included Attachments/Appendices:

Creep Test Data Form

About This Document:

This is not a generic template, it's a 4-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.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel