DOXPUB 15-0025-SOP

Summary:

Describes the procedure for pressure decay leak testing using the SPRINT II Multi-Tester. Applies to the leak testing of empty Columns and Precolumns, as well as leak testing of empty Freeze Bags and empty Collection Tube Assembly. May also be used for development use to investigate leak problems, or in support of qualifying a design or assembly process. Includes instructions for initial instrument setup, setting test parameters, pretest check, running the test, and instrument calibration. Also includes test parameters for specific part types.

Included Sections:

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

Included Attachments/Appendices:

Leak Testing Data Sheet

About This Document:

This is not a generic template, it's a 5-page procedure that was actually created and used in the Laboratory R&D 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:

• Process Development Personnel
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