概述:介绍使用SPRINT II多功能测试仪进行压力衰减泄漏测试的程序。适用于空柱和预柱的泄漏测试，以及空冷冻袋和空收集管组件的泄漏测试。也可用于开发，用于调查泄漏问题，或支持鉴定设计或装配过程。包括初始仪器设置、设置测试参数、预测试检查、运行测试和仪器校准的说明。还包括特定零件类型的测试参数。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括附件/附录: 关于本文件的泄漏测试数据表:这不是一个通用模板，它是一个5页的程序，实际上是在FDA监管机构的实验室研发操作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）已被编辑，但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司实际在做什么，谁将从中受益:流程开发人员方法开发人员质量控制人员

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 ProceduresIncluded Attachments/Appendices:Leak Testing Data SheetAbout 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.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Process Development PersonnelMethod Development PersonnelQuality Control Personnel