ASTM F2096-11: TMV Bubble Test

Start here: Before you start validating test methods (TMV), please read through our written guide. Here we summarize the theory you need to know about TMV in a nutshell. The following content awaits you: 

- Basics: Test Methods 

- Basics: Test Method Validation

- Regulatory & Normative Requirements 

- How to prepare for your TMV. 

- Checklist: Compliant Test Method Validation

Watch the video to learn how to fill out the TMV protocol template correctly. Use the TMV protocol template and customize it according to your needs.

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In this video we take you through the assessment form for the standard test method for the detection of gross leaks in packaging by internal pressure (bubble test) according to ASTM F2096-11. Simon will explain how to complete the assessment form to create compliant documentation. If you have any questions about this video, please contact us at office@sifo-medical.com. office@sifo-medical.com.

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Learn how to organize your raw data (attribute data) in Excel. In this example we use 3 operators (A, B, C) who each check 15 parts and perform 2 trials, i.e. we have 90 assessments. Make sure to fill in column E correctly: This information should come from your TMV protocol. Have the operators test the parts and enter the results accordingly. In the next video, Simon shows you how to analyze this data in Minitab.

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In this video we show you how to analyze your raw data in Minitab.

You record the results of the analysis in the final document, the TMV report. Watch the video for a detailed explanation on how to correctly complete the Test Method Validation Report for the bubble test according to ASTM F2096-11.

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Use this checklist to ensure your test method validation complies with all relevant MedTech regulations and standards.

Use a decision tree to prove the intended purpose of your test method.

Use this checklist to ensure that you do not forget any important steps when validating your test methods.