TMV Guide
Your Test Method Validation Guide for Detecting Gross Leaks in Medical Device Packaging
ASTM F2096-11 Bubble Test
Training contents
3 hrs. 0 min.
TMV Guide: The Basics
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Our guide walks you through the fundamentals of Test Method Validation (TMV) in the medical device industry. It covers the key regulatory and normative requirements, outlines how to prepare effectively for a TMV, and includes a practical checklist to support compliance.
The written guide includes:
- Basics: Test Methods
- Basics: Test Method Validation (TMV)
- Regulatory and Normative Requirements
- How to prepare for your TMV
- Checklist: Compliant Test Method Validation
Downloads:
TMV_Guide_20250820.pdf
1.44 MB
PDF
30 min.
Assessment Form
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Ensure compliance with ASTM F2096-11 – documented and audit-ready. Use this Work Instruction Assessment Form to demonstrate that the bubble leak test method (ASTM F2096-11) is fully integrated into your quality management system. In the accompanying video, Simon walks you through the template step-by-step, explaining each section to help you complete it efficiently and correctly.
Downloads:
Assessment_Form_TMV_Bubble_Test_ASTM_F2096_11.docx
61.86 KB
Word
30 min.
Validation Protocol
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Ready-to-use protocol for Attribute Agreement Analysis – editable and easy to apply. Quickly adapt the included Word template to your needs and ensure regulatory compliance. In the video tutorial, Simon walks you through each section, showing exactly how to complete the protocol for MedTech validation requirements.
Downloads:
Protocol_TMV_Bubble_Test_ASTM_F2096_11_Template.docx
93.47 KB
Word
30 min.
Raw Data Analysis
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Easily organize and analyze your raw data. Use the Excel template and step-by-step video guide to structure your test data clearly and efficiently, saving time, reducing errors, and laying the groundwork for a solid TMV report.
Downloads:
TMV_RawData_attribute_3O_2T_15P_5G_10B.xlsx
10.76 KB
Excel
30 min.
Minitab Analysis
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Master your analysis in Minitab.
This video walks you through the entire data analysis process in Minitab, making it easy to interpret your results and complete your TMV with confidence.
30 min.
TMV Report
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Document your Attribute Agreement Analysis with clarity and confidence. This Test Method Validation (TMV) Report Template is designed to help you accurately document the effectiveness of pass/fail results generated by the ASTM F2096 bubble leak test for detecting gross leaks in medical packaging. The structured, audit-ready format ensures your analysis is both compliant and easy to follow. With the included step-by-step video guide, you'll learn how to complete each section, saving time and avoiding common validation pitfalls.
Downloads:
Report_TMV_Bubble_Test_ASTM_F2096_11_Template.docx
65.08 KB
Word
30 min.
Please note: This guide provides practical instructions and templates for test method validation. It does not include the full text of the ASTM standard.
Who is this guide suitable for?
This TMV Guide is ideal for MedTech professionals – including QA/RA Managers, Validation Engineers, Quality Engineers, Process Engineers, and Supplier Quality Engineers – who need to validate test methods, such as the bubble test, to ensure reliability and meet regulatory requirements and industry standards.
Special Pricing for Multiple Guides
Receive discounts when purchasing multiple guides in a single order: 20% off for 2 guides, 30% off for 3 guides, and 40% off for 4 guides.
