TMV Guide
Your Guide to Validating Seal Integrity for Sterile Medical Devices
ASTM F1929-23 Dye Penetration Test
Training contents
3 hrs. 0 min.
TMV Guide: The Basics
Buy this item to view the content
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
Buy this item to view the content
Use the Assessment Form Template to document how the ASTM F1929-23 dye penetration test method is implemented within your quality management system. The package includes a ready-to-use template and a detailed video walkthrough, where Simon guides you through each section step-by-step.
Downloads:
Assessment_Form_TMV_Dye_Penetration_ASTM_F1929_23.docx
61.5 KB
Word
30 min.
Validation Protocol
Buy this item to view the content
Validate your pass/fail results with confidence. This protocol helps you assess how reliably your dye penetration test (ASTM F1929) detects seal leaks in porous medical packaging. You'll get a ready-to-use protocol template plus a video walkthrough that shows you exactly how to apply it, saving time and ensuring reliable results.
Downloads:
Protocol_TMV_Dye_Penetration_ASTM_F1929_23_Template.docx
89.9 KB
Word
30 min.
Raw Data Analysis
Buy this item to view the content
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
Buy this item to view the content
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
Buy this item to view the content
This Test Method Validation (TMV) Report Template helps you summarize and justify the effectiveness of your pass/fail results for detecting seal leaks in porous medical packaging using dye penetration (ASTM F1929-23). Using the template and the included video instructions, you'll complete your report faster and ensure it aligns with regulatory expectations.
Downloads:
Report_TMV_Dye_Penetration_ASTM_F1929_23_Template.docx
65.28 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 dye penetration 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.
