TEST METHOD VALIDATION Randall J. Troutman CPP Senior ...

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4.3 Test Methods 11607 part 2 4.3.1 All test methods used to show compliance with this part of ISO 11607 shall be validated and documented. NOTE Annex B in ISO 11607-1 contains a list of suitable test methods. 4.3.2 The test method validation shall demonstrate the suitability of the method used. The following elements shall be included: - establishment of a rationale for the selection of the appropriate test for the packaging system; - establishment of acceptance criteria; NOTE Pass/fail is a type of criteria; - determination of test method repeatability; - determination of test method reproducibility; and - establishment of test method sensitivity for integrity tests.
11607 part 1 – Annex B • What does the list include? – Standard guides – Standard practices – Standard test methods • Including some that can not be validated • From various organizations…..
Page 1 and 2: TEST METHOD VALIDATION Randall J. T
Page 3 and 4: • Background Presentation Overvie
Page 5: 4.4 Test Methods 11607 part 1 4.4.1
Page 9 and 10: Validation 1 General Definitions c
Page 11 and 12: ASTM Guidance cont. ASTM E 2282 Sta
Page 13 and 14: Definitions precision the closeness
Page 15 and 16: ASTM E 1169 Standard Guide for Cond
Page 17 and 18: ASTM E 691 Standard Practice for Co
Page 19 and 20: Definitions test method a definitiv
Page 21 and 22: ASTM E 456 Standard Terminology Rel
Page 23 and 24: Document the Exercise • The engin
Page 25 and 26: 1. Scope 1.1 method covers the meas
Page 27 and 28: Conducting a Test Method Evaluation
Page 29 and 30: Applying the process…. • ASTM F
Page 35 and 36: Non-Standardized Test Methods • A
Page 37 and 38: Randall Troutman CPP Thank You Oliv
Page 39: Additional Research • Test Method

TEST METHOD VALIDATION Randall J. Troutman CPP Senior ...

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