labelqualplan

8/2/2019 LabelQualplan

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Package Label Qualification A Sample Plan

IOPP Medical Device Technical CommitteeLabeling Task Group:

Dave Olson, chair Web LabelMarilyn Heckley Smiths MedicalMark Andersen Boston ScientificGerry Gunderson Quality Tech ServicesBrent Lother Medtronic


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Considerations in designing a packagelabel testing/qualification procedure

Face stockStock finish; gloss or matteStock strength; paper or syntheticPrint surface; laser, thermal transfer, inkjet, etc.


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Considerations in designing a label testing

/ qualification procedure

Print quality and durabilityPrintability of the designComputer printer selectionAbrasion resistance; preprint and imprintChemical and solvent resistance


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/ qualification procedureAdhesive properties

Adhesive composition, e.g. hot melt, emulsionacrylic, etc.Adhesive initial tack and ultimate bondSubstrates adhered to and their shapeApplication temperature

Operating temperatureSterilization environment


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/ qualification procedure

Environmental conditionsPackage compositionShipping method and conditionsStorage conditions and length of storageChemical resistance


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A Sample Testing/Qualification Plan

Adhere samples to appropriate substrates at

an accepted sample size.Peel tests after 24-72 hours

Temperature and humidity conditioningVisual inspection and peel testsAbrasion testingSterilization and final package testsShake, rattle, and roll tests


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Common tests and standards

ASTM D3330, Peel adhesion of PS material

ASTM D5264, Sutherland abrasion and smudgeresistance testASTM F1319, Crockmeter abrasion and smudgeresistance testASTM F2252, Ink adhesion tape testASTM F 2250, Chemical exposure, inks & coatings

ASTM D4169, Distribution testing, Shake, rattle, & roll.ASTM F1980, Accelerated aging


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Some common label adhesive

conditioning cyclesLow temp cycle, 48hrs, -30F, ambient RHHumid cycle, 48hrs, 90F, 85% RHHigh temp cycle, 48 hrs, 130F, 25% RH


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Sample label stock 90 degree peel values on

Tyvek lid stock, lbs/linear inch

Label stock 20 minutes 24 hoursDevice Co A .7 .95Device Co B .74 .98

Device Co C 1.5 1.8Device Co D 1.2 fiber tear (label)Device Co E 1.2 1.6


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Summary and conclusions

There are no standardized protocols for

qualifying package labels.Design your protocol based on customerrequirements, your process, package design,and environmental conditions.Develop rationale for sample size and test

method.Develop your pass/fail protocols beforetesting begins.

labelqualplan

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