INCURE Assist™ › Migration Checklist & Qualification Toolkit

Adhesive Migration Checklist & Qualification Toolkit

Everything your team needs to run an adhesive migration through change control: the data-collection checklist, the comparison-report structure Incure uses, and a sample qualification protocol you can adapt to your quality system.

1 · Adhesive Migration Checklist

Sixteen data points define an adhesive application precisely enough to select and qualify an alternative. Collect these before any candidate discussion — they are also the fields of the assessment form, so completing this checklist once feeds the whole programme. Print this page or copy the table into your change-control record.

Checklist itemWhy it matters
1 · Current adhesive manufacturer & product numberAnchors the published-property comparison and identifies the chemistry family
2 · Substrates (both sides of the joint)Adhesion is substrate-pair specific; dissimilar pairs (e.g. PC-to-TPE) narrow the field fast
3 · Surface treatmentPlasma, corona, primer or none — changes achievable bond strength and candidate list
4 · Bond-line thickness / gapDrives viscosity selection and cure-depth requirement
5 · Dispensing methodNeedle, jet, film, screen — sets the workable viscosity window
6 · Cure equipment & wavelengthCandidate must cure on the installed source, or the migration cost grows
7 · Cure intensity & durationDefines the energy actually delivered — the real cure condition to match
8 · Required handling strength / fixture timeLine takt time depends on it
9 · Operating temperature rangeFilters candidates by service temperature rating
10 · Chemical exposureCleaners, fluids, sterilants the joint must survive
11 · Sterilisation methodEtO, gamma, autoclave — must be verified on the candidate, never assumed
12 · Regulatory requirementsISO 10993, USP Class VI, UL, RoHS/REACH — determines documentation package
13 · Annual consumptionSizes the commercial case and the right pack format
14 · Current packagingSyringe, cartridge, bottle, pail — dead volume and expiry losses live here
15 · Target savingDefines success and whether the business case justifies qualification effort
16 · Required qualification dateSets the programme schedule backwards from your deadline

Prefer a document? The Incure Application Information Form (editable PDF) is the offline equivalent of this checklist and the assessment form — complete it with your team and email it to support@incurelab.com.

2 · Adhesive Comparison Report — standard structure

Incure's standard report gives your change-control file a consistent, auditable format. It states differences plainly: a balanced comparison is more credible — to your auditors and to us — than a claim that any candidate is simply better.

Report sectionContents
1 · Published-property comparisonIncumbent's current published TDS values beside Incure's published and measured values, property by property
2 · Test methodsThe standard behind every number (e.g. lap shear, durometer, elongation), so values compare like-for-like
3 · Incure laboratory resultsMeasured results on your substrates or standard coupons, as agreed
4 · Identified differencesExplicit statement of where the candidate differs and what that means in process terms
5 · Recommended process settingsDispense parameters, cure intensity/time for your installed equipment
6 · Outstanding validation workWhat remains for your quality system to verify — never silently omitted
7 · Qualification conclusionRecommendation: proceed, proceed with conditions, or do not migrate

3 · Sample Qualification Protocol

Adapt to your quality system; delete what does not apply. Incure supplies samples, settings and certificates to support each stage.

TestPurposeTypical acceptance basis
1 · Initial bond strengthBaseline lap shear / tensile vs incumbent on production substratesMeets drawing spec; parity band vs incumbent agreed in advance
2 · Aged bond strengthAccelerated ageing (heat/humidity) to projected lifeRetention ≥ agreed % of initial
3 · Thermal cyclingJoint survives expansion mismatch across service rangeNo failure, spec strength retained
4 · Humidity ageingMoisture attack on the bond lineRetention ≥ agreed % of initial
5 · Chemical immersionCleaners, fluids, sterilants exposureRetention ≥ agreed % of initial
6 · Impact / peelToughness on flexible or dissimilar jointsMeets drawing spec
7 · Cure-depth verificationFull cure through the actual bond gap at line settingsDurometer / FTIR / section per method
8 · Fluorescence inspectionExisting inspection station detects the new adhesiveDetection at line speed
9 · Sterilisation testingBond performance after EtO / gamma / autoclave, where applicableRetention ≥ agreed % after specified cycles
10 · Production trialSupervised run on the real line: dispensing, cure, takt, first-pass yieldCapability and yield vs incumbent baseline
Use it with us or without us. This toolkit is deliberately generic — it works for evaluating any adhesive supplier, not only Incure. If you want it pre-filled for your application, request an assessment and Incure returns the comparison report started, with candidate grades and recommended settings.

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