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This analysis examines the need for harmonized methods in the analysis of tattoo inks. It discusses the various players involved, such as manufacturers, importers/retailers, law enforcement, NGOs, and dermatologists, and highlights the benefits and drawbacks of harmonized methods. The article concludes that the need for harmonized methods depends on the specific question being addressed.
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Analysis of Tattoo inks:Do weneedharmonizedMethods?Christopher HohlKantonales Laboratorium Basel-StadtSwitzerland
Whyanalyze, in thefirstplace? Generateinsights out ofsamples! Twobasicquestions: -Whatis in theink? -Howmuchofitis in theink? Kantonales Labor
variousplayerseachwithspecificissues • ManufacturerIngredients:Did I getwhat I ordered? Importer/RetailerRivalproduct:Whatdidtheyuse? Inks:Did I getwhat I ordered? Are theyconformwith legal restrictions?Law enforcementweed out the rotten applesNGOAnythinghazardous on themarket? • DermatologistWhatcausedmypatients’ skinrash? servicelaboratoryMethods:Achievereliableresults at reasonablecosts- how? Kantonales Labor
WhatdoesharmonizedMethodmean? • Analytical procedure,testedbyseverallaboratoriesandapprovedasfit forpurpose. • Toputit simple:Severalcooksagree upon a recipe: «harmonized» recipe Kantonales Labor
Whyharmonizedmethods? • Method was testedandapprovedbyseverallaboratories • Resultsaretrustworthy; high levelofacceptance • Methodcanbeutilizedbyotherlaboratories in relativelyshort time • Makeseconomic sense forservicelabs! • Customergetsresults 1. generatedby a transparent procedure 2. with a minimal riskofanalyticalerrors. • He orshecanmakewell-foundeddecisionswithlesschecking backwiththe lab beforehand. Kantonales Labor
fromMethodtoHarmonizedMethod • Find lab withproven in-house methodα - Lab • Other labsfamiliarizewithmethodofα - Lab • Interlaboratorytestswithreferencesamples • Compareresults, erradicateproblems (unclearprocedure, sourcesoferror) • Repeat step 3 and 4 untilmethodisruggedandfit forpurpose • Publishfinal versionasharmonizedmethod • loooooongprocess: 3 to 10 years! • In comparison: developmentof a validated in-house method: 1 to 3 years Kantonales Labor
Analytical Chemistryistechnologydriven • rapid advancesin technologyTechnology disrupturesarecommon • (newinstrumentsandmethodsdisplacethoseofyesterday) • ruleofthumb:moreinsightsat a lowercosteverythreeyears Kantonales Labor
harmonizedmethod StartPublicationtechnologyversion 1 outdated developmentversion 1version 2in serviceupgradein service Years: 3 5 6 8 10 Start Publicationversion 1version 2version 3 …… in serviceupgrade in serviceupgradeetcin service.. In-house validatedmethod Kantonales Labor
Drawbacks • Establishing a harmonizedmethodis a cumbersomeandlongprocess. • Applyingharmonizedmethodsrequires lab touseinstrumentationandproceduresasspecified,evenwhensuperioroptionswouldbe at hand. • Upgrading a harmonizedmethodiscumbersomeaswell, asyouwouldhavetoonceagainmotivateseveralqualifiedlabsfor a secondround. • Tendency: • Cementstatus quo at theexpenseofprogress. • Precaution: • Designate harmonizedMethodsasmandatory, onlyifrequired • . Kantonales Labor
Do weneedharmonizedMethods - yesorno? • Yes andNo, itdepends on thequestiontobeanswered…! Kantonales Labor
Total number? Besuretomakethem all ofthemswimbeforeyoucount. no matter how Swimmersonly? Defineswimmingconditionsfirstand: stick tothem! Kantonales Labor
Case 1:What is the total content of a compound in the ink? striving for the true value, more than one method is suitable. HMs are nice to have but not necessary Case 2: What is the level of «free» compound in the ink? Level is procedure dependent; «free» is based on a convention striving for comparable results requires a convention method mandatory HMs are indispensable! Kantonales Labor
in practice: • Compoundsharmonizedmethod essential? • Pigments no • Aromaticaminesno • aromaticaminesreleaseyesreleasemeaningbioavailablefraction • Nickel releaseyes • Preservativesno • Chromium VI releaseyes • PAHs no • PAH releaseyes • nitrosaminesno Kantonales Labor
Whatabout an all-in-onemethod? Dreamon…. Kantonales Labor