{"id":5292,"date":"2025-04-24T13:50:02","date_gmt":"2025-04-24T05:50:02","guid":{"rendered":"https:\/\/www.packqc.com\/?page_id=5292"},"modified":"2026-02-02T11:08:47","modified_gmt":"2026-02-02T03:08:47","slug":"syringe-testing","status":"publish","type":"page","link":"https:\/\/www.packqc.com\/da\/solutions\/syringe-testing\/","title":{"rendered":"Spr\u00f8jte-testl\u00f8sning"},"content":{"rendered":"
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Test af spr\u00f8jtefunktionalitet<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Inden for medicinalindustrien, medicinsk udstyr og emballage til sundhedssektoren, Test af spr\u00f8jtens funktionalitet<\/strong>\u00a0er et vigtigt skridt for at sikre produktsikkerhed, funktionalitet og overholdelse af lovgivningen. Hver komponent i en spr\u00f8jte - fra stemplet til n\u00e5len og spidsen - skal opfylde strenge kriterier for ydeevne, der er defineret i internationale standarder som ISO 11040-4, ISO 7886-1 og USP . P\u00e5 Celleinstrumenter<\/strong>Vi har specialiseret os i at levere p\u00e5lidelige og tilpassede l\u00f8sninger til test af spr\u00f8jtefunktionalitet, der hj\u00e6lper producenter og fagfolk inden for kvalitetskontrol med at validere spr\u00f8jters integritet og funktionalitet med sikkerhed.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Test af stempler<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1. Test af glidekraft<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Stempelets funktion er central for spr\u00f8jtens funktion. En af de vigtigste tests evaluerer glidekraften, som m\u00e5ler b\u00e5de den kraft, der er n\u00f8dvendig for at starte bev\u00e6gelsen (break-loose-kraft), og den kontinuerlige kraft, der er n\u00f8dvendig for at opretholde en stabil bev\u00e6gelse langs r\u00f8ret<\/i><\/u><\/b>. Hvis denne kraft er for h\u00f8j, kan spr\u00f8jten v\u00e6re sv\u00e6r at betjene, hvilket f\u00f8rer til doseringsfejl. Hvis den er for lav, kan stemplet bev\u00e6ge sig utilsigtet.<\/p>

Tor at udf\u00f8re denne test monteres spr\u00f8jten vandret, og stemplet tr\u00e6kkes med konstant hastighed ved hj\u00e6lp af et motoriseret armatur. Testsystemet registrerer kraftdata i realtid og producerer en kraftforskydningskurve, der afsl\u00f8rer variationer eller spidser, der kan indikere produktionsfejl, sm\u00f8ringsproblemer eller forkert justering af komponenter. Test af glidekraft hj\u00e6lper med at sikre j\u00e6vn levering og brugerkomfort.<\/span><\/p>

Standarder<\/strong>: ISO 11040-4 bilag E, ISO 7886-1 bilag E, ISO 8537 bilag C, ISO 11499, ISO 11608-3<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"Test\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t
MST-01 Spr\u00f8jtestempelkrafttester<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Spr\u00f8jtetestning\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Test af t\u00f8nder og flanger<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1. Modstandsdygtighed over for flangebrud<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Der p\u00e5f\u00f8res en lodret kraft p\u00e5 flangen ved hj\u00e6lp af et trykfikstur, indtil flangen kn\u00e6kker. Kraften ved brud registreres. For at sikre, at flangen kan modst\u00e5 aksial kraft uden at revne eller g\u00e5 i stykker under brug.<\/p>

Standard<\/strong>: ISO 11040-4 Bilag C1<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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2. Modstandsdygtighed over for brud p\u00e5 forenden<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Gennem proben p\u00e5f\u00f8res spr\u00f8jtespidsen kraft, indtil der opst\u00e5r deformation eller brud. Dette sikrer, at cylinderen ikke g\u00e5r i stykker under belastning - is\u00e6r vigtigt i h\u00f8jtryksapplikationer som forfyldte eller injektionssystemer.<\/p>

Standard<\/strong>: ISO 11040-4 Bilag C2<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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3. M\u00e5ling af d\u00f8dt rum<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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D\u00f8drum er den m\u00e6ngde v\u00e6ske, der er tilbage i cylinderen, n\u00e5r stemplet er trykket helt ned. Overskydende d\u00f8drum kan resultere i spildt medicin eller un\u00f8jagtig dosering. M\u00e5les ved at fylde spr\u00f8jten til et kendt volumen, trykke stemplet ned og beregne den resterende v\u00e6ske enten efter v\u00e6gt eller volumen.<\/p>

Standarder<\/strong>: ISO 7886-1 bilag C, ISO 8537 bilag E<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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4. N\u00f8jagtighed i gradueringsmarkeringen<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Det sikrer, at dosismarkeringer placeres og udskrives n\u00f8jagtigt for pr\u00e6cis volumenkontrol. Ved hj\u00e6lp af et kalibreret optisk system eller en manuel m\u00e5ler sammenlignes de trykte linjer med referencev\u00e6rdier.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tKontakt os<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Test af n\u00e5le<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1. Styrke af n\u00e5lebinding<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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N\u00e5len tr\u00e6kkes lodret af en tr\u00e6ktester, indtil den l\u00f8sner sig. Den maksimale kraft registreres. For at kontrollere, at n\u00e5len sidder godt fast p\u00e5 spr\u00f8jtens nav under brug. Den m\u00e5lte kraft skal opfylde eller overskride de gr\u00e6nsev\u00e6rdier, der er defineret i ISO-standarder, for at sikre, at n\u00e5len ikke l\u00f8sner sig under injektion.<\/p>

Standarder<\/strong>: ISO 11040-4 bilag G1, ISO 7864 bilag E, ISO 11608-2 bilag B<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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2. N\u00e5lens gennemtr\u00e6ngning\/skarphed<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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At vurdere skarpheden og den lette indtr\u00e6ngning i et standardiseret medium, der simulerer hud eller v\u00e6v. N\u00e5len drives ind i et syntetisk elastomer- eller gummisubstrat, der simulerer menneskehud. Den maksimale kraft, der kr\u00e6ves for at komme ind, afspejler n\u00e5lens skarphed. En skarpere n\u00e5l kr\u00e6ver typisk mindre kraft, hvilket reducerer smerte og v\u00e6vsskade.<\/p>

Standarder:<\/strong> ISO 11040-4 bilag F, ISO 7864 bilag D<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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3. R\u00f8rets stivhed<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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For at evaluere modstandsdygtigheden over for b\u00f8jning skal det sikres, at n\u00e5len ikke deformeres under normal h\u00e5ndtering. N\u00e5len uds\u00e6ttes for en sidev\u00e6rts kraft, og afb\u00f8jningen m\u00e5les.<\/p>

Standard<\/strong>: ISO 9626 Bilag B<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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4. Modstandsdygtighed over for slangebrud<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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For at kontrollere n\u00e5lens holdbarhed og sikre sikkerheden under brug. N\u00e5len b\u00f8jes til en bestemt vinkel og uds\u00e6ttes for gentagne belastningscyklusser for at teste dens mekaniske holdbarhed.<\/p>

Standard<\/strong>: ISO 9626 Bilag C<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tKontakt os<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Test\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"Test\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Test af spids og Luer Lock-gr\u00e6nseflade<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1. LLA-halsb\u00e5ndets udtr\u00e6kningskraft<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Spr\u00f8jtespidsen og alle p\u00e5satte Luer lock-komponenter skal sikre en l\u00e6kagefri og sikker forbindelse til andet medicinsk udstyr. En vigtig test m\u00e5ler aftr\u00e6kningskraften af kraven omkring Luer-l\u00e5sen. Hvis denne komponent l\u00f8sner sig for let, kan det resultere i l\u00e6kage eller frakobling under kritiske procedurer. Brug tr\u00e6ktesteren til at tr\u00e6kke kraven aksialt, indtil den l\u00f8sner sig.<\/p>

Standard<\/strong>: ISO 11040-4 Bilag G3<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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2. LLA-halsb\u00e5ndets momentmodstand<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Luer-kravens vridningsmodstand evalueres for at sikre, at den ikke roterer eller skrues af under typiske h\u00e5ndteringskr\u00e6fter. I denne test p\u00e5f\u00f8res en rotationsbelastning, og systemet overv\u00e5ger, om kraven modst\u00e5r vridning uden at svigte.<\/p>

Standard<\/strong>: ISO 11040-4 Bilag G4<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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3. Drejningsmoment til afmontering af stiv spids<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Den kan evaluere den kraft, der kr\u00e6ves for at skrue spidsd\u00e6kslet af, og sikre, at det er sikkert, men ikke alt for stramt. Denne test indeb\u00e6rer, at spidsd\u00e6kslet drejes af en motor eller manuelt med en momentn\u00f8gle for at simulere \u00e5bning og sikre, at det kan fjernes af medicinsk personale uden for stor anstrengelse, men stadig forbliver forseglet under forsendelse og opbevaring.<\/p>

Standard<\/strong>: ISO 11040-4 Bilag G5<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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4. Aftr\u00e6kningskraft af spidsd\u00e6ksel eller n\u00e5leskjold<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Spidsh\u00e6tten eller n\u00e5leskjoldet skal ogs\u00e5 v\u00e6re sikkert under opbevaring, men skal kunne fjernes med moderat kraft, n\u00e5r det er i brug. En aftr\u00e6kningstest udf\u00f8res ved at p\u00e5f\u00f8re aksial kraft med en kontrolleret hastighed og m\u00e5le den maksimale kraft, der kr\u00e6ves for at fjerne den. Overdreven kraft kan hindre anvendeligheden, mens utilstr\u00e6kkelig modstand kan kompromittere steriliteten.<\/p>

Standard<\/strong>: ISO 11040-4 Bilag G6<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tKontakt os<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Test af spr\u00f8jtesystemets integritet<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1. Test af luftl\u00e6kage<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Test af luftl\u00e6kage evaluerer spr\u00f8jtens evne til at holde p\u00e5 trykket uden at tillade gasudveksling. Spr\u00f8jten fyldes med luft, forsegles og overv\u00e5ges for trykfald. Ethvert trykfald indikerer tilstedev\u00e6relsen af en l\u00e6kage, som kan kompromittere doseringsn\u00f8jagtigheden eller steriliteten.<\/p>

Standarder<\/strong>: ISO 7886-1 bilag B, ISO 8537 bilag B<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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2. Test af v\u00e6skel\u00e6kage<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Spr\u00f8jten fyldes med en farvet v\u00e6ske, og der s\u00e6ttes tryk p\u00e5 indvendigt. Derefter inspiceres de udvendige overflader for tegn p\u00e5 l\u00e6kage. Dette simulerer spr\u00f8jtens evne til at holde t\u00e6t, n\u00e5r den er fyldt med medicin under stress.<\/p>

Standarder<\/strong>: ISO 7886-1 bilag D, ISO 11040-4 bilag G2, ISO 8537 bilag F<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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3. Test af beholderens lukkeintegritet (CCIT)<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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For fyldte spr\u00f8jter og systemer til levering af l\u00e6gemidler er det n\u00f8dvendigt med mere avancerede metoder som test af beholderens lukkeintegritet (CCIT) for at bekr\u00e6fte den mikrobielle barrieres effektivitet. I henhold til USP kan disse tests omfatte vakuumnedbrydning, sporingsgasdetektering og h\u00f8jsp\u00e6ndingsl\u00e6kages\u00f8gning, som hver is\u00e6r er tilpasset specifikke spr\u00f8jteformater og lovkrav.<\/p>

Standarder<\/strong>: USP , ISO 11040-4<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tKontakt os<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Tal med os<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Vi forst\u00e5r kompleksiteten i spr\u00f8jteproduktion og -testning, og vi tilbyder mere end maskiner - vi tilbyder partnerskaber inden for kvalitetssikring.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tKontakt os<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Test af spr\u00f8jtefunktionalitet Inden for medicinalindustrien, medicinsk udstyr og emballage til sundhedssektoren er test af spr\u00f8jtefunktionalitet et vigtigt skridt for at sikre produktsikkerhed, funktionalitet og overholdelse af lovgivningen. Hver komponent i en spr\u00f8jte - fra stemplet til n\u00e5len og spidsen - skal opfylde strenge pr\u00e6stationskriterier, der er defineret i internationale standarder som ISO 11040-4, ISO 7886-1 og USP . [...]<\/p>","protected":false},"author":2,"featured_media":0,"parent":5290,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-5292","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/pages\/5292","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/comments?post=5292"}],"version-history":[{"count":0,"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/pages\/5292\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/pages\/5290"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/media?parent=5292"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}