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Selected Capabilities Closure Integrity (CCI) Remove All High Voltage Leak Detection (HVLD) Helium leak detection Vaccum decay leak detection Dye ingress Headspace analysis Analytical testing services (E&L, spiking & compatibility) Remove All Sub-visible particles Extrables & leachables Tungsten interactions Siliconization characterization and interactions Camera inspection systems Other tests Siliconization, testing and analysis Remove All Formulization assesment System screening System validation Early quantitative measure Primary container & device selection and evaluation Remove All Detection limit down to 5 microns or less Pre-filled syringe testing Pen injector testing Autoinjector testing On-body/wearable device testing Other testing Drug combination product design verification testing Remove All Drug product–primary container testing CCI Pre-filled syringe testing Pen injector testing Autoinjector testing Onbody/wearable device testing DV sample storage Small-scale fill/finish & assembly (NFHU) Remove All Fill/finish tooling & change parts NFHU fill/finish sample build Labelling Assembly Product complaint management and root cause investigation Remove All Sample strategy, management and decontamination Defect library creation Protocol and inspection process development Tight timeline and expedited turnaround Investigation reports Combination product incoming to lot release testing Remove All Lot release sample storage Functional testing including essential performance requirements Drug product & placebo in vials Additional Services Remove All Test method development & transfer Human factors engineering DHF consultation & support Combination product development journey consultation Add Standards to Quote 1 CCI techniques High Voltage Leak Detection (HVLD) Helium leak detection Vaccum decay leak detection Dye ingress Headspace analysis 2 Analytical testing services (E&L, spiking & compatibility) Sub-visible particles Extrables & leachables Tungsten interactions Siliconization characterization and interactions Camera inspection systems Other tests 3 Siliconization, testing and analysis Formulization assesment System screening System validation Early quantitative measure 4 Primary container & device selection and evaluation Detection limit down to 5 microns or less Pre-filled syringe testing Pen injector testing Autoinjector testing On-body/wearable device testing Other testing 5 Drug combination product design verification testing Drug product–primary container testing CCI Pre-filled syringe testing Pen injector testing Autoinjector testing Onbody/wearable device testing DV sample storage 6 Small-scale fill/finish & assembly (NFHU) Fill/finish tooling & change parts NFHU fill/finish sample build Labelling Assembly 7 Product complaint management and root cause investigation Sample strategy, management and decontamination Defect library creation Protocol and inspection process development Tight timeline and expedited turnaround Investigation reports 8 Combination product incoming to lot release testing Lot release sample storage Functional testing including essential performance requirements Drug product & placebo in vials 9 Additional Services Test method development & transfer Human factors engineering DHF consultation & support Combination product development journey consultation 10 Describe your testing needs Containers Closure Integrity (CCI)cci1+High Voltage Leak Detection (HVLD)cci2+Helium leak detectioncci3+Vaccum decay leak detectioncci4+Dye ingresscci5+Headspace analysisAnalytical testingats1+Sub-visible particlesats2+Extrables & leachablesats3+Tungsten interactionsats4+Siliconization characterization and interactionsats5+Camera inspection systemsats6+Other testsSiliconization, testing and analysissta1+Formulization assesmentsta2+System screeningsta3+System validationsta4+Early quantitative measurePrimary container & device selection and evaluationpcdse1+Detection limit down to 5 microns or lesspcdse2+Pre-filled syringe testingpcdse3+Pen injector testingpcdse4+Autoinjector testingpcdse5+On-body/wearable device testingpcdse6+Other testingDrug combination product design verificationdcpdvt1+Drug product–primary container testingdcpdvt2+CCIdcpdvt3+Pre-filled syringe testingdcpdvt4+Pen injector testingdcpdvt5+Autoinjector testingdcpdvt6+Onbody/wearable device testingdcpdvt7+DV sample storageSmall-scale fill finish & assemblyssfa1+Fill/finish tooling & change partsssfa2+NFHU fill/finish sample buildssfa3+Labellingssfa4+AssemblyProduct complaint management and root cause investigationpcmrci1+Sample strategy, management and decontaminationpcmrci2+Defect library creationpcmrci3+Protocol and inspection process developmentpcmrci4+Tight timeline and expedited turnaroundpcmrci5+Investigation reportsCombination product incoming-to-lot release testingcpilrt1+Lot release sample storagecpilrt2+Functional testing including essential performance requirementscpilrt3+Drug product & placebo in vialsAdditional servicesas1+Test method development & transferas2+Human factors engineeringas3+DHF consultation & supportas4+Combination product development journey consultationDescribe your testing needs Selected Standards ISO Remove All ISO 7864 Sterile hypodermic needles for single use ISO 7886-1 Sterile hypodermic syringes for single use, manual ISO 7886-2 Sterile hypodermic syringes for single use, with power-driven syringe pumps ISO 7886-3 Sterile hypodermic syringes for single use, Auto-disabled syringes for fixed-dose immunization ISO 7886-4 Sterile hypodermic syringes for single use, with re-use prevention feature ISO 11040-4 Prefilled syringes, glass barrels for injectables and sterilized subassembled syringes ready for filling ISO 11040-6 Prefilled syringes, plastic barrels for injectables and sterilized subassembled syringes ready for filling ISO 11040-8 Prefilled syringes, requirements and test methods for finished prefilled syringes ISO 11608-1 Needle-based injection systems for medical use, requirements and test methods, needle-based injection systems ISO 11608-2 Needle-based injection systems for medical use requirements and test methods, double-ended pen needles ISO 11608-3 Needle-based injection systems for medical use, requirements and test methods containers and integrated fluid paths ISO-11608-4 Needle-based injection systems for medical use, containing electronics ISO 11608-5 Needle-based injection systems for medical use, automated functions ISO 11608-6 Needle-based injection systems for medical use, on-body delivery systems ISO 23908 Sharps injury protection, features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use, functional requirements and testing ISO 8537 Sterile single-use syringes, with or without needle, for insulin ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications, connectors for intravascular or hypodermic applications ISO 7886-2 Sterile hypodermic syringes for single use, syringes for use with power-driven syringe pumps ASTM Remove All ASTM D4169 Performance testing of shipping containers and systems ASTM D5264 Abrasion resistance of printed materials by the Sutherland Rub Tester ASTM D903 Peel or stripping strength of adhesive bonds ASTM F2391 Measuring package and seal integrity using helium as the tracer gas ASTM F2338 Nondestructive detection of leaks in packages by vacuum decay method ASTM F1929 Detecting seal leaks in porous medical packaging by dye penetration ASTM F3039 Detecting leaks in nonporous packaging or flexible barrier materials by dye penetration ASTM F1886 Determining integrity of seals for flexible packaging by visual inspection ASTM D4332 For conditioning containers, packages, or packaging components for testing ASTM F1980 Accelerated aging of sterile barrier systems and medical devices ASTM D4728 Random vibration testing of shipping containers ASTM D5276 Drop test of loaded containers by free fall ASTM D5487 Drop of loaded containers by shock machines ASTM D6653 Drop of loaded containers by shock machines ASTM E96 Gravimetric determination of water vapor transmission rate of materials ASTM F1249 Water vapor transmission rate through plastic film and sheeting using a modulated infrared sensor ASTM F3212-16 Coring testing of huber needles ASTM F2606-08 Three-point bending of balloonexpandable vascular stents and stent systems ASTM D7386 Performance Testing of Packages for Single Parcel Delivery Systems ICH Remove All ICH Q1A Stability testing of new drug substances and drug products ICH Q2 R2 Validation of analytical procedures ICH Q3D Elemental impurities USP Remove All USP 787 Subvisible particulate matter in therapeutic protein injections USP 788 Particulate matter in injections USP 1207 Package integrity evaluation—sterile products USP 1225 Validation of Compendial Procedures USP 1663 Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems USP 233 Elemental impurities USP 671 Containers—performance testing More Remove All Ph. Eur2.09.19 Particulate contamination: sub-visible particles JP6.07 Insoluble particulate matter test for injections JIS T 3201 Glass syringes ANSI/AAMI CN27:2021 For Luer Activated Valves (LAVs) incorporated Into medical devices for intravascular applications BS EN 1707 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Lock fittings BS EN 20594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. General requirements ISTA 1-3 General simulation test for individual packaged-products shipped through a parcel delivery system Add Standards to Quote ISO ASTM ICH USP Other Filter by Type ISO ASTM ICH USP Other ISO 7864 Sterile hypodermic needles for single use ISO 7886-1 Sterile hypodermic syringes for single use, manual ISO 7886-2 Sterile hypodermic syringes for single use, with power-driven syringe pumps ISO 7886-3 Sterile hypodermic syringes for single use, Auto-disabled syringes for fixed-dose immunization ISO 7886-4 Sterile hypodermic syringes for single use, with re-use prevention feature ISO 11040-4 Prefilled syringes, glass barrels for injectables and sterilized subassembled syringes ready for filling ISO 11040-6 Prefilled syringes, plastic barrels for injectables and sterilized subassembled syringes ready for filling ISO 11040-8 Prefilled syringes, requirements and test methods for finished prefilled syringes ISO 11608-1 Needle-based injection systems for medical use, requirements and test methods, needle-based injection systems ISO 11608-2 Needle-based injection systems for medical use requirements and test methods, double-ended pen needles ISO 11608-3 Needle-based injection systems for medical use, requirements and test methods containers and integrated fluid paths ISO-11608-4 Needle-based injection systems for medical use, containing electronics ISO 11608-5 Needle-based injection systems for medical use, automated functions ISO 11608-6 Needle-based injection systems for medical use, on-body delivery systems ISO 23908 Sharps injury protection, features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use, functional requirements and testing ISO 8537 Sterile single-use syringes, with or without needle, for insulin ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications, connectors for intravascular or hypodermic applications ISO 7886-2 Sterile hypodermic syringes for single use, syringes for use with power-driven syringe pumps ASTM D4169 Performance testing of shipping containers and systems ASTM D5264 Abrasion resistance of printed materials by the Sutherland Rub Tester ASTM D903 Peel or stripping strength of adhesive bonds ASTM F2391 Measuring package and seal integrity using helium as the tracer gas ASTM F2338 Nondestructive detection of leaks in packages by vacuum decay method ASTM F1929 Detecting seal leaks in porous medical packaging by dye penetration ASTM F3039 Detecting leaks in nonporous packaging or flexible barrier materials by dye penetration ASTM F1886 Determining integrity of seals for flexible packaging by visual inspection ASTM D4332 For conditioning containers, packages, or packaging components for testing ASTM F1980 Accelerated aging of sterile barrier systems and medical devices ASTM D4728 Random vibration testing of shipping containers ASTM D5276 Drop test of loaded containers by free fall ASTM D5487 Drop of loaded containers by shock machines ASTM D6653 Drop of loaded containers by shock machines ASTM E96 Gravimetric determination of water vapor transmission rate of materials ASTM F1249 Water vapor transmission rate through plastic film and sheeting using a modulated infrared sensor ASTM F3212-16 Coring testing of huber needles ASTM F2606-08 Three-point bending of balloonexpandable vascular stents and stent systems ASTM D7386 Performance Testing of Packages for Single Parcel Delivery Systems ICH Q1A Stability testing of new drug substances and drug products ICH Q2 R2 Validation of analytical procedures ICH Q3D Elemental impurities USP 787 Subvisible particulate matter in therapeutic protein injections USP 788 Particulate matter in injections USP 1207 Package integrity evaluation—sterile products USP 1225 Validation of Compendial Procedures USP 1663 Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems USP 233 Elemental impurities USP 671 Containers—performance testing Ph. Eur2.09.19 Particulate contamination: sub-visible particles JP6.07 Insoluble particulate matter test for injections JIS T 3201 Glass syringes ANSI/AAMI CN27:2021 For Luer Activated Valves (LAVs) incorporated Into medical devices for intravascular applications BS EN 1707 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Lock fittings BS EN 20594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. General requirements ISTA 1-3 General simulation test for individual packaged-products shipped through a parcel delivery system N/A Other: ISOiso1+ISO 7864 Sterile hypodermic needles for single useiso2+ISO 7886-1 Sterile hypodermic syringes for single use, manualiso3+ISO 7886-2 Sterile hypodermic syringes for single use, with power-driven syringe pumpsiso4+ISO 7886-3 Sterile hypodermic syringes for single use, Auto-disabled syringes for fixed-dose immunizationiso5+ISO 7886-4 Sterile hypodermic syringes for single use, with re-use prevention featureiso6+ISO 11040-4 Prefilled syringes, glass barrels for injectables and sterilized subassembled syringes ready for fillingiso7+ISO 11040-6 Prefilled syringes, plastic barrels for injectables and sterilized subassembled syringes ready for fillingiso8+ISO 11040-8 Prefilled syringes, requirements and test methods for finished prefilled syringesiso9+ISO 11608-1 Needle-based injection systems for medical use, requirements and test methods, needle-based injection systemsiso10+ISO 11608-2 Needle-based injection systems for medical use requirements and test methods, double-ended pen needlesiso11+ISO 11608-3 Needle-based injection systems for medical use, requirements and test methods containers and integrated fluid pathsiso12+ISO-11608-4 Needle-based injection systems for medical use, containing electronicsiso13+ISO 11608-5 Needle-based injection systems for medical use, automated functionsiso14+ISO 11608-6 Needle-based injection systems for medical use, on-body delivery systemsiso15+ISO 23908 Sharps injury protection, features for single-use hypodermic needles, introducers for catheters and needles used for blood samplingiso16+ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use, functional requirements and testingiso17+ISO 8537 Sterile single-use syringes, with or without needle, for insuliniso18+ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications, connectors for intravascular or hypodermic applicationsiso19+ISO 7886-2 Sterile hypodermic syringes for single use, syringes for use with power-driven syringe pumpsASTMastm1+ASTM D4169 Performance testing of shipping containers and systemsastm2+ASTM D5264 Abrasion resistance of printed materials by the Sutherland Rub Testerastm3+ASTM D903 Peel or stripping strength of adhesive bondsastm4+ASTM F2391 Measuring package and seal integrity using helium as the tracer gasastm5+ASTM F2338 Nondestructive detection of leaks in packages by vacuum decay methodastm6+ASTM F1929 Detecting seal leaks in porous medical packaging by dye penetrationastm7+ASTM F3039 Detecting leaks in nonporous packaging or flexible barrier materials by dye penetrationastm8+ASTM F1886 Determining integrity of seals for flexible packaging by visual inspectionastm9+ASTM D4332 For conditioning containers, packages, or packaging components for testingastm10+ASTM F1980 Accelerated aging of sterile barrier systems and medical devicesastm11+ASTM D4728 Random vibration testing of shipping containersastm12+ASTM D5276 Drop test of loaded containers by free fallastm13+ASTM D5487 Drop of loaded containers by shock machinesastm14+ASTM D6653 Drop of loaded containers by shock machinesastm15+ASTM E96 Gravimetric determination of water vapor transmission rate of materialsastm16+ASTM F1249 Water vapor transmission rate through plastic film and sheeting using a modulated infrared sensorastm17+ASTM F3212-16 Coring testing of huber needlesastm18+ASTM F2606-08 Three-point bending of balloonexpandable vascular stents and stent systemsastm19+ASTM D7386 Performance Testing of Packages for Single Parcel Delivery SystemsICHich1+ICH Q1A Stability testing of new drug substances and drug productsich2+ICH Q2 R2 Validation of analytical proceduresich3+ICH Q3D Elemental impuritiesUSPusp1+USP 787 Subvisible particulate matter in therapeutic protein injectionsusp2+USP 788 Particulate matter in injectionsusp3+USP 1207 Package integrity evaluation—sterile productsusp4+USP 1225 Validation of Compendial Proceduresusp5+USP 1663 Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systemsusp6+USP 233 Elemental impuritiesusp7+USP 671 Containers—performance testingMOREmore1+Ph. Eur2.09.19 Particulate contamination: sub-visible particlesmore2+JP6.07 Insoluble particulate matter test for injectionsmore3+JIS T 3201 Glass syringesmore4+ANSI/AAMI CN27:2021 For Luer Activated Valves (LAVs) incorporated Into medical devices for intravascular applicationsmore5+BS EN 1707 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Lock fittingsmore6+BS EN 20594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. General requirementsmore7+ISTA 1-3 General simulation test for individual packaged-products shipped through a parcel delivery systemN/A Other: Personal Information +1 Mailing Information Selected Capabilities Closure Integrity (CCI) Remove All High Voltage Leak Detection (HVLD) Helium leak detection Vaccum decay leak detection Dye ingress Headspace analysis Analytical testing services (E&L, spiking & compatibility) Remove All Sub-visible particles Extrables & leachables Tungsten interactions Siliconization characterization and interactions Camera inspection systems Other tests Siliconization, testing and analysis Remove All Formulization assesment System screening System validation Early quantitative measure Primary container & device selection and evaluation Remove All Detection limit down to 5 microns or less Pre-filled syringe testing Pen injector testing Autoinjector testing On-body/wearable device testing Other testing Drug combination product design verification testing Remove All Drug product–primary container testing CCI Pre-filled syringe testing Pen injector testing Autoinjector testing Onbody/wearable device testing DV sample storage Small-scale fill/finish & assembly (NFHU) Remove All Fill/finish tooling & change parts NFHU fill/finish sample build Labelling Assembly Product complaint management and root cause investigation Remove All Sample strategy, management and decontamination Defect library creation Protocol and inspection process development Tight timeline and expedited turnaround Investigation reports Combination product incoming to lot release testing Remove All Lot release sample storage Functional testing including essential performance requirements Drug product & placebo in vials Additional Services Remove All Test method development & transfer Human factors engineering DHF consultation & support Combination product development journey consultation Selected Standards ISO Remove All ISO 7864 Sterile hypodermic needles for single use ISO 7886-1 Sterile hypodermic syringes for single use, manual ISO 7886-2 Sterile hypodermic syringes for single use, with power-driven syringe pumps ISO 7886-3 Sterile hypodermic syringes for single use, Auto-disabled syringes for fixed-dose immunization ISO 7886-4 Sterile hypodermic syringes for single use, with re-use prevention feature ISO 11040-4 Prefilled syringes, glass barrels for injectables and sterilized subassembled syringes ready for filling ISO 11040-6 Prefilled syringes, plastic barrels for injectables and sterilized subassembled syringes ready for filling ISO 11040-8 Prefilled syringes, requirements and test methods for finished prefilled syringes ISO 11608-1 Needle-based injection systems for medical use, requirements and test methods, needle-based injection systems ISO 11608-2 Needle-based injection systems for medical use requirements and test methods, double-ended pen needles ISO 11608-3 Needle-based injection systems for medical use, requirements and test methods containers and integrated fluid paths ISO-11608-4 Needle-based injection systems for medical use, containing electronics ISO 11608-5 Needle-based injection systems for medical use, automated functions ISO 11608-6 Needle-based injection systems for medical use, on-body delivery systems ISO 23908 Sharps injury protection, features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use, functional requirements and testing ISO 8537 Sterile single-use syringes, with or without needle, for insulin ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications, connectors for intravascular or hypodermic applications ISO 7886-2 Sterile hypodermic syringes for single use, syringes for use with power-driven syringe pumps ASTM Remove All ASTM D4169 Performance testing of shipping containers and systems ASTM D5264 Abrasion resistance of printed materials by the Sutherland Rub Tester ASTM D903 Peel or stripping strength of adhesive bonds ASTM F2391 Measuring package and seal integrity using helium as the tracer gas ASTM F2338 Nondestructive detection of leaks in packages by vacuum decay method ASTM F1929 Detecting seal leaks in porous medical packaging by dye penetration ASTM F3039 Detecting leaks in nonporous packaging or flexible barrier materials by dye penetration ASTM F1886 Determining integrity of seals for flexible packaging by visual inspection ASTM D4332 For conditioning containers, packages, or packaging components for testing ASTM F1980 Accelerated aging of sterile barrier systems and medical devices ASTM D4728 Random vibration testing of shipping containers ASTM D5276 Drop test of loaded containers by free fall ASTM D5487 Drop of loaded containers by shock machines ASTM D6653 Drop of loaded containers by shock machines ASTM E96 Gravimetric determination of water vapor transmission rate of materials ASTM F1249 Water vapor transmission rate through plastic film and sheeting using a modulated infrared sensor ASTM F3212-16 Coring testing of huber needles ASTM F2606-08 Three-point bending of balloonexpandable vascular stents and stent systems ASTM D7386 Performance Testing of Packages for Single Parcel Delivery Systems ICH Remove All ICH Q1A Stability testing of new drug substances and drug products ICH Q2 R2 Validation of analytical procedures ICH Q3D Elemental impurities USP Remove All USP 787 Subvisible particulate matter in therapeutic protein injections USP 788 Particulate matter in injections USP 1207 Package integrity evaluation—sterile products USP 1225 Validation of Compendial Procedures USP 1663 Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems USP 233 Elemental impurities USP 671 Containers—performance testing More Remove All Ph. Eur2.09.19 Particulate contamination: sub-visible particles JP6.07 Insoluble particulate matter test for injections JIS T 3201 Glass syringes ANSI/AAMI CN27:2021 For Luer Activated Valves (LAVs) incorporated Into medical devices for intravascular applications BS EN 1707 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Lock fittings BS EN 20594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. General requirements ISTA 1-3 General simulation test for individual packaged-products shipped through a parcel delivery system I reviewed my request and confirm that my personal information is correct Submit & Proceed