We are well aware of the complexities regarding testing standards in this industry. At ZebraSci we can assist by guiding our clients’ projects through the proper protocols that we must adhere to in order to provide evidence for FDA and EU regulatory submissions.
Below is a non-exhaustive list of various standards that our team has experience with across multiple products including PFS, Pens, Autoinjectors and Wearable injector devices.
If you are interested in any of our Testing Standards, please click link below.
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ZebraSci can also help you understand the limitations of many of these testing standards and how some testing does not fall within any specific standard. Understanding these limitations may help you prevent delays in your combination product journey timeline.
If you need more information, contact us
ISO 7864 Sterile hypodermic needles for single use;iso1+ISO 7864 Sterile hypodermic needles for single use; 0
ISO 7886-1 Sterile hypodermic syringes for single use, manual;iso2+ISO 7886-1 Sterile hypodermic syringes for single use, manual; 0
ISO 7886-2 Sterile hypodermic syringes for single use, with power-driven syringe pumps;iso3+ISO 7886-2 Sterile hypodermic syringes for single use, with power-driven syringe pumps; 0
ISO 7886-3 Sterile hypodermic syringes for single use, Auto-disabled syringes for fixed-dose immunization;iso4+ISO 7886-3 Sterile hypodermic syringes for single use, Auto-disabled syringes for fixed-dose immunization; 0
ISO 7886-4 Sterile hypodermic syringes for single use, with re-use prevention feature;iso5+ISO 7886-4 Sterile hypodermic syringes for single use, with re-use prevention feature; 0
ISO 11040-4 Prefilled syringes, glass barrels for injectables and sterilized subassembled syringes ready for filling;iso6+ISO 11040-4 Prefilled syringes, glass barrels for injectables and sterilized subassembled syringes ready for filling; 0
ISO 11040-6 Prefilled syringes, plastic barrels for injectables and sterilized subassembled syringes ready for filling;iso7+ISO 11040-6 Prefilled syringes, plastic barrels for injectables and sterilized subassembled syringes ready for filling; 0
ISO 11040-8 Prefilled syringes, requirements and test methods for finished prefilled syringes;iso8+ISO 11040-8 Prefilled syringes, requirements and test methods for finished prefilled syringes; 0
ISO 11608-1 Needle-based injection systems for medical use, requirements and test methods, needle-based injection systems;iso9+ISO 11608-1 Needle-based injection systems for medical use, requirements and test methods, needle-based injection systems; 0
ISO 11608-2 Needle-based injection systems for medical use requirements and test methods, double-ended pen needles;iso10+ISO 11608-2 Needle-based injection systems for medical use requirements and test methods, double-ended pen needles; 0
ISO 11608-3 Needle-based injection systems for medical use, requirements and test methods containers and integrated fluid paths;iso11+ISO 11608-3 Needle-based injection systems for medical use, requirements and test methods containers and integrated fluid paths; 0
ISO-11608-4 Needle-based injection systems for medical use, containing electronics;iso12+ISO-11608-4 Needle-based injection systems for medical use, containing electronics; 0
ISO 11608-5 Needle-based injection systems for medical use, automated functions;iso13+ISO 11608-5 Needle-based injection systems for medical use, automated functions; 0
ISO 11608-6 Needle-based injection systems for medical use, on-body delivery systems;iso14+ISO 11608-6 Needle-based injection systems for medical use, on-body delivery systems; 0
ISO 23908 Sharps injury protection, features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling;iso15+ISO 23908 Sharps injury protection, features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling; 0
ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use, functional requirements and testing;iso16+ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use, functional requirements and testing; 0
ISO 8537 Sterile single-use syringes, with or without needle, for insulin;iso17+ISO 8537 Sterile single-use syringes, with or without needle, for insulin; 0
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications, connectors for intravascular or hypodermic applications;iso18+ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications, connectors for intravascular or hypodermic applications; 0
ISO 7886-2 Sterile hypodermic syringes for single use, syringes for use with power-driven syringe pumps;iso19+ISO 7886-2 Sterile hypodermic syringes for single use, syringes for use with power-driven syringe pumps; 0
ASTM D4169 Performance testing of shipping containers and systems;astm1+ASTM D4169 Performance testing of shipping containers and systems; 0
ASTM D5264 Abrasion resistance of printed materials by the Sutherland Rub Tester;astm2+ASTM D5264 Abrasion resistance of printed materials by the Sutherland Rub Tester; 0
ASTM D903 Peel or stripping strength of adhesive bonds;astm3+ASTM D903 Peel or stripping strength of adhesive bonds; 0
ASTM F2391 Measuring package and seal integrity using helium as the tracer gas;astm4+ASTM F2391 Measuring package and seal integrity using helium as the tracer gas; 0
ASTM F2338 Nondestructive detection of leaks in packages by vacuum decay method;astm5+ASTM F2338 Nondestructive detection of leaks in packages by vacuum decay method; 0
ASTM F1929 Detecting seal leaks in porous medical packaging by dye penetration;astm6+ASTM F1929 Detecting seal leaks in porous medical packaging by dye penetration; 0
ASTM F3039 Detecting leaks in nonporous packaging or flexible barrier materials by dye penetration;astm7+ASTM F3039 Detecting leaks in nonporous packaging or flexible barrier materials by dye penetration; 0
ASTM F1886 Determining integrity of seals for flexible packaging by visual inspection;astm8+ASTM F1886 Determining integrity of seals for flexible packaging by visual inspection; 0
ASTM D4332 For conditioning containers, packages, or packaging components for testing;astm9+ASTM D4332 For conditioning containers, packages, or packaging components for testing; 0
ASTM F1980 Accelerated aging of sterile barrier systems and medical devices;astm10+ASTM F1980 Accelerated aging of sterile barrier systems and medical devices; 0
ASTM D4728 Random vibration testing of shipping containers;astm11+ASTM D4728 Random vibration testing of shipping containers; 0
ASTM D5276 Drop test of loaded containers by free fall;astm12+ASTM D5276 Drop test of loaded containers by free fall; 0
ASTM D5487 Drop of loaded containers by shock machines;astm13+ASTM D5487 Drop of loaded containers by shock machines; 0
ASTM D6653 Drop of loaded containers by shock machines;astm14+ASTM D6653 Drop of loaded containers by shock machines; 0
ASTM E96 Gravimetric determination of water vapor transmission rate of materials;astm15+ASTM E96 Gravimetric determination of water vapor transmission rate of materials; 0
ASTM F1249 Water vapor transmission rate through plastic film and sheeting using a modulated infrared sensor;astm16+ASTM F1249 Water vapor transmission rate through plastic film and sheeting using a modulated infrared sensor; 0
ASTM F3212-16 Coring testing of huber needles;astm17+ASTM F3212-16 Coring testing of huber needles; 0
ASTM F2606-08 Three-point bending of balloonexpandable vascular stents and stent systems;astm18+ASTM F2606-08 Three-point bending of balloonexpandable vascular stents and stent systems; 0
AASTM D7386 Performance Testing of Packages for Single Parcel Delivery Systems;astm19+ASTM D7386 Performance Testing of Packages for Single Parcel Delivery Systems; 0
ICH Q1A Stability testing of new drug substances and drug products;ich1+ICH Q1A Stability testing of new drug substances and drug products; 0
ICH Q2 R2 Validation of analytical procedures;ich2+ICH Q2 R2 Validation of analytical procedures; 0
ICH Q3D Elemental impurities;ich3+ICH Q3D Elemental impurities; 0
USP 787 Subvisible particulate matter in therapeutic protein injections;usp1+USP 787 Subvisible particulate matter in therapeutic protein injections; 0
USP 788 Particulate matter in injections;usp2+USP 788 Particulate matter in injections; 0
USP 1207 Package integrity evaluation—sterile products;usp3+USP 1207 Package integrity evaluation—sterile products; 0
USP 1225 Validation of Compendial Procedures;usp4+USP 1225 Validation of Compendial Procedures; 0
USP 1663 Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems;usp5+USP 1663 Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems; 0
USP 233 Elemental impurities;usp6+USP 233 Elemental impurities; 0
USP 671 Containers—performance testing;usp7+USP 671 Containers—performance testing; 0
Ph. Eur2.09.19 Particulate contamination: sub-visible particles;more1+Ph. Eur2.09.19 Particulate contamination: sub-visible particles; 0
JP6.07 Insoluble particulate matter test for injections;more2+JP6.07 Insoluble particulate matter test for injections; 0
JIS T 3201 Glass syringes;more3+JIS T 3201 Glass syringes; 0
ANSI/AAMI CN27:2021 For Luer Activated Valves (LAVs) incorporated Into medical devices for intravascular applications;more4+ANSI/AAMI CN27:2021 For Luer Activated Valves (LAVs) incorporated Into medical devices for intravascular applications; 0
BS EN 1707 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Lock fittings;more5+BS EN 1707 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Lock fittings; 0
BS EN 20594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. General requirements;more6+BS EN 20594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. General requirements; 0
ISTA 1-3 General simulation test for individual packaged-products shipped through a parcel delivery system;more7+ISTA 1-3 General simulation test for individual packaged-products shipped through a parcel delivery system; 0