Selected Capabilities

Closure Integrity (CCI)

High Voltage Leak Detection (HVLD)

Helium leak detection

Vaccum decay leak detection

Dye ingress

Headspace analysis

Analytical testing services (E&L, spiking & compatibility)

Sub-visible particles

Extrables & leachables

Tungsten interactions

Siliconization characterization and interactions

Camera inspection systems

Other tests

Siliconization, testing and analysis

Formulization assesment

System screening

System validation

Early quantitative measure

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

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

Small-scale fill/finish & assembly (NFHU)

Fill/finish tooling & change parts

NFHU fill/finish sample build

Labelling

Assembly

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

Combination product incoming to lot release testing

Lot release sample storage

Functional testing including essential performance requirements

Drug product & placebo in vials

Additional Services

Test method development & transfer

Human factors engineering

DHF consultation & support

Combination product development journey consultation

Add Standards to Quote

Selected Standards

ISO

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

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

ICH Q1A Stability testing of new drug substances and drug products

ICH Q2 R2 Validation of analytical procedures

ICH Q3D Elemental impurities

USP

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

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

Selected Capabilities

Closure Integrity (CCI)

High Voltage Leak Detection (HVLD)

Helium leak detection

Vaccum decay leak detection

Dye ingress

Headspace analysis

Analytical testing services (E&L, spiking & compatibility)

Sub-visible particles

Extrables & leachables

Tungsten interactions

Siliconization characterization and interactions

Camera inspection systems

Other tests

Siliconization, testing and analysis

Formulization assesment

System screening

System validation

Early quantitative measure

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

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

Small-scale fill/finish & assembly (NFHU)

Fill/finish tooling & change parts

NFHU fill/finish sample build

Labelling

Assembly

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

Combination product incoming to lot release testing

Lot release sample storage

Functional testing including essential performance requirements

Drug product & placebo in vials

Additional Services

Test method development & transfer

Human factors engineering

DHF consultation & support

Combination product development journey consultation

Selected Standards

ISO

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

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

ICH Q1A Stability testing of new drug substances and drug products

ICH Q2 R2 Validation of analytical procedures

ICH Q3D Elemental impurities

USP

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

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