Selected Capabilities
High Voltage Leak Detection (HVLD)
Helium leak detection
Vaccum decay leak detection
Dye ingress
Headspace analysis
Sub-visible particles
Extrables & leachables
Tungsten interactions
Siliconization characterization and interactions
Camera inspection systems
Other tests
Formulization assesment
System screening
System validation
Early quantitative measure
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 product–primary container testing
CCI
Pre-filled syringe testing
Pen injector testing
Autoinjector testing
Onbody/wearable device testing
DV sample storage
Fill/finish tooling & change parts
NFHU fill/finish sample build
Labelling
Assembly
Sample strategy, management and decontamination
Defect library creation
Protocol and inspection process development
Tight timeline and expedited turnaround
Investigation reports
Lot release sample storage
Functional testing including essential performance requirements
Drug product & placebo in vials
Test method development & transfer
Human factors engineering
DHF consultation & support
Combination product development journey consultation
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Selected Standards
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
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