Physical and Functional Testing of Drug Delivery Devices
Our testing provides standard and non-standard physical and functional testing (to ISO, ASTM or Pharmacopeia) on a wide range of drug delivery devices, accessories and packaging to ensure they are fit for use in our FDA registered and accredited labs in the UK, Germany, and the USA.
Our team have extensive experience supporting clients with medical device development and testing processes.
We can perform standard medical device testing and also develop and validate custom test methods to support regulatory submissions in the EU and US.
We provide support for
- Product development
- Performance to industry standards
- Performance against specific design requirements
- Production batch conformance testing and post market surveillance
- Guidance and support throughout the medical device testing process
- Building confidence in their product and its eventual use.
Our capabilities include
- Ease of use assessment
- Human factors / usability assessment
- Specific test capabilities
- Extractables and leachables
- Particulate matter analysis
- Container closure integrity
- Test method design and validation
- Verifications of product claims
- Visual inspections
- Dimensions
- Connection compatibility
See our full list of specific test capabilities.
Products include
- Metered dose inhalers (MDIs)
- Needle injection systems (NISs)
- Auto-injectors and prefilled syringes
- Terminally sterilised MDTs
- Small bore connectors
- Transfusion equipment
- Injection vials and caps
- Small bore connectors
- Contraceptive products tested to ISO 8009 and ASTM D6976-13
Specific medical devices
We also provide testing for specific devices including syringes and other drug delivery device accessories.
Physical and Functional Testing of Drug Delivery Devices
MIKE KELLY
Laboratory Manager, Physical & Functional, Medical Device Testing
United States
Contact Mike