Needless Injector Testing: New Design Validation Plan
Needleless injectors used for administering medicines to humans must be tested rigorously to ensure they are safe. MET has developed a needleless injector testing plan for design validation of the devices. The plan details costs and timescales for a full validation program for auto injectors.
Product specific risk analysis is required to refine the plan. The needleless injector testing is based on FDA Guidance Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with drugs and Biological Products and on ISO 21649 Needle-free injectors for medical use - Requirements and test methods.
The validation plan includes biocompatibility and packaging validation requirements, as well as injector performance tests. Assessments include: speed and depth of delivery, drug diffusion, dose accuracy and fatigue / life time testing at a variety of environmental conditions.
Our experience working with ISO 11608 has allowed us to enrich the test program, whilst streamlining the validation process. Take a look at how we carry out laboratory testing of injection systems. Our chemical analysis services can also be used to demonstrate drug compatibility for injectors and cartridges.
Some drug interaction tests are detailed in the USP. Other chemical tests cover: extractables, leachables and drug adsorption, along with container closure tests.
Contact MET to discuss a needleless injector testing programme and design validation.