Drug Delivery Devices – ISO 11608 Test Standards
ZebraSci offers a complete portfolio of test solutions to the following ISO 11608 standards for needle-based injection systems. Our experienced team is adept at method development and validation of non-standard testing; we can help you quantifiably assess properties outside the boundaries of standard tests.
ISO 11608-1 — Part 1: Needle-based injection systems
- ISO 11608-2 — Part 2: Needles
- ISO 11608-3 — Part 3: Finished containers
Typical tests for Needle-Based Injection Systems (NIS) include:
Cap Removal Force Testing
Activation Force Testing
Dose Accuracy Testing
- Injection Time / Injection Depth
- Needle Shield/Safety Feature Forces
- Torsion Force (Multi-Dose Injections)
There’s more to drug delivery device development than ISO 11608. With a wealth of knowledge and experience in laboratory testing and regulatory guidance’s, ZebraSci partners with our clients to mitigate the risks associated with developing drug delivery device solutions for pharmaceutical, biotechnology and medical device clients.
Contact ZebraSci today to learn more about our drug delivery and combination product development solutions.