Pre-filled syringes are convenient for self administration, carers, emergency situations as well as more general use. The range of treatments to be found is large and growing. Just considering the letter ‘A’, we have: anti-thrombosis (Enoxaparin), arthritis treatment (Abatacept), and antiseptic (dental hypochlorite). Every new syringe/formulation combination requires full performance and safety validation for FDA submission and EC registration. The key parameters to analyse are: dose accuracy and availability, extractables and leachables, toxicity, ISO 11040 performance, ISO 11608 performance, stability, and maintenance of sterility. If present, anti-needle stick devices must also be shown to be effective.
MET has the leading programme for comprehensive design validation testing, including all aspects of the relevant ISO syringe standards plus usability studies and measurement of bio-availability. All work is carried out efficiently to agreed protocols, delivering your results in the shortest possible timescale.
Syringe Testing standards include:
- ISO 10993 Biological evaluation of medical devices
- ISO 11040 Pre-filled syringes
- ISO 11608 Needle-based injection systems for medical use - Requirements and test methods
- ISO 80369 Small-bore connectors for liquids and gases in healthcare applications
- ISO 11607 Packaging for terminally sterilized medical devices
- ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
- ISO 7886 Sterile hypodermic syringes for single use
- ISO 8537 Sterile single-use syringes, with or without needle, for insulin
- BS 3221 - Oral delivery syringe testing
MET has published papers on extractables and leachables testing for pre-filled syringes and PFS design validation, Click here to access our paper on design validation testing for PFSs, or contact us to request your copies.
Read more about extractables and leachables for drug delivery systems here.
Our laboratories have also developed numerous technologies for characterising PFSs, including an atmospherically controlled, non-contact dimensional measurement system for simulating air transport, and measuring air bubble expansion.