Syringe integrity
Disposable syringes are regularly used as final containers for medicines made in aseptic services. The preparation and product approval process should incorporate a 100% check that the plunger and hub are firmly in place and no leaks are evident.
When choosing a syringe and hub combination, several factors should be considered.
Closure type
Luer-lock closures provide a more secure and integral closure than luer slip, so luer-lock syringes are generally preferred. Where luer-slip syringes are used a risk assessment should document the rationale.
Fill volume
Syringes used as storage containers should not be filled to more than 85% of nominal capacity. This minimises sideways movement of the plunger during storage and transport.
The Pharmaceutical Aseptic Service Group (PASG) website provides more information about syringe fill volumes (login required).
Protection after filling
Flexing or bending of the extended plunger after filling, for example during storage and transport, should be avoided.
Validation
The NHS Pharmaceutical QA Committee published guidance on methods for integrity testing of syringes.
For additional information about neuraxial devices, refer to the SPS article Shelf lives of aseptically prepared medicines in NRFit syringes.
Attachments
Update history
- Improved accessibility. Formatting and minor amendments pending full review.
- Published