ISO 11040-6 Revised for 2019
Published in January, ISO 11040-6:2019 Prefilled syringes -- Part 6: Plastic barrels for injectables and sterilized sub assembled syringes ready for filling, has several changes from previous versions.
There are new performance tests which must be supported by reliability and reproducibility studies to validate the tests. Acceptance criteria are given for these studies. Also, very helpfully, directions on defining sample numbers are given. Some of the new tests relate to tip and flange breakage strengths. Other strength tests associated with these products are axial and transverse breakage tests and tip and cover removal tests.
New is the requirement to define dead space/ air bubble size. MET has a unique apparatus for measuring the change in air bubble size during air transport.
Other test requirements are now described in more detail in the appendices. These include: actuation forces, endotoxin and particulate determination, evaluation of lubrication, needle penetration test, and leakage tests for closure systems (seal tests again include consideration of transport systems such as altitude testing). ISO 7864 is also invoked for measuring the needles properties.
A reduced number of dimensions are dictated in the new drawings and the connector compatibility is now referenced to ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications
All aspects of safety and performance testing for auto-injectors are effectively delivered by our dedicated teams. This is also the case for all needle based injection devices. GR&R studies are always available and many of the tests are included in our ISO 17025 accreditation.