Proposal for New Ph. Eur. Chapter on Prefillable Syringes

A new Ph. Eur. chapter 3.3.9. Prefillable plastic syringes for liquid preparations for injection is being proposed. The deadline for comments is 30 September 2026.

Prefillable plastic syringes are containers intended to be filled with a medicinal product and to remain in direct contact with that medicinal product throughout its shelf life (i.e., Prefilled Syringes, PFS). They consist of a syringe barrel with a Luer connector and tip cap or a staked non-detachable needle and needle shield, and a plunger (stopper and rod). They are sterile and suitable for aseptic filling (i.e., Ready-to-Use (RTU) container), or are terminally sterilised after filling.

Materials

The most commonly used materials for these syringes are cyclo-olefin polymers (COP, Ph. Eur. 3.1.16), cyclo-olefin copolymers (COC, Ph. Eur. 3.1.17) and polypropylene (PP, Ph. Eur. 3.1.6). The plastics and elastomer materials of which the barrel and plunger are made comply with appropriate specifications and/or with the requirements of the competent authority. If the plunger stopper, tip cap or needle shield is made of rubber, it complies with the requirements of Ph. Eur. chapter 3.2.9. (Rubber closures). If lubrication is required, silicone oil (Ph. Eur. 3.1.8) or another suitable lubricant may be applied to the internal wall of the barrel.

Tests

The proposal includes requirements (among others) for visible and sub-visible particles, bacterial endotoxins, silicone oil, transparency, and supplementary tests.

Labelling

The label states, where applicable, that the syringe has been sterilised and the method that has been used (e.g. using ethylene oxide or by irradiation). If the syringes are sterilised using ethylene oxide, they comply with the test for residual ethylene oxide using GC-MS (limit: not more than 10 ppm). 

For more information please see the draft chapter 3.3.9. Prefillable plastic syringes for liquid preparations for injection published in Pharmeuropa 38.3.