Standards Development

Scope

This document is applicable to aseptically processed or terminally sterilized finished prefilled syringes (intended for single use only) based on components addressed in ISO 11040-4 or ISO 11040-6, together with a front end closure and a plunger stopper (sealing the back end), for parenteral preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.

Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent-containing syringes that have been emptied for reconstitution and in which the reconstituted injectable product has been aspirated after reconstitution) are excluded from the scope of this document.

NOTE 1 This document can also be used as a guidance for other types, designs and/or sizes of finished prefilled syringes, e.g. dual chamber prefilled syringes.

NOTE 2 For finished prefilled syringes that are used in needle-based injection systems, see also references ISO 11608-1:2022[1], ISO 11608-2[2], ISO 11608-3[3], ISO 11608-4[4], ISO 11608-5[5], ISO 11608-6[6], ISO 11608-7[7]).

NOTE 3 Attention is drawn to applicable national or regional regulations and pharmacopoeias such as Ph.Eur.[1]1), USP[2]2) or JP[3]3).

NOTE 4 Finished prefilled syringes for parenteral preparations which are medical devices or which, according to the principal mode of action of the product (i.e. the means by which the product achieves its principal intended action), are borderline between medical devices and medicinal products fall within in the scope of this document, even if they are not always regulated as medicinal products.