scope:

This part of ISO 11040 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040-4 or ISO 11040-6, together with ISO 11040-5, for parenteral injection 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 syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of this part of ISO 11040.

NOTE 1 This part of ISO 11040 can also be used as a guidance for other types, designs and/or sizes of prefilled syringes, e.g. dual chamber prefilled syringes.

NOTE 2 In case the finished prefilled syringes are used in a needle-based injection system, see also ISO 11608-3.

NOTE 3 Attention is drawn to applicable national or regional regulations such as Ph. Eur1), USP2) or JP3).

NOTE 4 Finished prefilled syringes containing so-called borderline products, e.g. hyaluronic acid, are included in the scope of this part of ISO 11040, though they are not always regulated as a pharmaceutical product.

1) See http://www.edqm.eu/.

2) See http://www.usp.org/.

3) See http://www.pmda.go.jp.