BS ISO 11040-8:2016

This part of ISO11040 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO11040-4 or ISO11040-6, together with ISO11040-5, 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 ISO11040.

NOTE1 This part of ISO11040 can also be used as a guidance for other types, designs and/or sizes of prefilled syringes, e.g. dual chamber prefilled syringes.

NOTE2 In case the finished prefilled syringes are used in a needle-based injection system, see also ISO11608-3.

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 ISO11040, though they are not always regulated as a pharmaceutical product.