BS ISO 11040-7:2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for the packaging system
5 Information to be provided by the manufacturer
6 Marking of the tub
7 Packaging of tubs in trading units/bundles
Annex A (informative) - Design of nests
Annex B (informative) - Determination of nest deflection
Annex C (informative) - Design of tubs
Annex D (informative) - Schematic illustrations of
        examples for the orientation of tubs within the
        protective bag
Annex E (informative) - Design and dimensions of
        the protective bag
Annex F (informative) - Test method to determine the
        distance between the edge of the protective bag
        to the rear end of the tub
Bibliography

Describes the packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.

This part of ISO11040 specifies the packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.

Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this part of ISO11040.

NOTE1 Glass barrels and sterilized subassembled syringes ready for filling, plungers, and plastic barrels for injectables are specified in ISO11040-4, ISO11040-5, and ISO11040-6.

NOTE2 ISO11607-2 addresses validation requirements of sealing and packaging processes for medical devices.