ISO 11040-7:2015
Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
ISO 11040-7:2015 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 ISO 11040-7:2015.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for the packaging system
4.1 General
4.2 Nest
4.3 Tub
4.4 Insert liner
4.5 Sealing lid
4.6 Protective bag
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
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for the packaging system
4.1 General
4.2 Nest
4.3 Tub
4.4 Insert liner
4.5 Sealing lid
4.6 Protective bag
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