1 Scope
This part of ISO 11040 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 ISO 11040.
NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plungers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5, and ISO 11040-6.
NOTE 2 ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.