What is ISO 21881 – Sterile packaged ready for glass cartridges about?
ISO 21881 discusses Sterile packaged ready for filling glass cartridges. ISO 21881 is an international standard that provides for the filling of empty glass cartridges.
ISO 21881 specifies the characteristics of sterile packaged ready for glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems, and analytical test methods.
Under ISO 21881 the availability of two packaging configurations makes ready for the filling glass cartridges suitable for use both in clinical trials and in mass production.
The duality of packaging configurations calls for standardization of the production processes,
materials quality and analytical methods when launching these products on the market, to avoid conceiving too highly customized processes.
Who is ISO 21881 – Sterile packaged ready for glass cartridges for?
ISO 21881 on sterile packaged ready for glass cartridges is relevant to:
- Glass cartridges manufacturer
- Test centers for glass cartridges for medical purposes
- Medical laboratories
- Regulatory authorities
Why should you use ISO 21881 – Sterile packaged ready for glass cartridges?
In the last few years, more and more urgent requests for ready for filling containers is increasing due to which the packaging manufacturers managed to offer to the pharmaceutical industry containers that are already washed and sterilized. This category of products was born about 30 years ago with the appearance on the market of ready-for-filling syringes. So, the suppliers of packaging materials have started to develop such systems of this type for cartridges.
ISO 21881 guidelines assist you with the requirements on washing, drying, lubrication, capping, crimping, plunger insertion, packaging, and sterilization for sterile packaged ready for glass cartridges. ISO 21881 provides requirements on material, dimensions, visible particles, sub-visible particles, and bacterial endotoxin level for glassware for glass cartridges.
ISO 21881 also provides requirements on nest and tub configuration, tray configuration, insert liner, sealing lid, protective bag, information to be provided by the manufacturer for packaging systems for glass cartridges.
By adopting ISO 21881 the end-user can enhance the quality and efficiency of proper sterilization methods for filling glass cartridges and the packaging to prevent any infectious substance to get in contact with filling glass cartridges.
