ISO 21882 discusses filling glass vials. ISO 21882 is an international standard that provides for sterile packaged ready for filling glass vials.
ISO 21882 outlines the characteristics of sterile and ready for filling empty glass vials for injectable preparations, including the minimum requirements of materials, packaging systems, and analytical test methods.
Under ISO 21882 the availability of two packaging configurations makes ready for 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.
ISO 21882 on sterile packaged ready for filling glass vials is relevant to:
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 vials.
ISO 21882 guidelines assist you with the requirements on washing, drying, lubrication, capping, crimping, plunger insertion, packaging, and sterilization for sterile packaged ready for glass vials. ISO 21882 provides requirements on material, dimensions, visible particles, sub-visible particles, and bacterial endotoxin level for glassware for glass vials.
ISO 21882 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 vials.
By adopting ISO 21882 the end-user can enhance the quality and efficiency of glass vials with proper sterilization methods for filling glass vials and the packaging to prevent any infectious substance to get in contact with filling glass vials.ISO 21882