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DIN ISO 21882:2020-12
Sterile packaged ready for filling glass vials (ISO 21882:2019)
| Fecha edición: |
2020-12-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies 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. In the last few years, following the more and more urgent request for ready for filling containers, packaging manufacturers managed to offer to the pharmaceutical industry containers already washed and sterilized. This category of products was born about thirty years ago with the appearance on the market of ready for filling syringes. Due to the increasing market presence of syringes "ready for filling" and the associated advantages of this product for the pharmaceutical industry, the suppliers of packaging materials started to develop systems of this type for vials. The availability of two packaging configurations makes ready for filling glass vials suitable to be used both in clinical trials and in mass production. Nest and tub configuration has been conceived to be used usually with automated filling machines, while tray configuration is usually suitable for small batches filled manually or by means of semi-automated filling machines. |
| Keywords: | Analysis|Bottles|Bottling|Bottlings|Characteristics|Cleaning|Closures|Definitions|Design|Disposable|Disposables|Drying|Filling|Glass|Glass containers|Glassware|Injection bottles|Injection containers|Injection instruments|Injection preparations|Injections|Materials|Means of packaging|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Packages|Packaging glass|Packaging material|Packaging processes|Parenteral infusion equipment|Performance requirements|Plastic containers|Prefabricated|Protection|Protective container|Quality|Quality management|Single use syringes|Specification (approval)|Sterile|Sterile barrier systems|Sterility|Sterilization (hygiene) |
| ICS: | 11.080.30 - Envases estériles |
| CTN: | |
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Equivalencia Internacional |
Idéntica ISO 21882:2019 |
|
Reemplazo Normas |
Reemplaza a DIN ISO 21882:2018-08 |
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