ISO 21882:2019 PDF
Sterile packaged ready for filling glass vials
Sterile packaged ready for filling glass vials
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 20
- Дата публикации:
- 18 октября 2019 г.
- Издание:
- ISO IS 21882 edition 1 version 1
- ICS:
- 11.080.30
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.
Abstract
Overview
ISO 21882:2019 - "Sterile packaged ready for filling glass vials" defines the characteristics and minimum requirements for intended for injectable preparations. The standard addresses materials, packaging systems (sterile barrier systems and protective packaging), process controls and analytical test methods required to deliver washed, sterilized empty vials suitable for aseptic filling.
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