Abstract
This document specifies general requirements and considerations for the design of packaging used to contain cells for therapeutic use.
This document is applicable to packaging intended to contain the final products of cells for therapeutic use, as well as their starting and intermediate materials.
This document does not apply to:
a)ÌýÌýÌý receptacles used for processing cells in manufacturing processes, e.g. cell culture flask or bag;
b)ÌýÌýÌý shipping containers containing packages for transportation;
c)ÌýÌýÌý services that utilize packages, e.g. storage services.
±·°¿°Õ·¡Ìý1ÌýÌýÌý Examples of packaging, packages and shipping containers are illustrated in ´¡²Ô²Ô±ð³æÌý´¡.
±·°¿°Õ·¡Ìý2ÌýÌýÌý The design of packaging includes processes to ensure that the designed packaging is manufactured to a required specification through trial manufacturing, testing and implementation of quality management.
±·°¿°Õ·¡Ìý3ÌýÌýÌý International, national or regional regulations or requirements can also apply to specific topics covered in this document.
General information
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Status: PublishedPublication date: 2023-04Stage: International Standard published [60.60]
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Edition: 1Number of pages: 19
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Technical Committee :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 276ICS :07.080
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