| Name | Support | Language | Availability | Edition date | Price | ||
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PDF |
English |
Active |
4/12/2023 |
€89.00 |
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Details
This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling.
This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.
"Directives : Not yet available in DB
Additional Info
| Author | Bureau de Normalisation Belge (NBN) |
|---|---|
| Published by | NBN |
| Document type | Standard |
| ICS | 11.120.99 : Other standards related to pharmaceutics
55.020 : Packaging and distribution of goods in general |
| Document history | No |
| Keyword | ISO 23416, ISO 23416:2023 |
