Overview

This part of ISO 4802 specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at 121 °C ± 1 °C for 60 min ± 1 min. The resistance is measured by titration of a known aliquot portion of the extraction solution produced with hydrochloric acid solution, in which case the resistance is inversely proportional to the volume of acid required; b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this part of ISO 4802. This part of ISO 4802 is largely based on a method of test approved by the International Commission on Glass (ICG), Technical Committee 2, "Chemical Durability and Analysis", approved test method for measuring the hydrolytic resistance of the interior surfaces of glass containers. The European Pharmacopoeia Commission has adopted the principle of the determination by titration and has set up a classification for glass containers for injectable preparations which is now included in this part of ISO 4802. In addition, this part of ISO 4802 contains a classification of containers other than for injectable preparations. According to many results of international interlaboratory tests, this part of ISO 4802 specifies the test conditions in more detail than the European Pharmacopoeia in order to increase the reproducibility of the test results. In particular, the autoclaving cycle is described in detail.

Document: references other documents

Responsible national committee

NA 176-04-04 AA - Packaging systems for loading and application of medical devices  

Responsible international committee

ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables