THICKNESS OF THIN FILMS ON GLASS - A ROUND ROBIN TEST - REPORT OF THE INTERNATIONAL COMMISSION ON GLASS (ICG) TECHNICAL COMMITTEE 19 "GLASS SURFACE DIAGNOSTICS"

The film thicknesses of five different layer Systems on glass Substrates were analyzed and determined in a multi-method approach by eight different university and industrial laboratories. The total coating thicknesses varied between a few nm up to some 100 nm. The measurements give information about the chemical composition and cover a wide spectrum of typical coating application on glasses. The results of the different laboratories and methods are compared and the challenges and limits of the various analytical techniques are discussed

Laboratory intercomparison for the evaluation of the delamination propensity of glass containers for pharmaceutical use

This paper is the result of two round robin activities run by the Technical Committee TC12, Pharma Packaging, of the International Commission on Glass (ICG). It deals with the phenomenon of delamination, that is, the formation of lamellae or flakes in drug products due to specific and localized corrosion of glass vials, and it follows a first paper PDA J Pharm Sci Technol. 2018, 72, 553\u2013565where a testing protocol for the evaluation of the delamination propensity was proposed. The results showed that the protocol gives information on the quality of vials with respect to the propensity to corrosion, but no direct correlation with delamination could be demonstrated, as no lamellae formation was observed. In response, further testing was carried out on five sets of vials with expected low delamination propensity, compared to a set of vials with high expected delamination propensity using both the proposed protocol and a more aggressive protocol. The objective was to observe lamellae at least in the high propensity vials to show a correlation to initial test protocols. The results show that there is a very good consistency between the results of the two testing protocols and therefore, with a good level of reliability, the degree of glass surface corrosion can be estimated by the testing protocol proposed by the Technical Committee. In some cases, the glass surface corrosion results may indicate an increased risk of delamination (depending on the individual interaction between the pharmaceutical solution and the inner vial surface)

Delamination propensity of glass containers for pharmaceutical use: A round robin activity looking for a predictive test

Delamination, which is the formation of flakes in drug products owing to specific and localized corrosion of glass vials, is a rare but serious problems, on which the FDA (U.S. Food and Drug Administration) put a warning to the pharma industry in 2011. The Technical Committee (TC) TC12 of the International Commission on Glass (ICG) was created in 2012 with the aim to study the problems related to pharma packaging. The first task of TC12 was to address the problem of predicting the propensity of glass vials to delamination, leaving the study of the mechanism(s) of flake formation as a possible future activity. This paper reports on the results obtained in a round robin test, which involved all the labs of the companies represented in the TC. Five types of vials with different expected delamination propensities were tested using a protocol that includes autoclaving at 121\ub0C of vials filled with NaCl solution adjusted to pH 8 with NaOH solution, a coloration test, and ICP-OES determination of Si, B, and Al. Although there was no flake formation, the results showed that the combination of strong coloration at the bottom of the vials and high silicon concentration in the solution is correlated to an observable morphological modification/corrosion of the inner surface of vials in the bottom region. The test protocol is therefore useful for checking the quality of the vials with respect to the propensity to corrosion. Regarding delamination, no direct correlation with the testing results could be obtained yet. The method allows catching differences in the corrosion behavior, mainly between sets of vials with comparable surface: volume