Pharmacopoeial revisions emphasise the importance of autoclave validation
UK-based Glass Technology Services, has welcomed stricter analytical requirements under the revised European Pharmacopoeia, which aims to improve the accuracy and reproducibility of hydrolytic resistance tests performed on glass primary packaging for pharmaceutical use.
In recent years, revisions to the United States and European Pharmacopoeias have seen increased harmonisation between the two monographs, including both the surface/whole article and glass grains/powder tests and an increasing emphasis placed upon the importance of assessing glass delamination risk.
A number of industry studies identified significant variations in the concentration of extracted elements analysed when performing the hydrolytic resistance glass surface test. These variations were attributed to differences in autoclaving procedures and have been addressed with the introduction of stricter requirements for autoclaves, including tight control over the thermal cycle, temperature monitoring and both calibration and validation requirements. These changes came into effect in January 2019 with the implementation of version 9.6 of the European Pharmacopoeia (Pharmacopée Européenne).