Ph. Eur. Draft Chapter 3.2.1 "Glass containers for pharmaceutical use"
A draft of a revised version of Ph. Eur. General Chapter 3.2.1 "Glass Containers for Pharmaceutical Use" has been published in Pharmeuropa 28.4. Comments regarding this draft can be submitted until 31. December 2016.
The revision includes several modifications regarding the test for Hydrolytic Resistance:
Additional details concerning the autoclaving process, with respect to equipment and handling, have been included.
A new paragraph with the title "Autoclaving process" has been added, with details regarding autoclave calibration. The validation of the calibration has to be verified from time to time based on a re-calibration plan. The use of the calibrated thermocouple is no longer necessary for routine autoclave runs provided the calibration has been demonstrated to remain valid over a well-defined time span. Specifications for using steam autoclaves equipped with a vacuum system have been introduced.
Determination of the Filling Volume - Syringes and cartridges: they can be closed using an inert material, e.g. a tip cap, or any other suitable means to prevent water leakage.
The procedure for cleaning the containers to be tested has been revised in order to result in better reproducibility.
Filling and heating: instructions have been added in order to cope with small containers of a volume of 2 mL or less, in which the water is not sufficiently retained during the autoclaving process. They may be closed in a suitable way, e.g. with a stopper or plug of inert material, such as silicone, and fixed using a plunger or a stable fixing or clamping device.
After registration on the Pharmeuropa Website you will have access to the complete draft monograph 3.2.1 "Glass Containers for Pharmaceutical Use".