Sanofi is a global healthcare leader that transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes, cardiovascular solutions and consumer healthcare. In order to stay on the forefront of new technology and developments in the healthcare industry, Sanofi scientists must have the right sterilization tools in their pharmaceutical production labs.
Tuttnauer France recently teamed up with Sanofi to install a specially designed autoclave that uses the advanced Glass Test sterilization technology to help avoid Alkali transfer to liquids, syringes and all medicine found in glass containers. This proprietary Glass Test sterilization cycle technology that was developed by Tuttnauer meets the European Pharmacopoeia 9th edition standard.
Sanofi Installs Autoclaves Compliant with European Pharmacopoeia 9th Edition
The goal of a Glass Test Cycle is to test the degree of alkali release in pharmaceutical glass items, such as vials, that are intended to hold medicinal products. This helps avoid undesired changes in pH or ionic strength of the solution that can be important in maintaining the efficacy or stability of sensitive product formulations. The Glass Test Cycle is a process that measures the Alkali release rate from glass items during autoclave cycle, by measuring the discharge of OH- (Acidity Levels). The glass test cycle evaluates the hydrolytic stability of the containers under more severe conditions.
How Is the Glass Test Cycle Performed?
A glass container is filled with distilled water close to capacity and placed in an autoclave. The temperature is gradually raised at a linear rate to 100°C and maintained at this level for 10 minutes. After 10 minutes at 100°C the temperature will rise at a linear rate of 1 degree per minute to sterilization temperature (121°C) and remain at this level for one hour. During the cooling stage, the required temperature drop is at a linear rate of half a degree per minute. After cooling to room temperature, the water is titrated with acid to evaluate the pH level, and therefore the equivalent amount of alkali extracted during the heat cycle. The Glass Container should be taken out of the autoclave at 100°C.
It is important to sustain temperature consistency uniformly throughout the autoclave when sterilizing Glass Containers containing liquids for pharmaceutical production. This requirement is part of the European Pharmacopoeia 9th Edition standard. Tuttnauer’s autoclave technology that performs the Glass Test cycle ensures that the efficacy of the medicine is preserved during sterilization and that the risk of interaction with packaging is significantly reduced to meet the EP9 standard.