Sanofi Installs New Tuttnauer cGMP Production Autoclave

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.

Temperature Consistency

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.

 

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Questions & Answers

Get Answers to Your Questions

Ask any question about sterilization and autoclaving and one of Tuttnauer's experts will answer. Send your question to [email protected] with the title “Q&A.”

 

Q. Are there filters when using an autoclave and can they be cleaned via ultrasonic? (Michael, USA)

A. There are air filters, but they cannot be cleaned via ultrasonic. Rather, they have to be replaced periodically. Please consult your owner’s manual for specific instructions.

 

Q. Dear colleagues, while it is very broadly known that air in steam will reduce the sterilisation efficiency in autoclaves, I could not find quantitative data on that. Could you please point me to info how the efficiency drops with 1,5,10 & 20% air in steam? (Peter, Switzerland)

A. In general, where there is air, steam will not go. Where the steam doesn’t penetrate, sterilization cannot occur. This means we need to remove the air in order for the steam to penetrate to the deepest points of the load. For that we provide prevacuum pulses, which remove the air. By the European regulation, more than 99% of the air must be removed.

In case you are asking about non-condensable gases, which are in steam, then there are special tools for testing the quality of the steam.
 

Q. Can we keep sterilization autoclaves in my first floor multi store office, having 50 persons in the office or, what are the hazards from sterilization autoclaves, or what are guide lines for sitting in an autoclave place? (K G KAPOOR, India)

A. It depends on the biosafety of the load. What exactly are you sterilizing? If you are sterilizing instruments for medical use, then I see no biological danger. However do not forget that we are dealing with a pressure vessel. The sterilization process is done with high pressure steam inside the chamber, and it’s important to relate to this point. You should not stand in front of the autoclave door while the cycle is running. In case you are inquiring about a biosafety level laboratory (BSL), see our blog post here.

 

Q. I have been using an autoclave to sterilize empty glass bottles at work. I sterilize all size bottles from 50ml right up to 10L. I sterilize the bottles with the lid on (not too tight). This seems to work well, except for the 1L bottles. When the autoclave cycle is finished the 1L bottles look dry on the inside but after 10 mins of cooling they almost all have condensation/ water on the inside. I can't figure out why this might be and is strange considering that I sterilize different size bottles in the same load. If you have any tips I would be very grateful. (Erik, Netherlands)

A. This is because of the difference between the temperature of the chamber and the room. You can try to leave the bottles inside the chamber for a few extra minutes after opening the door.

 

Thanks for joining us for this set of Q&A’s. Please keep in mind that the questions answered here are of a general nature and may not include specific instructions for all Tuttnauer models and for all possible sterilization loads. For specific questions regarding your autoclave model or sterilization load, please contact us directly at [email protected].

 

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