Dangerous volatile APIs?

Dangerous volatile APIs?

April 9, 2019

Volatile API compounds are the most sensitive components in the process of drying. The effect of drying on the composition these products has been the subjects of numerous studies, which show that the changes in the concentrations of the volatile compounds during drying depend on several factors, such as the drying method and drying conditions (temperature, air velocity, relative humidity).

Although freeze-drying is the best drying method, increasing the pressure in the drying chamber considerably raised the release of volatile compounds and this can generate loss of product, a sticky final result and/or general contamination.

 

Teclen® Lyoprotect®Tray with Halar® coating is designed for freeze-drying in the pharmaceutical production of APIs to avoid sticky product and volatile loss.

 

 

 

 Teclen® Lyoprotect®Tray – 2 important features!

  • The inside of the tray is coated with the thermoplastic fluoropolymer Halar®: this thick powder coating ensures outstanding chemical resistance and all components of the tray can also be individually sterilized in an autoclave.

 

  • During sublimation, the vapor can escape smoothly via the hydrophobic membrane. Freeze-drying process parameters determined Teclen® Lyoprotect® Tray with Halar® Coating for Freeze-Drying with an open container can be transferred and lead to nearly the same drying results, so that recipes do not need adjustments. Obviously, same filling level has to be applied into the trays. The membrane is designed for single use and can easily be replaced before every new drying cycle.

 

 

In combination with the membrane, the tray protects the pharmaceutical product, e.g. an API, as well as the working environment and operator against contamination.

 

Design Features and Material

• Bacteria-proof container with vapor permeable membrane

• 100% visual inspection of membrane and components

• Components comply with the regulations for materials and articles intended to come into contact with food according to (EC) No 1935/2004 and (EU) No 10/2011
• Lyoprotect® Membrane expanded PTFE on polypropylene non-wovenbacking material

• Tray Aluminum AlMg 4.5 Mn; universal alloy for engineering and construction; inside coated with Halar®

 

 

 

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