IIR document

Freeze-drying and irradiation: promising techniques for sterilization of pharmaceutical products.

Author(s) : KUNTZ F., REY L., MAY J.

Summary

The need for sterility exists in many branches of industry such as microelectronics, medicine, and pharmaceutics of course. In the later, most freeze-dried pharmaceuticals need to be sterile. The usual rule to achieve that goal is to start with a sterile solution and, from there on, to carry out an entirely sterile process. Today all freeze-driers have their cabinets opening within a sterile room while the machinery is sitting behind the wall in the engine room. Moreover, the drying chambers are all equipped with clean-in-place systems and can be sterilized by pressure steam before each operation. Finally, those products that are prepared in vials are sealed directly within the chamber thanks to moving pressure plates that drive the stoppers tight into the neck of the vials. Facing complex mechanical setups such as semi-continuous or continuous freeze-drying seem susceptible to serious hazards in the sterility control of the operation and definitely bear on the production cost. The goal of this presentation is to propose another solution to the sterile production of pharmaceutical products.

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Pages: 2007-3

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Details

  • Original title: Freeze-drying and irradiation: promising techniques for sterilization of pharmaceutical products.
  • Record ID : 2008-2760
  • Languages: English
  • Source: New Ventures in Freeze-Drying
  • Publication date: 2007/07

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