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Technology
Caps which seal inside a freeze dryer
Lyoseal caps from Biocorp (Gerzat, France) have the potential to rationalize the closing process for lyophilized drugs to a significant extent. These innovative caps are sealed inside the freeze dryer itself. Not every freeze dryer is capable of performing this process – freeze dryers from Klee (Mornshausen near Marburg, Germany), an affiliate of Optima Group pharma, have already proven success in a test capacity.Improved process reliability, lower investment costs
With the Lyoseal system, pharmaceutical liquids are filled in conventional vials, onto which standard stoppers are then placed. Prior to freeze drying, the special Lyoseal caps are placed on these partially stoppered vials.
After the freeze drying process, which is performed in the standard process, the Lyoseal caps can be safely closed by pressure from above. In the freeze dyers, the motion sequences of the cooling shelves required for this process are already set up for conventional stoppering. However, proper sealing of Lyoseal caps requires more force, therefore as an option, Klee equips its freeze dryers with a hydraulic system which builds up 15% more closing pressure. This ensures that sufficient force can be applied, including additional reserve. Klee freeze dryers that are already installed can also be retrofitted for the handling of Lyoseal caps.
The Lyoseal system requires plane surfaces over the entire cooling shelves. Irregularities could potentially increase or decrease the pressure exerted on the caps. The special procedure used by Klee for the production the cooling shelves in the freeze drying chambers results in particularly plane surfaces with a tolerance of +/- 0.2mm/m. This not only ensures even temperatures during freeze drying – differences over all zones are +/- 1 Kelvin for the individual shelves - but when using Lyoseal caps in the closing process, the Klee quality of the cooling shelves offers the utmost in process reliability and product safety. Tests conducted with Klee freeze dryers under real application conditions confirmed this.
One benefit of the Lyoseal system is the significant rationalization of the closing process: An additional closing machine, including machine control and product transport is no longer required after the freeze drying, considerably reducing investment costs and processing times. On top of that, the sealing is carried out immediately after the freeze drying in a class A cleanroom environment without need for further transportation. Thus, sterility is guaranteed.
