Klee freeze dryers seal Lyoseal caps.[ILLUSTRATION OMITTED]
Lyoseal caps from Biocorp (Gerzat, France) have the potential to rationalize the closing process for lyophilized ly·oph·i·lize
tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es
To freeze-dry (blood plasma or other biological substances).
[lyophil(ic) + -ize. 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 successful in testing.
With the Lyoseal system, pharmaceutical liquids are filled in conventional vials, onto which standard stoppers stoppers
see stopper pad. are then placed. Prior to freeze drying freeze drying,
n the freezing of heat-sensitive liquid materials in a vacuum to preserve the characteristics of the substrate and remove the volume of water or liquid by sublimation. , the special Lyoseal caps are placed on these partially stoppered stop·per
1. A device, such as a cork or plug, that is inserted to close an opening.
2. One that causes something to stop: a conversation stopper.
3. vials. After the freeze drying process, which is performed in the standard way, 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 Noun 1. hydraulic system - a mechanism operated by the resistance offered or the pressure transmitted when a liquid is forced through a small opening or tube that 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 kelvin, abbr. K, official name in the International System of Units (SI) for the degree of temperature as measured on the Kelvin temperature scale.
A unit of measurement of temperature. 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 Those program costs required beyond the development phase to introduce into operational use a new capability; to procure initial, additional, or replacement equipment for operational forces; or to provide for major modifications of an existing capability. and processing times. On top of that, the sealing is done immediately after the freeze drying in a Class A clean room environment without the need for further transportation. Thus, sterility is guaranteed.
FOR MORE INFORMATION
Sabine Gauger GAUGER. An officer appointed to examine all tuns, pipes, hogsheads, barrels, and tierces of wine, oil, and other liquids, and to give them a mark of allowance, as containing lawful measure.
OPTIMA Packaging Group GmbH
Tel. +49 791 506 1410