The KÖGEL FILTER- LYOSAFE® System

The KÖGEL FILTER- LYOSAFE® System is used in the GMP production of active pharmaceutical ingredients (API).
 
Essentially, the LYOSAFE® System consists of two main components, the stainless steel tub system with filter holder for feeding in the lyophilisate and the particle- free and sterilized LYOSAFE® ePTFE- Membrane- Filter- Cloth. The filter protects the API from cross- contamination by foreign particles during freeze drying.

Our LYOSAFE® stainless steel tub is a reusable system that can be used economically and sustainably in multi- component production according to GMP. The surfaces that come into contact with the product are electropolished and can therefore be cleaned very easily. In addition, the LYOSAFE® stainless steel tub can be sterilized.

Compared to conventional systems, the LYOSAFE® makes ecological sense because it significantly reduces plastic waste. Our stainless steel tub can be individually, technically designed and dimensioned at the customer's request. The design is based on the shelf sizes of the various freeze dryers.
 
Our LYOSAFE® ePTFE- Membrane- Filter- Cloth is chemically very resistant and can be used against all organic solvents. The ePTFE- membrane can be used without hesitation in multi- purpose- production. Only one filter medium needs to be qualified and validated for the large number of customer products. The ePTFE- Membrane- Filter- Cloth can be supplied with pore sizes of 0.20 µm, 0.45 µm and 1.00 µm. The small pore size offers product protection, but also enables high air permeability for vapor flow.

Using the KÖGEL FILTER CLEANING PROCEDURE results in a particle- free filter membrane. After cleaning, the filter are packaged sterile and then ETO- sterilized. The entire manufacturing process takes place under ISO 7 clean room conditions. Our customers can use the particle- free, sterilized filter directly in the process. The time- consuming cleaning, disinfection or sterilization of the filter by the customer is therefore no longer necessary. Potential sources of contamination can be significantly reduced.