Freeze-Drying

General

In the pharmaceutical-compatible cleanroom of the Lactosan Microbial Additives plant 12 lyophilisators are available, which each have an ice capacity of 90l. These are 2 chamber lyophilsators and they are managed with a process control system. Lyophilisation is the gentlest way to dry bacteria and this method can be used for all bacteria produced at Lactosan.

The process takes 2 - 5 days depending on the sensitivity of the strain. The residual moisture content in the powder is < 3%. The cleanroom is equipped with an air filter system, which constantly controls the air moisture and temperature to keep the produced powder dry.

Process Steps

Freezing according to optimised time, temperature limit values

Freeze-drying (sublimation) according to time, temperature, pressure limit values

Subsequent drying of products according to time, temperature limit values

Drying Process

Every equipment used in the cleanroom needs to be chemically cleaned with an industrial washer and thermally sterilised. For each bacteria concentrate the ideal drying process has been developed. Our specialists control this process around the clock. After drying the sieving and pulverisation takes place.

Capacities

Manufacturing	Pilot Plant
1000 l / batch	60 l / batch

Further Steps

The individual powders of the lyophilisation chambers are mixed to the batch and then samples are taken. The storage of the highly concentrated strain takes place at -20°C until the analysis has been completed. Then the packaging starts.