Cleanrooms for Freeze-Drying, Pulverisation, Mixing, Filling and GMP Storage


In the cleanroom of the Lactosan Pharma plant a qualified freeze-drying plant with 60 l ice capacity is located. It features separate chambers for the product and ice condensers, adjustable standing surfaces and a closing mechanism for vials. The control and documentation takes place via a process control system.

The process takes 3 - 5 days depending on the formulation. The residual moisture content in the powder can be lowered to < 3%. The class D cleanroom is equipped with an air-drying system, which constantly control the air moisture and temperature to keep the produced powder dry.


The miscibility of the freeze-dried product is assured by grinding the lyo-beads and sieving the powder in a qualified sieve mill.


After grinding the entire batch is homogenised in a mixing barrel in a validated process.

Filling & Labelling

Lactosan Pharma fills the products in ALU-PE pouches. Pouches from 1 g to 1 kg can be manually filled. The labelling is arranged according to customer request.

GMP Storage

The storage of the packed bulk products takes place in qualified refrigerators and freezers at +4°C or -20°C.