Multifunctional blending plant
to meet the demands of every product.
Our container blending line is officially GMP-certified in accordance with Part II of the EU GMP Guide / ICH Q7. It enables us to process non-sterile pharmaceutical excipients and intermediates.
State-of-the-art technology for perfect blends
Counter-current container blending line
The central feature of the plant is our qualified counter-current container blending line with three 2,200-litre blending containers and the relevant peripheral equipment. The latter includes a hopper mounted on load cells, a fluid-bed sifter, a flow metal detector and facilities for packaging in sacks, fibreboard boxes, drums or FIBCs. We are also pleased to carry out ordinary repackaging orders for transferring goods from one kind of container to another.
Qualified independent part of the factory
Production takes place in an independent complex of buildings with separate rooms for palletizing, weighing, feeding of raw materials, blending and filling. The entire production area is classified according to SOP “VA-0015 Hygiene Concept” as Hygiene Zone E and supplied with conditioned air via a ventilation system to ensure the required air quality. The standard for the particulate count is that of ISO Class 8 in accordance with ISO 14644-1.
Our counter-current container blending line works by the very gentle free-fall blending method. Cutting heads can be inserted if necessary to permit intensive mixing and grinding, and these can also be used for working in liquids or breaking up any lumps. Both large and small orders with batch sizes between 200 and 1,000 kg can be carried out quickly. The container blending method guarantees exact separation of the batches. Control sifting and metal detection also contribute to a very high level of safety.
Facts & figures
Powder blending technology
- GMP-certified counter-current container blending line
- 2,200-litre blending container for batches of ca. 200-1,000 kg
- Blending container with optional insertion of cutting heads
- Possibility of working in liquids through atomizing spray nozzles
- Protective sifting and metal detection
- Filling into sacks, drums, fibreboard boxes or FIBCs
- Qualified production rooms with a controlled environment
- Validated wet cleaning procedure
- Batch-by-batch documentation of setpoint/actual values in weighing
- Batch-related documentation (Batch Record Review)