White Room
Certified production in controlled contamination environments
Bianchi-Giavotti is equipped with two clean rooms for the molding of items in a controlled environment, both meet the requirements prescribed by the EC-GMP Annex 1 and
ISO 14644-1:2015 for the corresponding class of membership
ISO 7 and equipped with specific areas for the entry of personnel and the exit of the product.
A dedicated IT system ensures complete production traceability, from the batch of raw materials used, the press, and the operator, to the final packaging for the customer.
The molding process requires materials to be transported directly from the silos to the presses via a PLC-controlled system that uses a vacuum line.
The presses in the production department are arranged around the clean room and are all equipped with a robot for picking the pieces from the mold and then transferring them into the controlled environment.
Currently in the department there are almost exclusively electric presses from 100 to 200 tons with the sole exception of the 2 presses of 350 and 400 tons which are necessarily hydraulic.
Both the mold chamber area of the presses and the robot zone are protected by an absolute filter (laminar flow) that keeps the piece uncontaminated until packaging inside the chamber.
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