Totally compact equipment for the output of Finished Product and Waste from the clean room of higher classification to one of lower classification.
General characteristics
The upper part is intended for the output of finished product and the lower part for waste, the equipment consists of a first Class B chamber and then a Class C chamber.
Each unit is equipped with an automatic finished product transfer system with a transferable load of 120kg and a waste transfer system with a load of 50kg.
These chambers are separated by an automatic intermediate door and are equipped with the necessary elements to maintain the B and C classification according to GMP and the pressure differential.
Manufactured entirely in AISI-304 and AISI-316 stainless steel with a vibratory polished finish meeting the highest standards of the pharmaceutical industry.
It has a technical area on one side that facilitates maintenance work.
It consists of 2 totally independent SAS units that meet the requirements of GMP and ISO 14644 standards, as well as RD 1215/1997.
The control system is fully automatic, provided with HMI screen and PLC control connected to a SCADA system.
The control system has been designed, manufactured and validated according to GAMP 5 and Annex 11 GMP.
Electronic records comply with 21 CFR Part 11.