Decontamination pass box Pass-boxes

for clean rooms

Completely compact equipment for the entry of raw materials from the clean room of lower classification to the higher classification, by means of a surface biodecontamination system by H2O2 cold nebulization. It has a chamber with a volume of 2m3 where 3 double levels of trays are loaded with the product to be decontaminated, the loading is done by means of transport carts adapted to the equipment. The system has several operating cycles depending on the stage of the process: resting, conditioning, injection, exposure, aeration or tray return. Each chamber is equipped with the necessary elements to maintain the B classification according to GMP and the pressure differential continuously, as well as the temperature and humidity necessary for decontamination. The doors of the chambers are equipped with pneumatic seals to guarantee watertightness. Manufactured 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.