ON OTOMASYON SİSTEMLERİ
VALIDATION AND MONITORING SYSTEMS
                                                    
On Otomasyon provides packape solutions in pharmaceutical sector by combining projest management, system analysis\data transfer cGMP compliance services, validation*,documentation services for with building maragement and monitoring systems.


Field equipment within the scope of monitoring and/or management systems should be properly selected according to related process.During the transmitter and sensor selection, particular attention has been paid on accuracy, measuring range,ease of field calibration,correct calibration, mounting criterias through On. Otomasyon know-how and experience.


Field equipment, DDC units and soltware are being supplied from the internationally well-known manufacturers in pharmaceutical applications. Therefore, the systems to be built,be come validatable.


The offered solutions for pharmaceutical production and warehouse areas,cover the delivery of monitoring,recording of parameters,alarm and analysis/repording functions to facility managers.The folowing parameters are foung very important to monitor and record through international regulations for quality assurance departments;

Temperature, Static Pressure, Absolute Humidity, Relative Humidity, Dew Point Temperature, Mean Kinetic Temperature (MKT)


Monitoring and recording of these parameters are kept in parallel with FDA 21 CFR Part 11 regulation, system establishment and validation services are realized according to GEP and GAMP 4.0.


Applications we offer as validated monitoring,recording and management systems;


HVAC Monitoring and Management Systems Pharmaceutical Warehouse Monitoring Systems Stability Room Monitoring Systems

Cold Room, Refrigerator and Freezer Monitoring Systems


Pharmaceutical Laboratory Monitoring Systems Calibration Laboratory Monitoring Systems


Solvent Storage Area Monitoring Systems (Ex-proof and Instrically Safe Instrument Application]


Autoclave, Incubator, Oven Monitoring Systems Clean Room Monitoring Systems

 
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