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 |