rms

RMS
Tekom 1700

The system is intended for registration, archiving
and visualization of physical, ambient and electrical
parameters in ‘clean’ rooms for production
and warehousing. The measurements are taken
in accordance with GMP and GLP requirements.

The scope of the measurements:

Temperature

Relative
humidity

Pressure,
differential pressure,
overpressure

Air flow
velocity

in clean rooms

Particles quantity
in clean room

Gas
concentration

Tekom takes care of detailed and as-built designs, validation
and qualification of the devices in the scope of:

iq-en

Documented verification confirming that installation, system and devices, installed or modified, are compliant with approved project and manufacturers recommendations.

oq-en

Documented verification confirming that installation, systems and devices, installed or modified, operate in the anticipated operating ranges in accordance with the requirements of manufacturer of pharmaceutical products.

pq-en

Performance Qualification: Documented verification confirming that installation, systems and devices operate as a whole on a repetitive basis with regard to approved process and products specification.