Compact Monitoring Technology – GMP monitoring to validate environmental parameters in life science industries
Compact Monitoring Technology (CMT) is a standardized solution for GMP monitoring and validation, complying with the strict requirements of the life science industry. With CMT, you can monitor, store and document up to 100 GMP-relevant environmental parameters – whether temperature, humidity, air velocity, air pressure or air particles or access to quarantine areas or access to highly sensitive medical systems like thrombocyte separators.
GMP monitoring with CMT allows you to prove that parameters that can influence product quality or the health of patients are within limits. This lowers your validation costs.
Intelligent monitoring unit for validation
CMT consists of a compact monitoring unit: a preconfigured stainless steel control cabinet with IP55 protection. A door contact on the housing protects CMT from being accessed by unauthorized persons. A temperature sensor, a fan and an optional uninterruptible power supply are integrated into the housing to ensure the operation of GMP monitoring. The monitoring unit is connected to the local IT network via a 5-port Ethernet switch and can be operated from any computer.
Integrated components for the validation and GMP monitoring functionalities:
DDC controller – for data collection and data storage
I/O module – for 34 secure datapoint connections (temperature sensor, humidity sensor and differential pressure sensor as well as particle counter)
Data processing center – e.g. for data conversion, report and chart creation, data archiving, alarm triggering, etc.
Hard disk drive (approx. 128 GB) – to store and archive critical measurement data and parameters
Three integrated signal lamps – green (everything is ok), yellow (warning), red (alarm)
Optional 19-inch touch panel – for on-site operation
For GMP monitoring, precise and certified sensors are connected to the monitoring unit. They continually measure all process-critical and quality-relevant environmental parameters. CMT lets you know when the sensors have to be recalibrated.
Applicable for regulated and non-regulated areas
Because CMT is audited according to the strict international regulations of the life science industry, it is ideal for GMP monitoring for validation in regulated markets, e.g.:
CMT can also be used to safeguard sterile environmental conditions and to protect products from contamination in non-regulated areas, e.g.:
Intensive care units
CMT – your benefits
Verifiable compliance with regulations – monitoring and storage of up to 100 GMP-critical environmental conditions, creation of trends and reports, warnings and alarms if values are exceeded
Reduced validation expenses – through preconfiguration of CMT according to GAMP 5 V-model, pretests based on FAT and simple monitoring of the processes and building areas that have to be validated
High data security – access only for authorized users, regular backups as well as meeting international regulations and guidelines for data security
Reliable operation – protection against power failures thanks to optional uninterrupted power supply
Straightforward operation – no additional training needed, since the same solution is used for BACS and GMP monitoring