The reliable qualification and operation of technical facilities also requires the use of calibrated measuring equipment for comprehensive measurements on production and supply installations. This takes place for the first time in the context of the initial qualification and repeatedly in the course of regular preventive maintenance and requalification.
Calibration and measuring technology services provided by gempex ensure that this is carried out and documented in compliance with rules and regulations.
Measuring – Correctly and the Right Things
The results of the qualification and process control are only valuable and informative if the right measuring equipment critical for quality works reliably and measures the right things. Reconciliation with a standard that can be traced back to a primary standard, a calibration that ensures the accuracy of measuring equipment. gempex offers calibration services for the following measurements:
- differential pressure
- air speed
- rotation speed
Test Planning and Execution from one Source
gempex not only provides support for the preparation of detailed test plans in the course of qualification and requalification, but also performs these tests itself. This ensures that the tests described in the test plans are actually feasible. Not necessarily a matter of course! The measuring technology that is offered focuses on these areas:
Clean room measurements according to ISO 14644 with:
- performance data and ventilation number determination
- temperature and relative humidity measurement
- differential room pressure measurement (positive and negative pressure)
- filter integrity test (DEHS test)
- clean room classification according EN ISO 14644-1, GMP/EC guideline and VDI 2083 Sheet 1
- recovery test
- microbiology monitoring (active and passive sample collection procedure)
- pressurised gas qualification (microbiology and particulate)
- sound level measurement
- lighting intensity measurement
Temperature mapping and temperature studies to assess the stability, distribution or gradient of temperatures in:
- normal temperature, refrigerated and deep-freeze storage
- technical equipment such as refrigerators and heating chambers
- vehicles and transport boxes for transport validation/transport verification
Evaluation and Assessment of the Temperature Studies
Not only does gempex provide the measurement results, but also offers their evaluation in regards to GMP and GDP requirements. Because they have to be interpreted in view to the customer’s specific requirements in order to provide proof of compliance. Full service based on broad expertise.
Proven, Secure Storage of Measuring Equipment
All measuring and test equipment that is used is consistently maintained and stored by a test equipment officer. It is calibrated at regular intervals, with additional qualification as needed, including relevant documentation and certificates. Before and after use the equipment is proved with view to regulatory requirements and again this testing is documented. All quality certification documents are included with the customer test documentation in the form of certified copies – GMP compliance.
Since 2016, gempex is performing its calibrations and measurements in close cooperation with BSR, thereby significantly expanding the offering – especially for clean rooms.
- test documentation and execution from one source
- calibration and measurement according to applicable standards, GMP-compliant
- raw data recording, test reports and test equipment certificates according to customer and legal requirements
- certified, modern measuring technology
- experts specialised in execution