We qualify your cleanroom and provide complete, GMP compliant documentation.
As a TUV certified company, we offer extensive and high-quality qualifications of all cleanroom technical appliances and equipment in accordance with all established guidelines.
Our qualified and experienced technicians and engineers work with state-of-the-art, calibrated measuring equipment and realise all phases of cleanroom qualification. All measurements are carried out in a predefined operating condition (“at rest” or “in operation”) and are documented consistently and professionally. Documentation is based entirely on preassigned, approved inspection protocols. The results will then be evaluated using a specific report.
Afterwards, you will receive a clear, complete, comprehensive and standard-compliant documentation - of course also GMP compliant using validated test plans.
In collaboration with our customers, we determine which legal standards and specifications apply in relation to the process and product.
We offer several cleanroom qualifications, including:
As a partner in consulting, planning and execution, we offer clients comprehensive documentation of your cleanroom systems qualification.
The aim of a cleanroom qualification is to verify the requirements for environmental conditions needed from a manufacturing point of view. A cleanroom qualification is an elementary component of quality assurance.
Document that details the procedure throughout the qualification process
Conducting a risk analysis.
This is the first qualification phase for checking the planning documents for conformity with the requirements of the operator (specifications) as well as the official requirements and guidelines.
This phase is used to review and define the requirements and acceptance criteria for installing a plant.
The OQ uses different measurements to verify that the installed equipment meets the requirements for the defined parameters. All measurements are carried out "at rest".
We carry out the following measurements in the context of Operational Qualification (OQ):
Air flow velocity
Determination of the air change rate
Determination of the air flow volume
Measuring the room differential pressure
Filter integrity test
Measuring the filter differential pressure
Determination of the purity class
Recovery test
Measuring the temperature and humidity
Microbiological tests and determination of the bacteria count
The PQ provides the documented proof that the plant or the device is producing under defined production parameters within specified parameters. All measurements are performed "in operation".
