Controlled ambient conditions in production, laboratory and storage areas ensure product quality. The cleanroom qualification verifies that the ambient conditions do not affect the product quality, or have any influence is reduced to an acceptable level.
Testo Industrial Services can offer you technical and HR support for the extensive GMP measures in the field of cleanroom qualification. We carry out all qualification tests in accordance with Annex 1 of the EU GMP guidelines, DIN EN ISO 14644 and VDI 2083. In addition to cleanroom qualification, we also carry out tests and qualifications of safety cabinets, insulators and other clean air systems.
We will support you from the conception and planning of the qualification phases (DQ, IQ, OQ, PQ), the implementation of risk management in accordance with the requirements of ICH Q9/ EU-GMP guidelines through to maintenance services and re-qualification measures. In the process, we will support you with your individual measurements or take over the complete project management.
Reproducible climatic conditions are vital in the production of sensitive products in cleanrooms.
We will support you by ensuring constant temperature and humidity values in your cleanroom:
The protection of cleanroom areas against contamination from less clean areas is ensured by a differential pressure concept with controlled overpressure. By measuring the pressure and the air flow velocity, operational safety can be increased and the quality of the products ensured.
We will support you in your qualification measurements in your cleanrooms:
Maintaining defined, cascaded overpressure chambers generates an air flow from areas of higher purity to areas of lower purity. By supplementing the pressure measurement by measuring the air flow velocity and direction of flow, operational reliability can be increased.
We will support you in your qualification measurements in your cleanrooms:
In cleanrooms, the concentration of airborne particles is one of the decisive parameters for a suitable process environment. After qualification, particle monitoring ensures that the established air quality is maintained.
We will support you in your particle measurements in your cleanrooms:
In addition to classification measurements, we carry out microbiological sampling. We will manage the entire monitoring process from planning to the final report. The limit values for this are laid down in the EU GMP Guideline, Annex 1.
Our services in the field of microbiological monitoring:
Testo Industrial Services is accredited as a test laboratory in accordance with ISO/IEC 17025 for testing in the field of qualification of cleanrooms. Testing is carried out in strict adherence to DIN EN ISO 14644, VDI 2083 and Annex 1 (EU GMP Guideline).
DAkkS has verified that Testo Industrial Services has the expertise to carry out the following cleanroom services:
Projekt Filling & Lyophilisation bei der CSL Behring GmbH Marburg
