The risk-based qualification of your processing systems, supply systems and utilities ensures long-term process stability and robustness. Testo Industrial Services will support you in your qualification projects or handle the management of the whole process. From the qualification of individual devices to complex systems, GMP upgrades or new construction projects in the field of compliance, we can offer you the expertise and additional resources you need.
For every qualification task, we will provide you not only with solutions tailored to your needs, but also appropriate risk management along with flexible scheduling and resource planning. In addition, we can offer temporary or permanent support from our qualification engineers to optimise capacity utilisation.
Within the scope of qualification, Testo Industrial Services will provide verification that a clean air technology system (VAC) has the capacity required for the application. The VAC qualification is one of the integral parts of the cleanroom qualification.
Measurements & tests of your VAC systems:
Compressed air and other sterile and non-sterile pharmaceutical gases are subject to high purity requirements, as any impurities are associated with high risks with regard to drug safety. We will support you in the regular checking of gases to ensure constant, robust product quality.
Measurements & tests of your process gases (according to ISO 8573, Ph.Eur.):
As a qualification service provider, Testo Industrial Services will support you in all quality assurance measures in the field of utilities – from the performance of individual measurements to the complete handling of the qualification of water and water systems.
Measurements and testing of your water systems (according to Annex 1, Ph. Eur. and VDI 2081/Sheet 13):
The cleaning and sterilisation of production equipment plays an essential role in quality assurance. The standards DIN EN 285, DIN EN ISO 14937, DIN EN 13060 and DIN EN ISO 17665 and Annex 1 of the EU GMP guidelines, as well as PDA Technical Reports numbers 1, 29, 30 and 61, set out the requirements for the sterilisation of production equipment and hygiene monitoring as the basis for sterilisation validation.
Measurements and testing of your sterilisation and cleaning systems:
We will support you in single measurements through to complete project management:
