Qualification of plants and utilities 

For every qualification task, from the qualification of individual devices to complex plants, GMP upgrades or new construction projects in the compliance area, we offer you the necessary know-how and additional resources. 
You receive solutions tailored to your needs with the appropriate Risk management as well as flexible time and resource planning. For optimized utilization, we also offer temporary or permanent support through our qualification engineers.

The risk-based qualification of production, filling and packaging plants plays a central role in the quality assurance of medicinal products and medical devices. Testo Industrial Services supports you in ensuring the qualified status over the entire plant life cycle - from the preparation of the risk analysis to initial qualification and requalification.

As part of the qualification, Testo Industrial Services provides proof that a clean air system (AHU) has the necessary performance capability for the application. The VENT qualification is, among other things, an integral part of the clean room qualification.

Compressed air and other sterile and non-sterile pharmaceutical gases are subject to stringent purity requirements, as any impurities are associated with high risks in terms of drug safety. We support you in the regular control of gases to ensure consistent and robust product quality. 

Testo Industrial Services supports you as a qualification service provider in all quality assurance measures in the utilities sector - from the performance of individual measurements to the complete handling of the qualification of water and water systems. 

The cleaning and sterilization 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 No.1, 29, 30 and 61 set requirements for the sterilization of production equipment and for hygiene monitoring as the basis for sterilization validation

We support are from individual measurements to complete project management: 

• Design and consulting for risk-based planning and qualification of plants, equipment and utilities 
• Qualification support across all qualification phases - DQ, IQ, OQ, and PQ 
• Structure of the risk management and implementation of risk analyses 
• Preparation of qualification documents and reports 
• Carrying out all qualification tests and measurements 
• Complete coordination of your project 

We support you in your projects and are committed to your goals. Here you will find an excerpt from the references of our successful qualification projects in the field of plants and utilities.