Qualification of plants and utilities
The risk-based qualification of your process plants, supply systems and utilities ensures long-term process stability and robustness. We support you in your qualification projects or take over the complete handling.
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
Production, filling and packaging equipment
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.
Measurements and tests of your process plants:
- Preparation of the risk analyses and conceptual design of the qualification activities
- Carrying out all qualification tests and providing equipment
- Preparation of qualification plans and reports
- Implementation of requalification measures
- Calibration of all quality-relevant measuring points
VENT systems
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.
Measurements & tests of your air handling units:
- Commissioning and control engineering calibration of ventilation systems and distribution systems
- Conducting the qualification tests
- Determination of air volumes and climate conditions
- Carrying out all tests as part of the installation qualification of the ventilation components
- Calibration of all test-relevant measuring points
- Testing of hygiene requirements for air handling units according to VDI 6022
Process gases
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.
Measurements & tests of your process gases (acc. to ISO 8573, Ph.Eur.):
- Testing of the particle content
- Determination of the microbial status
- Checking the oil content
- Determination of humidity or pressure dew point
- Risk-based qualification of all plant components
- Conceptual design of the routine monitoring
Water and water installations
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.
Measurements & tests of your water systems (according to Annex 1, Ph. Eur. And VDI 2083/sheet 13):
- Calibration of all measuring points for temperature, pressure, flow, conductivity, pH value
- Preparation of the risk commitment and qualification concept
- Conceptual design of the routine monitoring
- Microbiological tests
- Risk-based qualification of the water system
- Preparation of qualification plans and reports
- Execution of qualification tests (IQ, OQ & PQ) and, if necessary, integration of manufacturer tests
- Implementation of requalification measures
- Monitoring of OQ and PQ phases incl. checking of all chemical and microbiological lead parameters
Sterilization and cleaning 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.
Measurements and tests of your sterilization and cleaning equipment:
- Qualification incl. all qualification measurements of autoclaves, steam sterilizers, hot air sterilizers and tunnels, depyrogenation furnaces, GT plants, fermenters and separators within the scope of sterilization validation
- Qualification incl. all qualification measurements of e.g. dishwashers and CIP systems within the scope of cleaning validation
Our service for you
We support you for 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
Your advantage: Our competence
- Expertise: Consulting, measurements, project management - our industry-experienced team supports you precisely & in line with your needs
- Technology: The use of our measuring equipment with more than 4,500 references ensures reliable measurement and test results
- Documentation: The documentation in the audit-proven layout or individually according to customer requirements will be handed over to you personally upon completion of the order
GxP-Services-Team
Professional competence, experience and high-precision equipment. The engineers and technicians of our GxP-Services Team are on duty for you throughout Europe
Success stories
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.
CSL Behring GmbH, Marburg
Qualification of a sterile filling
Grünenthal GmbH, Aachen
Qualification of a tablet line
Jäger GmbH, Muggensturm
Pharmaceutical process plants
