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Qualification of systems & utilities by Testo Industrial Services

Ensures process stability and robustness

Qualification of systems & utilities

Qualification

Qualification of systems & utilities

HVAC systems, process gases, sterilisers, water and water systems

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:

  • Commissioning and control engineering calibration of ventilation systems and distribution systems
  • Carrying out the qualification tests
  • Determination of air volumes and climatic conditions
  • Carrying out all tests as part of the installation qualification of the ventilation components
  • Calibration of all test-related measuring points
  • Testing of the hygiene requirements for VAC systems according to VDI 6022
Calibrationof VAC systems by Testo Industrial Services

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.):
 

  • Particle content testing
  • Determination of the microbial status
  • Checking the oil content
  • Determination of moisture or pressure dew point
  • Risk-based qualification of all system components
  • Planning of routine monitoring
Checking of process gases by Testo Industrial Services

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):

  • Calibration of all measuring points for temperature, pressure, flow rate, conductivity, and pH value
  • Preparation of the risk management and qualification concept
  • Planning of 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 re-qualification measures
  • Support in OQ and PQ phases including verification of all key chemical and microbiological parameters
Checking of Water and water systems by Testo Industrial Services

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:
 

  • Qualification, including all qualification measurements of autoclaves, steam sterilisers, hot air sterilisers and tunnels, depyrogenation ovens, GT systems, fermenters and separators within the scope of sterilisation validation
  • Qualification, including all qualification measurements, for example, of dishwashers and CIP systems within the scope of cleaning validation
Testing of sterilisation and cleaning systems by Testo Industrial Services

Qualification of systems & utilities

Our service to you


We will support you in single measurements through to complete project management:
 

  • Concepts and consulting for risk-based planning and qualification of systems, equipment and utilities
  • Qualification support across all qualification phases - DQ, IQ, OQ, and PQ
  • Development of risk management and implementation of risk analyses
  • Preparation of qualification documents and reports
  • Execution of all qualification tests and measurements
  • Complete coordination of your project

More assurance, better service for your GMP compliance

What sets us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with more than 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Qualification of systems & utilities

Our references

Qualification of systems & utilities

Further information

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