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- Calibration
  
  We are one of the leading calibration laboratories in Europe and accredited for more than 300 calibration procedures according to ISO/IEC 17025:2017.
  Calibration
- Our measured variables
  Our accredited laboratories cover almost all measurands and offer a unique service portfolio.
- On-site Calibration
  We calibrate test equipment and measuring points at our customers' sites with professional competence and high-precision equipment.
- Calibration equipment
  With our portable calibrators for temperature, humidity and pressure, calibrations can be carried out regardless of location.
- Test equipment management
  
  We manage your test equipment with the holistic test equipment management solution PRIMAS for compliance with standards and directives.
  Test equipment management
- PRIMAS online
  The internet-based test equipment management system PRIMAS online supports the assurance of test equipment requirements - even while on the road.
- PRIMAS validated
  PRIMAS validated is a validation-enabled test equipment management system for companies with GxP compliance requirements.
- PRIMAS exchange
  PRIMAS exchange enables automated data transfer of test equipment data between MES/CAQ systems and our data master.
- PRIMAS connect
  PRIMAS connect is a web service for automated access and queries to PRIMAS online in the Testo Industrial Services data system.
- Qualification
  
  We support qualification projects such as cleanroom qualification or plant qualification. We also qualify warehouses and transport systems according to GDP and GSP standards.
  Qualification
- Qualification of cleanrooms
  Professional support for all GMP measures in the area of cleanroom qualification - from conception to implementation.
- Qualification of plants and utilities
  Risk-based qualification of process plants, supply systems and utilities for sustainable safety of process stability and robustness.
- Transport and storage qualification
  Storage and transport qualification to ensure uniform temperature and climate conditions and maintain product quality.
- Validation
  
  We take care of cleaning, process and transport validation as well as computer and software validation to ensure reproducibility and robustness.
  Validation
- Cleaning validation
  Holistic handling of professional cleaning validations as well as support for validation projects and revalidation measures.
- Process validation
  Risk-based process validation to demonstrate the fulfilment of process requirements and outcomes, and to ensure product quality.
- Transport validation
  Transport validation to ensure stable climate conditions during logistics and transport of sensitive goods to the consumer.
- Computer and software validation
  Computer and software validation (CSV) to ensure the reproducibility of procedures and processes of computer-based systems.

Sterile filling line at CSL Behring GmbH

Qualification of a sterile filling

For CSL Behring GmbH Testo Industrial Services took over the clean room qualification as well as the qualification of ventilation systems, autoclaves, freeze drying systems, filling line as well as the incubation rooms.

CSL Behring is one of the world's leading manufacturers of plasma derivatives. The company supplies the world market with its products and produces almost one fifth of all plasma based drugs worldwide.

As part of the "Filling & Lyophilisation" project at CSL Behring GmbH in Marburg, new filling lines were set up for the production of coagulation preparations and preparations for wound healing. With the ventilation systems (HVACs) and the subsequent filter systems, a total of over 1,000 m² of clean room space was created for production. The cleanroom classes range from A to D.

Testo Industrial Services was commissioned with all work in the area of plan preparation and its processing within the scope of the qualification. The measures covered both the integration of the FAT and SAT documents supplied by the manufacturer and the customer specific preparation of the qualification documentation (IQ, OQ, PQ). In the project, both the clean rooms/ventilation systems and the entire process technology were qualified.

Your advantage: Our competence

Carrying out measurements as part of cleanroom qualification: Filter leak test, volume flow, flow velocity, room air exchange, recovery time measurement, rel. humidity & cleanroom classes
Qualification of ventilation systems incl. integration and testing of SAT documents
Qualification of the autoclave technology (IQ/OQ/PQ) incl. validation of the loads/programs
Qualification of the freeze drying plants (GT plants)
Qualification of a filling line as well as support of the validation of the filling process (PQ)
Qualification of the incubation rooms

The result

The qualification of the clean rooms/ventilation systems and the entire process technology of the new filling lines was adapted to the project. The use of experienced personnel and flexible equipment planning ensured that everything ran smoothly.

Qualification measurements of an autoclave

More about our services

Checking a HEPA filter for leaks

Cleanroom qualification

Security and compliance for your cleanrooms

Execution of a qualification measurement at a production plant in pharmaceutical manufacturing area

Qualification of plants and utilities

Risk-based qualification of air handling units, process gases, sterilisers, water and water systems

Service portfolio of Testo Industrial Services GmbH

Service portfolio

Your partner for calibration, test equipment management, qualification and validation