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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.

Implementation of a plant qualification in the pharmaceutical environment

Qualification and calibration of pharmaceutical production facilities at a well-known vaccine manufacturer

In this project, Testo Industrial Services was involved in the qualification even during the shell construction phase of the building. Qualification documentation was prepared for all trades and completed within a tight time frame.

The plant is the "Centre of Excellence" for cell culture-based vaccines and viral vaccines for this renowned customer from the pharmaceutical industry. The main products produced at the site are influenza vaccines, tetanus/pertussis/diphtheria/rabies vaccines and vaccines against tick-borne encephalitis (tick-borne meningoencephalitis): TBE produced.

Testo Industrial Services was involved in the qualification directly after the basic engineering of the building. After the creation of the qualification concept, the qualification measures of the complete manufacturing plant were carried out. This included the execution of FAT's at the plant suppliers and the integration of the SAT documentation as well as the preparation of the qualification documentation.

Your advantage: Our competence

Qualification of plants and utilities: fermenter lines and separators, ultrafiltration, chromatography, inactivation, thermal disinfection, clean-in-place systems, ultrapure water plants, ultrapure steam plants (producers), monitoring systems (rooms), autoclaves
Cleanroom qualification: filter leak test, determination of recovery times, determination of cleanliness class, volume flow rate and air exchange rate
Calibration: temperature, relative humidity, pressure, mass flow, level (mass), conductivity, PH value, oxygen saturation, rotational speed

The result

Within a period of three years, the qualification measures of the complete manufacturing plant were carried out, including the execution of FATs at the plant suppliers and the integration of the SAT documentation. The use of a large number of highly accurate measuring systems as well as experienced personnel enabled a high degree of flexibility in the processing of the qualification plans.

Consulting for the qualification of a pharmaceutical ventilation system

More about our services

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

Checking a HEPA filter for leaks

Cleanroom qualification

Security and compliance for your cleanrooms

Carrying out the on-site calibration of a ventilation system

On-site calibration

Overcoming distances and reducing downtimes