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- Calibration
  
  We are one of the leading calibration laboratories in Germany and accredited for more than 300 calibration procedures according to DIN EN ISO/IEC 17025:2018.
  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 PRIMAS test equipment management solution for compliance with standards and directives.
  Test equipment management
- PRIMAS online & mobile
  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
- Cleanroom
  Professional support for all GMP measures in the area of cleanroom qualification - from conception to implementation.
- Plants & Utilities
  Risk-based qualification of process plants, supply systems and utilities for the sustainable safety of process stability and robustness.
- Transport and storage
  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 Software Validation
  Computer system validation and software validation (CSV) to ensure the reproducibility of procedures and processes of computer-based systems.

Biotechnologische Wirkstoffproduktion bei der Firma Merz Group Services

Cleaning validation

For Merz Pharmaceuticals, Testo Industrial Services took over the structuring and processing of the cleaning validation activities within a tight schedule. Complex cleaning processes were developed and implemented especially for this purpose.

Merz Pharmaceuticals is an innovative pharmaceutical company with a focus on the research and marketing of drugs for the treatment of neurological and psychiatric diseases. The site in Dessau-Roßlau is used for the production of a parenteral drug containing a highly active biological agent.

The aim of this project was the holistic handling of the cleaning validation including all development and optimization activities of the cleaning process in the field of active ingredient production. Throughout the production process, various plant parts, tools and equipment come into contact with the highly active protein, which necessitated cleaning validation adapted to the process requirements. In the further course of the project, the service life validation was connected.

Your advantage: Our competence

Holistic handling of the project cleaning validation active substance production (planning, sampling, documentation)
Implementation of a 2-day workshop on the topic of "cleaning validation"
Consulting activities
Creation of a higher-level validation master plan
Carrying out risk analyses (matrixing, limit value calculation, sampling, analysis, etc.)
Retrospective qualification of the dishwasher (IQ, OQ, PQ)
Activities for the subproject of the service life validation

The result

Merz Group Services GmbH was fully supported in the area of cleaning validation. Thanks to the risk-based validation management and the cGMP-compliant cleaning validation of the process areas, the facility was finally approved by the FDA.

Probenahme mit Stäbchen bei der Reinigungsvalidierung

More about our services

Durchführung einer Reinigungsvalidierung in GxP-regulierten Bereichen

Cleaning validation

Purity is verifiable - verified effectiveness and reproducibility of cleaning processes

Durchführung und Dokumentation einer Reinraumqualifizierung

Qualification

GMP-compliant qualification of cleanrooms, facilities & utilities, transport & storage

Kalibrierung eines Sensors in einem Tauchbecken

Service portfolio

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