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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.

Durchführung einer Reinigungsvalidierung in einer pharmazeutischen Prozessanlage

Cleaning validation of pharmaceutical process plants

Testo Industrial Services supported the cleaning validation of the process plants at B. Braun Melsungen AG with high flexibility and great technical know-how. A tight schedule required particularly structured and organized work.

B. Braun supplies the healthcare market worldwide with products for anaesthesia, intensive care, cardiology and extracorporeal blood treatment. An independent pharmaceutical pilot plant was established for the development and production of new innovative products. The most modern technical equipment, which reproduces the production in the later series production, serves for the development and small series production ("production in small format") of new, innovative products.

The aim of this project was the holistic handling of the cleaning validation including all development and optimization activities in the field of cleaning process.

Your advantage: Our competence

Consulting in the field of cleaning validation
Creation of a cleaning validation concept
Project management cleaning validation new pilot plant
Consulting for analytical method validation
Structuring of cleaning validation activities via superordinate master plan
Preparation of the risk analysis for cleaning validation
Process development in the optimization studies for the cleaning of complex process equipment and a dishwashing machine
Development and structuring of the sampling strategy

The result

The holistic support provided by Testo Industrial Services in the area of cleaning validation included the implementation of a risk-based validation management and the cGMP-compliant cleaning validation of the process equipment and the dishwashing machine. The processing of the requirements was flexible, fast and adapted to the project.

Probenahme mit Stäbchen aus einem Produktionsbehälter

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