Jump to content

- 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.

Qualification of pharmaceutical process plants

Qualification of pharmaceutical process plants

Testo Industrial Services took over the GMP compliant qualification of the process plants of the entire production area for Jäger GmbH and integrated the qualification documentation into a cross company qualification master plan.

As an innovative contract manufacturer, Jäger GmbH produces and packages products for well-known cosmetics and pharmaceutical companies. The production of several galenic forms such as liquids, lotions, gels, creams, ointments, powders is carried out strictly according to customer specifications with a manufacturing license according to § 13 AMG. A wide range of different packaging machines is available for packaging, which meet the highest quality requirements in compliance with GMP.

The aim of this project was to integrate the existing qualification documents into a cross company qualification master plan and to qualify process plants of the entire production area (bulk production and packaging) in a retrospective project in conformity with GMP.

Your advantage: Our competence

Conceptual design/consulting in the area of qualification/validation
Conceptual design of all qualification measures
Structuring of the qualification activities via the qualification master plan
Time planning and resource management
Risk-based qualification management
Preparation and moderation of system specific risk analyses
Preparation of all qualification documents (IQ/OQ/FRQ)
Execution and documentation of all qualification tests (IQ/OQ)
Calibration/calibration management
Consulting in the field of maintenance and repair conception

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

GxP-compliant validation according to the V-model

Validation

Ensures process stability and robustness

Service portfolio of Testo Industrial Services GmbH

Service portfolio

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