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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.

pharmazeutische Verpackungsanlage bei der Pharma Stulln GmbH

Clean room qualification in aseptic production

Testo Industrial Services carried out the requalification of the aseptic production facilities as well as the calibration of the humidity, temperature and differential pressure sensors with measurement uncertainty assessment according to GUM for Pharma Stulln GmbH.

As an innovative pharmaceutical company, Pharma Stulln GmbH has been producing eye drops, nasal sprays and inhalation solutions aseptically for more than 30 years in its own product range and in contract manufacturing for well-known pharmaceutical companies. The production of pharmaceuticals is carried out in accordance with the AMG, AMWHV and EU GMP guidelines. Furthermore, the company manufactures medical products according to MPG and is certified for this purpose according to DIN EN ISO 13485.

The aim of this project was to ensure the cleanroom status of the aseptic production premises by means of requalification measurements and to demonstrate controlled environmental conditions for the production of perfect product quality. In addition to meeting the regulatory requirements, a pragmatic and cost-sensitive approach was implemented as well as the integration of customer-internal resources in the structuring and processing of the qualification measures.

Your advantage: Our competence

Calibration of humidity, temperature and differential pressure sensors with measurement uncertainty consideration according to GUM
Proof of compliance with cleanroom classes A/B/C and D
Filter leak test on terminal filters and LF units
Differential pressure measurement on terminal filters
Uniformity of the flow velocity
(TAV flow) on LF units
Air volume determination/air exchange rate

The result

In addition to meeting the regulatory requirements, a pragmatic and cost-sensitive approach was implemented as well as the integration of customer-internal resources in the structuring and processing of the qualification measures. The result was the holistic support of the customer in the area of clean room, calibration and qualification of the premises in the production.

Durchführung einer Differenzdruckmessung an einem HEPA-Filter

More about our services

Überprüfung eines HEPA-Filters auf Lecks

Clean room qualification

Security and compliance for your cleanrooms

Kalibrierung von elektrischen Messgeräten

Calibration

On-site calibration and laboratory calibration of your quality relevant test and measuring equipment

Kalibrierung eines Sensors in einem Tauchbecken

Service portfolio

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