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Cleanroom qualification

Testo Industrial Services offers you professional support for all GMP measures in the area of cleanroom qualification. We carry out all qualification tests in accordance with Annex 1 of the EU GMP Guide, DIN EN ISO 14644 and VDI 2083

In addition to cleanroom qualification, our cleanroom solutions also include testing and qualification of safety cabinets, isolators and other clean air systems. 

We accompany you from the conception and planning of the qualification phases (DQ, IQ, OQ, PQ), through the implementation of risk management in accordance with the requirements of ICH Q9/ EU GMP guidelines, to the maintenance services and requalification measures of your cleanrooms. We support you with individual measurements or take over the complete project management

Our service for you:

Validation of the Saveris monitoring system for monitoring temperature and humidity values

Climate measurements 

Reproducible climatic conditions are indispensable for the production of sensitive products in cleanrooms. We support you in ensuring constant temperature and humidity values in your clean room: 

  • Individual measurements of temperature and relative room humidity 
  • Carrying out climate mappings in cleanroom areas 
  • Definition of critical monitoring points 
  • Commissioning, validation and calibration of monitoring systems 
Performing a differential pressure measurement on a HEPA filter in a clean room   Tip: Image t

Pressure measurements 

The protection of cleanroom areas from contamination from less clean areas is ensured by a differential pressure concept with controlled overpressure. By measuring the pressure and the air flow, operational safety can be increased and the quality of the products ensured. 
We support you with qualification measurements in your cleanrooms: 

  • Proof of the differential pressure cascades 
  • Differential pressure measurement on the filter 
Determination of the flow velocity of a TA flow with the aid of a vane wheel

Flow measurements

Maintaining defined, cascaded positive pressure chambers generates air flow from areas of higher purity to areas of lower purity. By supplementing pressure measurement with measurement of air flow and flow direction, operational reliability can be increased. 
We support you with qualification measurements in your cleanrooms: 

  • Determination of the supply air volume flow 
  • Calculation of the air exchange rate 
  • Flow visualisation 
  • Determination of the flow velocity of TAV flows 
Durchführung einer mikrobiologischen Probenahme im Rahmen einer Reinraumqualifizierung

Microbiological monitoring

In addition to particle classification measurements, we also carry out microbiological sampling. We take over the complete handling of the monitoring measures from planning to the final report. The limit values for this are defined in the EU GMP guidelines Annex 1. Our services in the field of microbiological monitoring: 

  • Classification measurement (microbiological) 
  • Testing of air (active air sampling or sedimentation) 
  • Testing of surfaces (direct sampling/swab test) 
  • Testing of personnel (in sterile areas) 
  • Determination of sampling points, frequencies and action limits 
  • Sampling 
  • Analysis in a GMP-certified laboratory 
  • Total germ count determination 
  • Identification of germs (to genus or species) 
  • Advice on OOS and OOT results 

Your advantage: Our expertise

  • Expertise: Consulting, measurements, project management - our industry-experienced team supports you precisely & in line with your needs
  • Technology: The use of our measuring equipment with more than 4,500 references ensures reliable measurement and test results
  • Documentation: We hand over the documentation in the audit-proven layout or individually according to customer requirements to you personally on completion of the order.

GMP Training Centre

Our fully equipped and GMP-compliant clean room incl. personnel airlock offers optimal conditions for the training of our clean room staff on an area of 90 m2. It is also used for the practical implementation of seminar content. 

Facts about the cleanroom training centre: 

  • Adjustable to ISO classes 5-8 (GMP: B-D) 
  • Differential pressure cascade and zone concept 
  • Practice filter for clean room measurements 
  • Incl. training equipment, e.g. safety workbench, autoclave and training facility for calibrations
Cleanroom training centreOpens video in overlay

GxP-Services Team

Professional competence, experience and high-precision equipment. The engineers and technicians of our GxP-Services Team are on duty for you throughout Europe.

Die Fachexperten des GxP-Services-Team sind deutschlandweit für Sie im Einsatz
Know-how Calibration, qualification, validation

Know-how

In our knowledge centre you will find answers from our experts to many questions about cleanroom qualification. 

Knowledge Centre Cleanroom

Success stories

We support you in your projects and are committed to your goals. Here you will find an excerpt from the references of our successful qualification projects in the cleanroom sector.

Cleanroom qualification in aseptic production

Pharma Stulln GmbH

Clean room qualification in aseptic production

Carrying out a cleanroom qualification in aseptic production

At a well-known vaccine manufacture

Qualification of pharmaceutical production facilities and clean rooms