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

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 visualization
Determination of the flow velocity of TAV flows

Prüfung der Luftreinheit in einem Reinraum

Air purity/filter performance test

Manufacturing rooms represent the production environment and thus have a decisive influence on product quality. Air purity and filter performance must be tested regularly. The results of measuring the airborne particles in the cleanroom in the "at rest" and "in operation" states prove whether the particle count meets the specifications for the defined cleanroom class. The filter leakage test is a metrologically complex part of cleanroom qualification and is carried out in accordance with DIN EN ISO 14644-3. We support you with these tests in your cleanrooms:

Determination of the particulate cleanliness class
Recovery time measurements/recovery tests
Filter leak test on the HEPA filter

Your advantage: Our competence

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 including 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

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.

GMP-compliant documentation in the context of plant qualification