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 for the pharmaceutical industry and medical technology 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. Find out more about our services.
Energy optimization in cleanrooms
The operation of cleanrooms and clean areas has a high energy requirement due to the need for air conditioning. There may be potential for optimization in terms of energy consumption.
We are happy to support you with the GMP-compliant qualification of technical optimization solutions such as the introduction of a setback mode or the reduction of the air exchange rate. In doing so, we determine possible effects on performance parameters of the cleanrooms as well as monitoring strategies in accordance with Annex 1, contamination control strategy (CCS), the EU GMP guidelines and DIN EN ISO 14644-2.
Manufacturing rooms represent the production environment and therefore have a decisive influence on product quality. Air purity and filter performance must be checked regularly. The results of measuring airborne particles in the cleanroom in the ‘at rest’ and ‘in operation’ states prove whether the particle count complies with the specifications for the defined cleanroom class. The filter leak test is a technically 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 purity class
- Recovery time measurements/recovery tests
- Filter leak test on HEPA filter
Maintaining defined, cascaded overpressure rooms generates an air flow from areas with higher cleanliness to areas with lower cleanliness. By supplementing pressure measurement with air flow and flow direction measurement, operational safety can be increased. We support you with qualification measurements in your cleanrooms:
- Determination of the supply air volume flow rate
- Calculation of the air exchange rate
- Flow visualisation
- Determination of the flow velocity of TAV flows
The protection of cleanroom areas from contamination from less clean areas is ensured by a differential pressure concept with regulated overpressure. By measuring the pressure and air flow, operational safety can be increased and product quality ensured. We support you with qualification measurements in your cleanrooms:
- Proof of differential pressure cascades
- Differential pressure measurement on the filter
In addition to particulate classification measurements, we also carry out microbiological sampling. We take care of the entire monitoring process, from planning to the final report. The limit values for this are specified in Annex 1 of the EU GMP guidelines. Our services in the field of microbiological monitoring:
- Classification measurement (microbiological)
- Air testing (active air sampling or sedimentation)
- Surface testing (direct sampling/contact test)
- Personnel testing (in sterile areas)
- Determination of sampling points, frequencies and action limits
- Sampling
- Analysis in a GMP-certified laboratory
- Total bacterial count determination
- Identification of bacteria (to genus or species)
- Consulting for OOS and OOT results
Like other components in the pharmaceutical industry that usually come into direct contact with the product, compressed gases must also meet certain quality standards. According to the compressed gas standard ISO 8573-1, particulate purity, residual moisture, oil content and microbiological purity must be tested.
- Measurement of particulate purity according to ISO 8573-1 Class 0 - 5
- Moisture/dew point measurement according to ISO 8573-1 Class 0 - 6
- Measurement of oil vapour in accordance with ISO 8573-1 Class 0 - X
- Measurement of oil aerosol with oil impactors Class 2 - X
- Microbiological sampling
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.
Medical Technology Services
Safety and compliance in medical technology
We also implement your quality assurance measures in the areas of calibration, qualification, validation and compliance in a pragmatic, cost-sensitive and effective manner in the medical technology environment.
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.
Your contact person
If you have any further questions, please do not hesitate to contact our expert at any time without obligation:
Seminars
Our GMP-specific seminars provide you with in-depth practical knowledge on the topics of qualification and validation.
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.
EVER Pharma Jena GmbH
Qualification of clean rooms in sterile production
Paul Hartmann AG
New cleanroom construction: project support & qualification
Pharma Stulln GmbH
Cleanroom qualification in aseptic production
At a well-known vaccine manufacturer
Qualification of pharmaceutical production facilities and cleanrooms