Product Quality and Compliance

Cleanroom Qualification

Your cleanroom must be able to permanently demonstrate the required performance – to customers, auditors and authorities. Contamination, deviations or gaps in documentation not only jeopardize product quality, but also approvals and compliance.

Our service technicians perform cleanroom qualifications in accordance with EN ISO 14644 and GMP guidelines—for both SCHILLING cleanrooms and third-party facilities. Whether it’s an initial qualification or a requalification, you’ll receive reliable measurement results and comprehensive test reports.

Our service for you

Particle measurements in the cleanroom

As part of the qualification process, we carry out particle measurements in the cleanroom to determine the number and size of particles per cubic meter:

Determination of the cleanroom class
Recovery time measurement / recovery test
Integrity test / filter leak test
Clean-up measurement

Flow measurements

Measurements and visualizations of air flows for cleanroom qualification:

Measurement of the air velocity
Measurement of the air volume flow
Calculation of the air exchange rate
Proof of the uniformity of the speed
Flow visualizations

Climate measurements

For some applications, temperature and room humidity must be controlled. We carry out the room measurements for you:

Individual temperature measurements
Individual measurements of relative room humidity

Pressure measurements

We demonstrate compliance with the specified pressure and pressure cascades for the qualification of cleanrooms:

Verification of the differential pressure cascades
Differential pressure measurement on the filters

Other measurements

We are also there for you for further measurements and tests in your cleanroom:

Sound pressure level measurement
Illuminance measurement
Air germ measurement
Area germ measurement
Measurement of soil drainage capacity
Component testing

Qualification and requalification

Qualification

Cleanroom qualification ensures that your cleanroom meets the standard-specific requirements. Our trained service technicians carry out the qualification tests in accordance with DIN EN ISO 14644 or the EU GMP guidelines. The measurements are recorded in a detailed qualification protocol and, if required, in GMP documentation. All work steps, test procedures and measured values are thus traceable for external test bodies.

Request qualification

Requalification

Requalification is carried out to prove that the cleanroom system is still in a qualified condition after modifications. Requalifications are also prescribed at periodic intervals as part of revalidation. The particle measurements for room qualification must be repeated every 6 or 12 months, depending on the zone.

Request requalification

Our service - your benefits

In accordance with EU GMP guidelines and DIN EU ISO 14644
GMP documentation
Transparent billing per measuring point
Expertise from experienced service technicians
Proportionate travel costs due to bundled assignments

We were very satisfied with the advice and support provided during the sales process and project management.

Dr.-Ing.Paul Cvancara, Academic advisor / group leader

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Albert-Ludwigs-University Freiburg

We were very satisfied with the handling of the project and the overall package was perfect.

Markus Jäggi, Head of Technology

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avintos AG

"We are very satisfied with the advice and the quality of the cleanroom. It was also great that the schedule was adhered to."

Dr. Stephan Mingels, Teamleader R&D

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Buehler

From "A" to "Z" it went through cleanly. It was a pleasure!

Markus Zbinden, Head of GF & XRS specialist group

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Comet AG

All questions were answered to our complete satisfaction and our individual needs were also taken into account. We are very impressed by the robustness of the tent and the professional workmanship.

Dr. Adrian Rodríguez Rodríguez, GSI Detector Laboratory

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GSI Helmholtz Center

Schilling Engineering gave us very good advice and adapted the system to our circumstances. The price was also right.

Marcus Hutter, Head of Facility Management

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Hagleitner Hygiene International GmbH

We have been working with Schilling Engineering for years because they have the know-how. Here we have one point of contact and one company that delivers everything.

Marcel Lechmann, Head of Special Projects

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Hamilton Bonaduz AG

The advice was really good. The additional questions were answered comprehensively and satisfactorily.

Antje Drechsler, Technician

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Karlsruhe Institute of Technology (KIT)

We're completely satisfied with everything. If you need anything for a cleanroom, Schilling is the right place to go.

Marcel Fetzer, Technical Manager / Member of the Executive Board

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Kunststoff-Packungen AG

If you have any questions, you can always contact Schilling and a solution will be found. Praise also goes to the service technicians, they are great!

Stefan Burtscher , Business Development

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Lercher Medical GmbH

Service and support run smoothly, which was an important reason to buy from Schilling again. The price-performance ratio is right.

Joseph Spahr, Pre-clinical Drug Product Manufacturing

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Lonza Ltd.

The overall package was right - the price, the advice and the entire process.

Thorsten Deja, Production Planner / Leader Cleanroom & Assemblies

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Mitsubishi Chemical Advanced Materials

The entire sales process and advice through to final assembly was very good. Everything went smoothly. We would like to realize further projects with Schilling Engineering.

Nicolas Wirth, Head of Process Unit Fulfillment

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Permapack AG

From our initial contact through to the completion of the project, our interactions were always conducted on an equal footing. We quickly realized that SCHILLING ENGINEERING was exactly the right partner for us. We could tell this from the open and honest communication right from the start.

Gregor Kaminski, Production Manager

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Schwarzer Precision GmbH

Schilling Engineering has a good name and a good overall package.

Dr. Achim Müller, Project manager

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Sigmund Lindner GmbH

We decided to buy from SCHILLING ENGINEERING because we knew exactly what level of quality and service to expect. On a scale of 1 to 10, I give them a 10!

Lukas Samaras, Optical Engineer

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Spacetech GmbH

Schilling has a good reputation in the industry and is known for its extensive experience and high quality. Our customers were very pleased when they found out who we were working with to build the cleanroom.

Claudia Dubois,

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Switzerland Innovation Park Biel/Bienne

The decisive factor for the purchase of the tents was the very good advice provided by SCHILLING ENGINEERING on site. The entire system is extremely flexible and was specially adapted to our needs. It was a planning and investment in the future.

Christian Bach, Process technology

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Winterhalder Selbstklebetechnik GmbH

We are very satisfied with the work done by SCHILLING ENGINEERING. Consulting, planning, delivery time, and installation—everything went very smoothly.

Dr. rer. nat. Martin Nittmann , Managing Director

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Xiton Photonics GmbH

Visualization of the air flow

We are happy to offer flow visualizations for your cleanroom.

Mist generators and video recordings are used to visualize and test the air flows within the cleanroom.

FAQ

Qualification

What is a cleanroom qualification?

Cleanroom qualification is a procedure for checking and documenting compliance with defined parameters. The parameters are designed based on the required quality for the product or personal protection and comfort. Standards such as ISO 14644 or VDI 2083 or GMP Annex 1 can be used as a basis for defining e.g. particle limit values, air exchange rates, recovery times etc.

Why is cleanroom qualification necessary?

The aim of a cleanroom qualification is to ensure that the cleanroom is suitable for the intended purpose and guarantees the desired quality of the products or processes. The qualification is documented proof that the cleanroom system is planned, built, installed and operated in accordance with user requirements and the applicable regulations.

Why and how often must a requalification be carried out?

The requalification of a cleanroom is carried out to check its performance and compliance with the specified standards for the cleanroom class. Requalification must be carried out at regular intervals to ensure that the cleanroom fulfills its function and does not cause contamination. The frequency of requalification depends on various factors, such as the type of activities in the cleanroom, the requirements of customers or authorities, the results of routine monitoring and changes to the facility or equipment. We recommend carrying out a requalification at least once a year. Our overview shows the recommended intervals.

What standards are used for cleanroom qualification?

In ISO, it is usually sufficient to carry out and record a qualification in accordance with ISO 14644-3. The resulting qualification protocol then serves as documented proof.
In the GMP area, the requirements are more stringent and the result of each test should be documented according to a predetermined procedure and released for the next step:
DQ: Design Qualification = design qualification
IQ: Installation Qualification = installation qualification
OQ: Operational Qualification = functional qualification
PQ: Performance Qualification = performance qualification

How does particle measurement in the cleanroom ensure the required cleanroom classification?

The classification of a cleanroom into a specific class is based on precise particle measurement in the cleanroom, which records the concentration of particles in the air. These measurements are typically carried out using a laser particle counter to ensure that the number of particles present in the air does not exceed the limits set for the relevant ISO or GMP classification. By strictly controlling and minimizing these particles, a cleanroom will meet its classification, which is essential for maintaining the required cleanliness standards in sensitive production and research environments.

Product Quality and Compliance

Cleanroom Qualification