Stem Cell Clean Room Recertification Process: Completed in Three Days

08:56 - 10/09/2025 120

Learn about the GMP-standard stem cell cleanroom re-evaluation process in 3 days

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☰ Article Table of Contents

1. Stem cell cleanroom requalification process: Completed in three days
1.1. Significance of cleanroom requalification
1.2. Why requalify twice a year?
1.3. Main steps in the requalification process
1.4. Implementation time: 2–3 days for 30 m²
1.5. Supporting equipment: CliniMACS Prodigy
2. Summary of shared knowledge
3. Conclusion

Stem cell cleanroom requalification process: Completed in three days

Significance of cleanroom requalification

At the University Hospital of Tübingen (Germany), the Joint Stem Cell and Immunology Laboratory had CAT Clean Air Technology (CAT Group) perform requalification of a 30 m² clean area. This is where stem cell products are manufactured for immunotherapy, while also providing samples for patients worldwide through cryopreservation processes. Due to the particularly sensitive nature of the products, ensuring the cleanroom always maintains environmental control standards is a key factor to protect quality and safety for patients.

Why requalify twice a year?

Cleanrooms meeting GMP (Good Manufacturing Practice) standards are required to undergo periodic requalification twice a year. This activity helps verify that the cleanroom still complies with proper design, accurate installation, correct operational procedures, and maintains performance according to current legal regulations. This is a mandatory requirement to ensure stability and reliability in the production of biological products.

Stem cell cleanroom requalification process

Main steps in the requalification process

A cleanroom requalification cycle typically includes four important phases:

Design Qualification (DQ) – Design qualification: Evaluate drawings and design standards.
Installation Qualification (IQ) – Installation qualification: Check construction and equipment installation according to proper design.
Operational Qualification (OQ) – Operational qualification: Assess operational capability in two states: at rest and in operation.
Performance Qualification (PQ) – Performance qualification: Ensure the system maintains stable environmental quality during actual use.

Implementation time: 2–3 days for 30 m²

Despite only having a 30 m² area, the requalification process still requires 2–3 days to complete. The reason is that many items must be measured in detail, including: checking filter tightness and leakage, measuring air flow, differential pressure, air recovery time, evaluating cleanliness levels as well as microbiological analysis. These are all mandatory indicators in highly sensitive environments such as stem cell production.

Stem cell cleanroom requalification process

Supporting equipment: CliniMACS Prodigy

The laboratory also uses the CliniMACS Prodigy semi-automated system – a device that integrates the entire cell processing workflow: from separation, washing, expansion, activation, to product stabilization. The advantage of this device is its high automation, minimizing manual error risks, ensuring consistent quality and GMP compliance in cell and gene therapy manufacturing.

Summary of shared knowledge

Content	Highlights
Requalification frequency	2 times per year according to GMP standards
4-step process (DQ–IQ–OQ–PQ)	Ensure design – installation – operation – performance
Implementation time	2–3 days for 30 m² area
CliniMACS Prodigy application	Automate cell production, ensure stable quality

Conclusion

Cleanroom requalification is not only a mandatory requirement in pharmaceutical and stem cell production, but also the foundation for ensuring safety, quality and consistency of products. With systematic processes and modern equipment, the cleanroom at the University Hospital of Tübingen is clear evidence of the important role of environmental control in modern medicine.