Specify a cleanroom robot by the process it must preserve. A useful requirement describes the product, contamination limits, robot configuration and operating conditions, then asks for evidence that matches them. The robot's cleanliness claim is one input to qualifying the installed handling cell.
This guide is for process engineers and equipment buyers handling sensitive substrates, components or materials. It provides a way to read supplier evidence and prepare an acceptance brief. The site's contamination-control and qualification specialists must choose the applicable methods and limits.
Define what “clean” means for this task
ISO 14644-1:2015 classifies air cleanliness by airborne particle concentration at specified particle sizes. Its scope does not characterize whether those particles are viable, chemically harmful or otherwise consequential to a particular product. Record the required class, sizes, measurement locations and operating state in the project requirement.
ISO 14644-14:2026, published in February 2026, addresses equipment suitability with respect to airborne particle cleanliness. It replaces the 2016 edition. Cleanability, biocontamination, decontamination-agent suitability and material properties such as electrostatic behavior sit outside that scope and need their own evidence where relevant.
Separate the questions in your brief. A semiconductor handling process may need both airborne-particle and electrostatic controls. A moisture-sensitive process also needs defined humidity conditions. An aseptic process requires controls appropriate to microbiological risk. Giving each requirement its own owner and acceptance evidence prevents one certificate from being asked to prove everything.
For room design or a modified installation, ISO 14644-4:2022 covers the requirements-to-design, construction and start-up process. Use the room and equipment scopes together when a new robot changes airflow, access or the way product is exposed.
Read the test conditions before the class
A qualification is most useful when you can identify the tested article and compare it with the proposed installation. Locate the model, variant, serial number or defined family; test method and edition; motion and payload; environment; sampling arrangement; date; validity; and restrictions.
Read a historical certificate as evidence
A Fraunhofer IPA qualification hosted by KUKA names the KR 6/10 AGILUS sixx CR series and the tested robot serial numbers. First issued November 5, 2014, it reports Class 2 suitability at 40% and 80% speed utilization, with 6 kg attached payload, axes operated separately and a one-second pause between cycles. The test environment was ISO 1 with vertical airflow.
The document restricts applicability to the named, unchanged product and states five-year validity. Treat this as a historical reading exercise, not current procurement certification. Request the current statement and underlying report for the exact supplied configuration.
The practical question is how closely your task matches the evidence. Simultaneous motion, a new tool, a different load or an altered environment deserves review. A mismatch becomes an open qualification item with an owner; it should not disappear into a general statement that the robot is “cleanroom rated.”
A newer example also needs its model boundary. KUKA's June 17, 2025 KMR iisy CR announcement describes 11 kg and 15 kg mobile-manipulator variants and claims ISO Class 3 and ESD certification. That is a manufacturer statement about those variants. A purchase should obtain the applicable certificates and compare the combined platform, arm and load with the intended use.
Review everything that moves, touches or sheds
| Area | Question to resolve | Evidence to request |
|---|---|---|
| Robot and motion | Does qualification cover this variant and duty? | Current report, tested configuration, trajectory and load |
| Tool and product contact | What can transfer to the substrate? | Material, wear, contact and cleaning compatibility records |
| Cables and services | Where do flexing, rubbing or exhaust occur? | Routing design and representative operating assessment |
| Airflow and layout | How does the installed cell affect product exposure? | Site layout, airflow assessment and qualification plan |
| Cleaning and maintenance | Can approved methods reach required surfaces? | Supplier-approved agents, procedure, access and re-entry plan |
| Additional controls | Are moisture, ESD or biological limits relevant? | Separate requirements, methods and acceptance records |
Walk the material path from incoming carrier to outgoing carrier. Identify when a sensitive surface becomes exposed, what passes above it, what touches it and where it waits. Include loading, rejected-product handling, replenishment and maintenance access. A clean handling motion can be undermined by an uncontrolled surrounding step.
For a glass substrate, for example, the gripper's contact surfaces and service lines deserve inspection alongside the arm. Identify the required orientation and supported area, then check that the tool avoids unacceptable contact and deformation under the real acceleration and load. Use the six-axis selection guide to organize geometry and load questions; cleanliness and mechanical suitability need to be satisfied together.
Turn the comparison into an acceptance plan
- Freeze a configuration. Record robot, tool, software, cables, consumables, load, trajectory, cycle and room conditions. Preserve revision identifiers so the assessment can be repeated.
- Agree on measurement. Have the qualification lead specify locations, particle sizes, operating states, instruments, sampling and acceptance limits using the applicable methods. Record background conditions alongside equipment operation.
- Exercise representative conditions. Include normal production and the agreed demanding conditions. Record unusual observations and interventions with their times.
- Trace exceptions. Relate an excursion to the configuration and operating event. Investigate before changing hardware or declaring a repeat result representative.
- Close the evidence gap. Document the accepted scope, failed or untested items, responsible person and required next action.
Illustrative project change
A team approves a demonstration with an empty end effector, then proposes a vacuum gripper and new moving hose for production. The useful response is to update the configuration record, inspect the new contact and flexing surfaces, and ask the qualification lead which assessments must be repeated. The earlier result remains evidence for the earlier configuration.
Keep particle measurements, product-defect observations and process output as separate evidence streams. Similar timing can suggest a hypothesis, but identifying a cause requires a controlled investigation. A supplier's certificate and a site's product-yield study answer different questions.
Keep the evidence attached to the installed process
Handover should include current reports, approved cleaning methods, maintenance instructions, spare-part specifications and the configuration baseline. Assign review triggers for changes to speed, tool, load, cable routing, seals, lubricants, cleaning agent, airflow or layout. Record what was reviewed and why the existing evidence remains applicable, or what further work is required.
Download the editable cleanroom robot evidence brief. It separates airborne cleanliness from other requirements and includes the historical-certificate exercise. For project ownership, trial cost and production acceptance, continue with planning a manufacturing robot project.