Clean Room Qualification

Qualify a new or modified cleanroom before it goes live

When a cleanroom is newly built, relocated or modified, its performance against the intended design classification needs to be confirmed before — or immediately after — it goes into use. Vanavil Calibrations carries out clean room qualification testing for exactly that moment, with a documented report for your commissioning file.

Clean room qualification is the initial or post-modification confirmation that a cleanroom performs to the classification it was designed for — carried out when a facility is newly built, relocated, or changed in a way that could affect its controlled environment. Vanavil Calibrations provides clean room qualification services, sometimes referred to as clean room certification services, as a distinct engagement from routine testing or a recurring validation programme.

What Clean Room Qualification Is

Confirming design intent before a cleanroom is put to work

A newly commissioned cleanroom, or one that has just been modified — a changed layout, a relocated piece of equipment, a filter bank replacement — hasn't yet demonstrated that it performs to the classification it was designed for. Clean room qualification is the baseline testing exercise that closes that gap: it measures the space against its intended design classification before, or immediately after, it is put into operational use.

This is different from a routine test on an already-running room, and different from a scheduled validation programme that re-confirms performance over time. Qualification is tied to an event — a new facility, a modification, a relocation — not a calendar.

Technician carrying out baseline qualification testing in a newly commissioned cleanroom

A note on certification: Qualification confirms a cleanroom performs to its design classification. Vanavil Calibrations carries out qualification testing and issues detailed, documented test reports. Where a facility requires formal third-party certification against a specific regulatory or industry certification scheme, that certification must be obtained through the relevant accreditation body — please confirm your exact certification requirement with our team before assuming scope.

Why It's Required

Confirming performance before a space goes live matters

New Facility Risk

A newly built cleanroom hasn't yet proven it performs to its design classification under real operating conditions.

Post-Modification Drift

Layout changes, relocated equipment or filter replacement can shift airflow and pressure patterns even in an established room.

Commissioning Sign-Off

Facility commissioning and handover documentation typically expects baseline qualification evidence before operational use begins.

What We Qualify

Parameters covered in a qualification test

Airborne particle counts against the intended design classification
Airflow velocity and distribution across the space
HEPA filter installation and integrity
Differential air pressure between adjoining areas
Temperature and humidity
Light intensity and sound level, where relevant to the space

Typical Applications

When clean room qualification is called for

Industries Served

Healthcare

Operation theatres & critical care

Pharmaceutical

Manufacturing & sterile areas

Laboratories

Research & QC environments

Industrial

Precision manufacturing

Qualification Process

Design Review

We review the room's intended classification, layout and design documentation before testing begins.

Baseline Qualification Testing

Testing is carried out against ISO IEC 17025:2017 procedures to confirm the space performs to its design intent.

Documented Qualification Report

You receive a report confirming baseline performance, ready for your commissioning or handover file.

Requalification Advice

Where a future modification could affect performance, we advise on when the space should be requalified.

Why Choose Vanavil

One accredited provider from commissioning through to routine testing

NABL-accredited calibration and validation
ISO/IEC 17025:2017-compliant procedures
On-site testing and laboratory capability
One accountable team from qualification through to ongoing testing and validation
20+ years of experience, serving clients since 2004

Talk to Our Team

Technician monitoring readings during a cleanroom qualification test

Related Services

FAQ

Is clean room qualification the same as certification?

Not exactly. Qualification is the testing and documentation process that confirms a cleanroom performs to its design classification. Vanavil Calibrations carries out this qualification testing and issues detailed test reports. If your facility needs formal third-party certification against a specific regulatory or industry scheme, that certification is issued through the relevant accreditation body — talk to our team to confirm your exact requirement.

When does a cleanroom need qualification?

Typically when a facility is newly built and about to go into use, or after a modification — a layout change, equipment relocation, or filter replacement — that could affect how the space performs against its design classification.

How is qualification different from validation?

Qualification is tied to an event — a new facility or a modification — and confirms baseline performance against design intent. Validation is the recurring, scheduled programme that re-confirms performance over time. See our Cleanroom Validation page for the full process.

Commissioning a new cleanroom, or modifying an existing one?

Tell us about the space and what triggered the need for qualification — we'll scope the baseline testing and documentation.

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