HEPA filter integrity testing
DEHS aerosol upstream and photometer scan of the filter media, gasket and frame.
Why it matters: Proves there are no leaks that can let particles into the room.
For pharma, biotech and life sciences sites
Cleanroom Validation Services for Grade A to D Cleanrooms
IncepBio provides cleanroom validation services, from cleanroom qualification of new facilities to periodic requalification, HEPA filter integrity testing and HVAC validation, with protocols and reports ready for your QA and auditors.
- Cleanroom qualification and requalification services
- HEPA filter integrity testing, ISO 14644 classification, airflow and pressure
- HVAC validation and static and dynamic smoke studies
- Testing aligned with ISO 14644, EU GMP Annex 1, WHO GMP and Revised Schedule M
Grade A to DISO 5 to ISO 8 cleanrooms
Protocol to reportAudit-ready documentation
Inspection supportAudits and observation closure
India, Malaysia, SingaporeOn-site execution
Cleanroom testing services we perform
What each test checks, and why it matters for GMP compliance and audits.
Airflow and HVAC verification
Air velocity and air volume measured at each terminal filter and LAF/UDAF unit.
Why it matters: Confirms the design airflow is reaching the room.
Air change rate
Calculated from measured air volume and room size.
Why it matters: Shows the room is diluting contamination at the required rate.
Particle count and ISO 14644 classification
Non-viable particle count at rest and in operation.
Why it matters: Proves the room meets its ISO class and GMP grade.
Differential pressure mapping and balancing
Pressure cascade mapping between rooms, pressure balancing, containment and segregation checks.
Why it matters: Confirms air flows from clean to less clean areas.
Recovery test
Time taken to return to the required class after a particle challenge.
Why it matters: Shows how quickly the room recovers after a disturbance.
Smoke study (airflow visualization)
Static and dynamic, for aseptic lines, UDAF, RABS and isolators, with multi-angle video.
Why it matters: Gives auditors visual proof of unidirectional airflow over critical zones.
HVAC validation
AHU hydro testing, duct leakage testing, air balancing and HVAC troubleshooting.
Why it matters: Confirms the system that supplies the air performs as designed.
Temperature and humidity monitoring
Room temperature and relative humidity recorded during qualification.
Why it matters: Confirms the room holds the conditions your product and process need.
Test equipment we use: particle counters, aerosol photometers, DEHS aerosol generators.
Not sure which tests your rooms need?
Share your room list and grades. We will map the tests and send a scope.
Cleanroom audit findings we help you close
Cleanroom findings that can come up during inspections and internal audits, and how our testing helps close them.
Finding
HEPA leak test not repeated after a filter was replaced
How we close it
Post-change HEPA filter integrity testing, with the filter ID and results recorded.
Finding
Auditor asked for proof of airflow in operation
How we close it
Dynamic smoke study with operators and equipment in action, recorded on video.
Finding
Room passes at rest but fails in operation
How we close it
Particle count in both states, airflow and air change checks, and a smoke study to find the cause.
Finding
Recovery time never established for the room
How we close it
Recovery test with method and acceptance criteria written into the protocol.
Finding
Pressure cascade not verified between adjacent rooms
How we close it
Differential pressure qualification across the full cascade.
Finding
Raw data cannot be traced to the final report
How we close it
Raw data sheets and summary reports that link each result to its test.
Have an open cleanroom observation?
Tell us the finding. We will confirm the tests and documents needed for closure.
About our cleanroom validation services
IncepBio is a cleanroom validation company based in Bengaluru, India. We test and document that your cleanrooms and HVAC systems meet the required ISO 14644 class and GMP grade.
Our scope covers new facility qualification, periodic cleanroom requalification, testing after changes, and regulatory inspection and audit observation support, for pharma, biotech and life sciences sites in India, Malaysia and Singapore.
ISO 14644EU GMP Annex 1WHO GMPUS FDA cGMPRevised Schedule M
Cleanroom grades we qualify
| Grade | At rest | In operation |
|---|---|---|
| Grade A | ISO 5 | ISO 5 |
| Grade B | ISO 5 | ISO 7 |
| Grade C | ISO 7 | ISO 8 |
| Grade D | ISO 8 | Set by site risk assessment |
As per EU GMP Annex 1 and ISO 14644-1.
Request cleanroom validation services
Tell us about your cleanroom. A validation engineer reviews every request and prepares the scope.
- You share your requirementTwo quick choices and your contact details.
- We review and call youA validation engineer confirms rooms, grades and tests.
- You receive a scope and proposalTests, deliverables and schedule for your site.
Prefer to talk now?
+91 63669 42391How a cleanroom validation project runs
A clear sequence from your first request to QA sign-off.
Scope and proposal
Rooms, grades and tests agreed.
Protocols
Prepared for your QA approval.
On-site testing
As per the approved protocol.
Data review
Results against acceptance criteria.
Reports
Summary reports with raw data.
QA sign-off
Review and closure.
What you receive
Approved validation protocols
Raw data sheets
Compliance documents
Deviation assessment
Summary reports
Smoke study videos
Why choose IncepBio as your cleanroom validation company
Related services: CQV services, smoke studies and BMS and EMS validation.
Validation is our core work
Cleanroom, HVAC, CQV and CSV validation for pharma and life sciences.
Audit-ready documentation
Protocols, raw data and reports your QA can approve.
One team, full scope
Cleanroom qualification, HVAC validation and smoke studies together.
India, Malaysia, Singapore
On-site execution with our own validation team.
Cleanroom validation FAQs
Scope, testing and documentation for cleanroom qualification and requalification.
Get a QuoteCan you requalify our cleanrooms without stopping production?
Yes. We plan the testing schedule with your team around your production plan.
Our HEPA filter failed the leak test. What happens next?
The leak is recorded in the report. Once the filter is repaired or replaced, we retest it and issue the updated result.
We replaced one filter. Do we need full requalification?
Not always. We assess the impact of the change and test the affected filter and room parameters. Your QA decides the final scope based on this impact assessment.
Our room passes at rest but fails in operation. Can you find the cause?
Yes. We check airflow, air changes, pressure and particle count, and use HVAC troubleshooting and smoke studies to help identify the cause.
The auditor wants dynamic smoke study videos. Can you do this?
Yes. We perform dynamic smoke studies for aseptic lines, UDAF, RABS and isolators, with multi-angle video recording and a written report.
Can you take over from our previous validation vendor?
Yes. We review your existing protocols and reports and continue requalification with protocols approved by your QA.
Who prepares the protocols?
We prepare the validation protocols and share them with your QA for approval before testing.
Which test equipment do you use?
Our team uses particle counters, aerosol photometers and DEHS aerosol generators for cleanroom testing, with results recorded in raw data sheets and summary reports.
What do you need from us to provide the service?
Your room list, cleanroom grades, area layout, HVAC details and the last validation report if available. Room details are optional when you first contact us.
Do you provide cleanroom certification services?
We perform ISO 14644 classification and performance tests and issue test reports that your QA uses to certify and release the cleanroom.
Do you provide cleanroom validation services in Malaysia and Singapore?
Yes. IncepBio provides cleanroom validation services across India, including Bengaluru and Hyderabad, and in Malaysia and Singapore.
Request cleanroom validation services
Share your rooms and grades. Our validation team replies with a scope and proposal.