Service 01 · Cleanroom testing
Cleanroom and contamination-control testing
Field testing and clear reporting that help you establish, maintain, and demonstrate control of your classified spaces — at initial qualification, routine requalification, and the moments in between.
What this covers
HEPA filter integrity testing
Aerosol challenge and scan testing of installed HEPA filters, with any leak locations documented for follow-up.
Airflow pattern visualization
Smoke studies to show flow direction and behavior at critical points, recorded on video with a location log for your files.
Particle counting & classification support
Non-viable particle counts to support room classification and periodic requalification, planned with reference to ISO 14644-1.
Room performance checks
Airflow velocity and volume, air-change calculations, pressure differentials, and recovery testing, as your program requires.
Environmental monitoring program support
Help designing or reviewing sampling locations, frequencies, and alert/action logic.
Contamination-control alignment
Connecting test results to your contamination-control strategy so findings lead to decisions, not just reports.
When teams call us
- A new or renovated suite is nearing qualification
- Periodic requalification is coming due
- Filters were changed or HVAC was modified
- EM results show an excursion or a trend worth a closer look
- An internal or client audit is coming and you want a fresh set of eyes
What you receive
- A test plan referencing your requirements and acceptance criteria
- Raw data with instrument identification and calibration records
- A summary report comparing results to your acceptance criteria
- Smoke-study video with a location log
- Observations and suggested follow-up, prioritized
How an engagement runs
- Scope
A short conversation about your facility, systems, timeline, and what your quality team needs to see.
- Plan
A written scope, method, and deliverables list, aligned with your SOPs and templates where they exist.
- Execute
On-site work with deviations raised as they happen — not after.
- Document & hand over
Reports and records formatted for your QA review and approval.
Standards we reference
References describe the methods we plan against; they don't imply endorsement or certification by any standards body.
Quantex Bioservices provides technical services and documentation support. Acceptance decisions remain with your quality unit. Information on this site is general and is not regulatory or legal advice.
FAQ
Whose acceptance criteria do you test against?
Yours. We can suggest criteria based on the relevant standards; your quality team approves them.
Can you set up a recurring schedule?
Yes. We can support recurring testing at the frequency your SOPs define.
What happens if a filter fails?
We document the location and result, discuss options with you, and retest after repair.
Often paired with
Planning a new suite, an expansion, or a recurring test program?
Tell us what you're working on. We'll reply with a few questions, a suggested scope, and next steps.
Request a testing conversationOr email [email protected]