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ON CALL 24/7 · (408) 426-6140WINDSOR, CA · CA LIC #825594
SERVICE 02 · ISO 14644-1 · IEST-RP-CC006.4

Testing & Certification,
by an independent third party.

Independent certification of cleanrooms, laminar flow hoods, mini-environments, and bio-safety cabinets, under credentialed supervision. Every result lands in a bound, documented report with approval stickers, ready to hand to an auditor as-is.

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Independent third partyCredentialed supervisionBound, audit-ready reports
CERTIFICATION · ROOM PARTICLE COUNTS

The standard battery run on every certification.

01-05
01

Airflow velocity & uniformity

Confirms air changes and laminarity match design, the first parameter to drift as filters load.

02

HEPA filter installation leak

Scan-tests every filter face, frame, and seal for bypass leakage.

03

Room particle counts

Multi-point counts against your class limits, as-built, at-rest, or operational.

04

Enclosure pressurization

Verifies the pressure cascade that keeps unclassified air out.

05

Temperature & humidity

Confirms environmental controls hold spec through a working cycle.

Optional tests

ON REQUEST
01Visual airflow characterization (smoke pattern studies)
02HEPA filter bench tests prior to installation
03Light level
04Noise level

We watch more than the instruments.
Every certification includes a free ancillary audit.

Credentialed supervision

A credentialed supervisor verifies quality on every certification.

Discipline observed

We watch personnel protocol, housekeeping, and total room integrity while we test.

Written recommendations

Protocol and housekeeping observations, written up with fixes before the crew departs.

Baselines that pay off

Typically annual under ISO 14644-1:2015 clause 5.1, every six months under USP 797 or EU GMP Annex 1, tighter where your quality system calls for it. A benchmark that raises yields.

Certification questions

The state your compliance requirement names. cGMP and USP work usually certifies operational; new construction proves as-built first, then at-rest. We test all three and note the state on every report.

Most single rooms test in a day, and the bound report follows within days, not weeks. Multi-room facilities get a schedule up front.

Every test result against its standard, instrument calibration records, pass/fail per point, and approval stickers for the room, bound and formatted to hand straight to an auditor.

ISO 14644-1 classifies the air; cGMP governs pharma manufacturing practice; USP 797/800 applies to compounding pharmacies. Many rooms answer to two at once. We'll map your requirement before we quote.

Related reading

Browse all articles
TESTING & CERTIFICATIONHow often should a cleanroom be certified?Typically annual under ISO 14644-1:2015, six months under USP 797 and EU GMP Annex 1, and any time the room changes.Read
STANDARDSISO 14644-1 class limits, explainedWhat an ISO class actually designates, why the table has blank cells, and what a complete classification has to state.Read
TESTING & CERTIFICATIONWhy cleanrooms fail certificationThe tests a room fails most often, what usually causes each one, and what happens after a failed result.Read

Tell us about your environment.

Walk us through what you run and the standard the room has to hold. We'll come back with the right plan for the job, usually within one business day.

Request a quoteCall (408) 426-6140