Cleanroom Particle Count Testing in India

THE SERVICE

Particle count (NVPC) testing in Ahmedabad, with traceable instruments.

Non-viable particle count (NVPC) testing uses a calibrated optical particle counter to measure airborne particles in a cleanroom or clean zone. The results classify the area against ISO 14644-1 and the grade limits in EU GMP Annex 1 and Schedule M, confirming that the room is as clean as its intended use requires.

NVPC testing is commonly used to refer to Non-Viable Particulate Count testing. It monitors non-living particles in cleanrooms to ensure cleanliness. It uses particle counters to detect airborne particles in both static and dynamic circumstances. These particles can include dust, fibers, or other contaminants that may affect sterile processes, especially in pharmaceuticals , Medical & Lab Sectors , biotech , and electronics manufacturing .

Why Choose Kesar Testing Service LLP for NVPC Validation/Testing Services in Gujarat, India ?

Trained experienced professionals

Modern & Accurate Equipments

Fast turnaround and detailed documentation

Fully compliant with industry standards

Kesar Testing Service LLP uses high-precision instruments such as TSI AeroTrak A100, and MiniColt 4S to conduct Airborne Particle Count tests for Non-Viable Particle Count (NVPC) validation. These instruments allow for accurate monitoring of particulate contamination levels in regulated environments such as cleanrooms, assuring compliance with ISO and GMP requirements. Our qualified team provides both onsite and in-house validation services, ensuring that clients maintain air quality integrity and meet regulatory standards with confidence.

Feel free to contact us for reliable, expert calibration and validation services in Ahmedabad, Gujarat, India.

Our Validation Services

HEPA Filter Integrity Validation

Recovery test validation

Temperature and Humidity mapping

LUX and Noise Mapping

Compressed Air Validation

Equipment Validation

calibration.kesar@gmail.com

What we test

Classification to ISO 14644-1
0.5 µm and 5.0 µm particles
At-rest state testing
In-operation state testing
Sampling location calculation
Cleanrooms and clean zones
LAF units and isolators
Pass boxes and RLAF units

What you receive

Classification report with raw counts
Sampling location layout drawings
Acceptance criteria versus results
Particle counter calibration certificate

WHY IT MATTERS

Why particle count (nvpc) testing matters
for Gujarat's industries.

Documented, repeatable testing shows your controlled environments perform as designed.

Clear room classification

Counts at each sampling location are evaluated against the ISO class or GMP grade, giving a straightforward pass or fail result for every room tested.

Spot contamination sources

Location-by-location results highlight areas with elevated counts, which helps trace problems to a filter, a door, a process step or operator movement.

Reliable instrument data

Particle counters calibrated to ISO 21501-4 give the counting efficiency and sizing accuracy that inspectors expect to see behind classification data.

HOW WE WORK

How our Ahmedabad lab works with you.

Every engagement follows the same disciplined steps, so results are consistent and audit-ready.

01
Scope your requirement
Share your instrument list, rooms or systems and the standards you work to. We confirm parameters, ranges and acceptance criteria before anything is scheduled.
02
Plan the work
We agree dates, on-site or in-lab handling and the protocol to follow, so production and QA know exactly what will happen and when.
03
Measure with traceable standards
Qualified engineers carry out the work using calibrated reference instruments traceable to national standards, recording raw data as they go.
04
Report and certify
You receive clear certificates and reports — results, uncertainty or acceptance criteria, and traceability — ready for audits and regulatory inspections.

FREQUENTLY ASKED

Particle count (NVPC) testing in Ahmedabad: your questions.

Can’t find what you need? Call +91 63579 03105 or email calibration@kesartesting.com.

How many sampling locations are required under ISO 14644-1?

ISO 14644-1:2015 gives the minimum number of sampling locations based on the floor area of the cleanroom or clean zone, using a table in Annex A. The room is divided into sections of roughly equal area, with one location in each. Additional locations may be added at critical points identified by risk assessment.

What is the difference between at-rest and in-operation testing?

At rest means the room is complete, with equipment installed and running, but without personnel present and no process activity. In operation means the room is functioning in its normal way with the specified number of personnel working. EU GMP Annex 1 sets different particle limits for each state, so both are usually tested.

Which particle sizes are counted for GMP cleanroom grades?

EU GMP Annex 1 and Schedule M grade limits are expressed for particles of 0.5 µm and larger and 5.0 µm and larger. ISO 14644-1 classes can be specified at other sizes too, but these two are the standard sizes for pharmaceutical cleanroom grades. The protocol should state the sizes and limits used for each room.

Is NVPC classification the same as routine particle monitoring?

No. Classification is a formal test under ISO 14644-1 that confirms a room meets its class at a point in time. Routine monitoring, covered by ISO 14644-2 and Annex 1, tracks particle levels continuously or at set intervals during normal use, with alert and action limits, to show the room stays in control.

KEEP EXPLORING