Clean room Inspection services
FineLab and Environmental Consultancy LLC conduct Cleanroom Inspection as per ISO14644 & EUGMP standards and includes the following:
Air velocity and volumetric flow rate measurement
Air velocity and
volumetric flow rate are measured
by first using a device like an anemometer or Pitot tube to
determine the air's speed, then
measuring the cross-sectional area
of the duct, and finally multiplying
these values: Volumetric Flow Rate
(Q) = Average Velocity (V) × Cross-
sectional Area (A). This calculation
provides the volume of air moving
through a duct per unit of time, such
as cubic feet per minute (CFM).
Room differential pressure testing
measures the air pressure
difference between two adjacent spaces to ensure controlled
airflow, which is critical for
preventing contamination in
cleanrooms, isolation rooms, and
operating theaters. The testing is
performed using a differential
pressure gauge or monitor, with a
typical goal of maintaining a positive
pressure in cleaner or higher-risk
areas to push air out and away from
contaminants.
Filter integrity leak testing (DOP method)
uses a dispersed oil
particulate (aerosol) to verify the proper installation and sealing of
HEPA (High Efficiency Particulate
Air) and ULPA filters in critical
environments. The process involves
generating the test aerosol
upstream of the filter and then
scanning the downstream side with
a particle counter or photometer to
detect any leaks, ensuring the filter
and its housing maintain their
integrity against contamination.
Airflow balancing
is the process of
testing and adjusting HVAC systems
to ensure that each room or zone
receives the correct amount of
heated or cooled air, creating
consistent comfort and optimizing
energy efficiency. A qualified
technician uses specialized tools,
such as anemometers, to measure
airflow and identify problems like hot
or cold spots,
adjusting dampers, filters, and ducts
to achieve the desired air
distribution.
Long-term Environmental Monitoring Programs (LEMP)
For regulatory compliance and operational
Temperature monitoring
Temperature and humidity of the
room is monitoredusing digital
thremohygrometer by placing it at 4
corners of the room and also at the center of the room.
Airflow visualisation
allow for the
visual characterization of the
“Contamination Control Effect” in
cleanrooms or clean zones. The
movement of HEPA filtered air
dictates the contamination control
effectiveness of the overall
installation. Factors such as cleanroom design, HEPA filter placement, air return locations,
equipment configuration, furniture
locations, personnel movements,
manufacturing operations all can
impact air patterns. Because air is
transparent, it is difficult to
determine this contamination control
effect and unfavorable (adverse) air
patterns may go undetected. Airflow
visualization studies provide the
analysis, evaluation and
documentation of air movement in
cleanrooms and clean zones.
Pragmatic contamination control
requires that comprehensive airflow
visualization studies are performed
under all operating conditions,
including simulations of operations.