Critical Parameters
for Cleanroom Monitoring
Continuous monitoring supports validation and compliance, and
ensures an optimal environment every day
Validation is an important process to ensure
cleanrooms meet specific standards to be
classified according to the International Standards
Organization (ISO). ISO classifications regulate the
degree of cleanliness, and are defined by factors
such as particle count and size, and air changes
rates, among others outlined in ISO 14644-1. These
classifications ensure the integrity of the products,
ranging from pharmaceuticals to semiconductors,
contained in the cleanroom. The validation process
requires inspection and testing, and laboratory
organizations must also perform ongoing
monitoring to demonstrate continued compliance
with standards. A comprehensive cleanroom
monitoring strategy that combines data acquisition,
analysis, and reporting supports validation and
ongoing compliance efforts, and protects valuable
scientific work.
Critical parameters for validation and monitoring
Cleanroom ISO Classes (1-9) are based on air
cleanliness by particle concentration, with specific
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maximum allowable concentrations (particles/m3)
for particles from 0.1 to 5 µm. Particle counts must
be performed for a cleanroom to be classified in
accordance with ISO 14644-1, and must be repeated
periodically to demonstrate ongoing compliance.
While particle counts are a requirement, there are
a myriad of other optional tests and parameters
outlined in the ISO standards. Depending on the
applications carried out within the cleanroom, tests
for ultrafine airborne particles, macroparticles,
airflow, air pressure difference, temperature,
humidity, and more may be appropriate, and can
be incorporated into a monitoring program. In
fact, monitoring multiple parameters in addition to
particle count can help to ensure a more consistent
cleanroom environment.
Where cleanroom testing falls short
The airborne particle count for classification and
test measurement is made to certify the cleanliness
classification of the cleanroom installation in
accordance with ISO 14644-1, or for periodic
monitoring according to ISO 14644-2. Despite
detailed test procedures that specify the number of
sample points, sampling locations, apparatuses, and
data required for reporting, performing these tests
at the minimum required frequency only provides
a snapshot of the cleanroom environment. Without
continuous data for particle count and several
other critical parameters, it is impossible to identify
abnormalities that can impact experiments and
products on a daily basis.
Challenges also arise when laboratories rely
on multiple, discrete, monitoring devices and
platforms to obtain a complete understanding of
the cleanroom environment. Manually compiling
data from individual platforms is extremely time-
consuming, and makes it difficult to evaluate multiple
parameters together to identify the root cause of
any abnormalities. For example, correlating particle
counts with occupancy states or other ambient
parameters may provide more relevant, actionable
data than a single elevated particle count. Further,
many busy laboratories simply lack the human
resources and expertise required to perform the
detailed analyses necessary to gain valuable insights
from environmental monitoring data.
which staff were present while measurements were
being taken. The system is designed with flexibility
in mind, and XiltriX experts can assist in creating a
perfectly tailored solution, with numerous options for
expansion as required.
A comprehensive monitoring solution goes beyond
alerts and notifications, and leverages monitoring data
to provide predictive analytics and automated quality
reports. The XiltriX SafetyNet team actively monitors
deviations and alerts customers of potential problems
before equipment failure occurs. The team also
creates custom reports to meet specific quality and
compliance requirements, and can assist in generating
the necessary information in the event of an audit.

Relying on the building management system for
cleanroom monitoring is also insufficient. These
systems are designed to monitor and control power,
lighting, and ventilation systems, but are not designed
to acquire scientific data, create trend reports, or
provide analyses to support informed decisions.
A comprehensive, continuous monitoring solution
In the highly controlled cleanroom environment,
fluctuations in any of a myriad of critical parameters
can have significant consequences for the
experiments and products contained within. XiltriX
solutions provide data acquisition, analysis, and
reporting on all equipment and environmental
parameters, to ensure an optimal cleanroom
environment every day.

XiltriX solutions are designed for reliable,

comprehensive monitoring of numerous cleanroom
(and laboratory) parameters in a single software.
XiltriX combines data acquisition from numerous
sensors, assets, and equipment, with data analysis,
reporting and documentation. This powerful
solution not only facilitates validation and supports
ongoing compliance, it also provides real-time data
for numerous parameters that affect research and
product integrity.

In addition to particle counting, XiltriX monitoring

solutions track temperature, relative humidity,
differential air pressure, VOCs (volatile organic
compounds), various chemicals, light intensity,
vibration, and numerous other parameters that
provide valuable insight into the cleanroom
environment. A red or green LED light provides a
quick visual indication that individual parameters are
within specified ranges. The system can also integrate For more information visit:
information with badge reader access, to determine www.xiltrixusa.com

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