Compressed Air test
Accurate Labs has understood the importance of product risks by monitoring the air against quality standards, testing, giving accurate results and advising the risk factor to the clients. Testing and monitoring of compressed air and other process gases such nitrogen, oxygen, argon and carbon dioxide that come into direct contact with pharmaceutical products is vital to assuring the quality and safety of those products. Compressed Air validation is a critical component in the production of pharmaceutical industry and effects on the quality of the end product. It is used by operatives working in a number of industrial sectors including oil and gas, Pharmaceutical, Manufacturing, nuclear, diving and in medical applications. Compression of ambient air concentrates the normal contaminants already present in the air and can also introduce other contaminants such as Oil vapor, Condensed water and Bacteria.
Accurate Labs validate Compressed Air in all kinds of industries as the demand for compressed air quality depends on its usage, we can also validate Compressed Air in some industries where they require extremely high quality air along with Breathing Air Validation, Instrument Air Validation and Nitrogen Gas Validation.
Compressed air is air kept under a pressure that is greater than atmospheric pressure. It serves many domestic and industrial purposes. Compressed Air is a vital energy source and is utilized in multiple operations in industries. When properly treated, Compressed air is regarded as a safe, clean utility, as compared to other energy sources. Compressed provides the energy source for pneumatic conveyers that transport liquids, powders and moisture sensitive product throughout the plant.
The Quality of Compressed air is important to ensure that product is safe. The most important parameters in specifying Compressed air quality are:
The Dew point temperature or Saturation
temperature can be defined as the temperature
at which Water vapour begins to condense. The
quantity of any gas in a mixture can be
expressed as a pressure. The major components
of compressed air are nitrogen, oxygen and
water vapor, so total atmospheric pressure is
composed of the partial pressures of these
three gases. While nitrogen and oxygen exist
in stable concentrations, the concentration of
water vapor is highly variable and must be
measured to be determined. Gas of unknown
water vapor concentration is passed over a
temperature controlled surface. The surface is
cooled until condensation forms. The
temperature at which condensation forms is
called the “Dew Point temperature.” Because
there is a unique correlation between
temperature and saturation vapor pressure,
measuring the Dew point temperature of a gas
is a direct measurement of the partial
pressure of water vapor. Desiccant drying
systems absorb water vapor from the air stream
and can produce air with a Dew point of -40°F
(–40°C) and drier if required. Dew point
temperatures in compressed air range from
ambient down to -112°F (–8 °C), sometimes
lower in special cases.
A Compressed Air Oil content test is a measure
of the Oil Content of Compressed air systems.
The test can accurately determine the amount
of Oil flowing in a Compressed Air stream and
assess whether the system complies with
relevant requirements. Many Compressed air
systems are supplied using lubricated
compressors. These Compressors often blow
small particles of Oil throughout the system,
which can cause a range of problems for
components when the Oil emulsifies with water
in the system. Oil free air is generally
required for an Compressed Air System and an
Oil content of less than 0.01 mg/m3 is
generally specified.
Compressed air is used in a broad range of
applications in the industries and used in the
mixing of ingredients, cutting, sparging,
drying of product, transporting/propelling
product through processing systems and
packaging of final product. In many of these
applications, compressed air is in direct
contact or indirect contact with product and
the impurities in the compressed air may
contaminate the product which can result in
change of color and taste, reduced shelf life,
in addition to exposure to bacteria and other
microorganisms can result in product recalls.
Compressed air, which is generated on site by
pulling in ambient air and compressing it,
contains water vapor, particulate matter
(atmospheric air typically contains 140-150
million dirt particles/m3). More importantly,
the filtration systems that are employed are
designed to protect process equipment from
large slugs of water, oil, rust and pipe scale
with a nominal rating of 25 to 40 micron and
are not capable of removing submicron
contaminates. Compressed Air is generally
filtered to remove Particulate Matter to a
level less than 0.02 mg/m3 (size 100% <0.01
micron).
All atmospheric air contains some water vapor
which will begin to condense into liquid water
in the compressed air or gas system when the
air or gas cools past the saturation point,
i.e., the point where it can hold no more
water vapor. The condensed moisture must be
removed by a separator and trap. Moisture in
compressed air used in a manufacturing plant
causes problems in the operation of pneumatic
air systems, solenoid valves and air motors.
This moisture causes rust and increased wear
of moving parts as it washes away lubrication.
Moisture adversely affects the color,
adherence, and finish of paint applied by
compressed air. Corrosion of air or gas
operated instruments from moisture can give
false readings, interrupting or shutting down
plant processes. The malfunctioning of these
controls due to rust, scale, and clogged
orifices can result in damage to product or in
costly shutdowns. Additionally, the freezing
of moisture in control lines in cold weather
commonly causes faulty operation of controls.
Moisture content should be less than <0.01%
for Compressed Air System.
The manufacturer may not realize that the
compressed air system could be harbouring
microorganisms. When the air supply system is
operating, it may unleash contaminants which
could adversely affect the product, including
operational characteristics, by compromising
sterile claims, or product aesthetics. The
condition or the quality of the supplied air,
from a microbiological standpoint, may not be
obvious unless microbiological testing is
performed. A simple air impaction microbial
assay of compressed air lines, however, will
alert the manufacturer to the various types of
viable microorganisms that might be present.
Manufacturers of medical devices,
pharmaceutical operations, or those classified
as sterile fill, are constantly assessing the
environmental impact on the product during the
manufacturing process. This assessment usually
includes the facility, the equipment, and the
personnel involved in the assembly process.
Sampling may include, but is not limited to,
surface sampling, particulate counts, water
analysis, and product testing. However,
compressed air can easily be overlooked if not
initially inserted into the environmental
monitoring protocol or identified by an
experienced environmental scientist. For
Compressed Air System, Viable count should be
<100CFU.