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Review Article
WORLD JOURNAL OF PHARMACEUTICAL
Aditya et al. World Journal of Pharmaceutical and Medical Research
AND MEDICAL RESEARCH ISSN 2455-3301
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Natrajan S Iyer, B.K. Jogale, Dr. Aditya P. Sharma*, Arun Kumar, Rekha Mehta, and Rahul K. Singh
ABSTRACT
This technical article is written to understand the criticality of compressed air (CA) used in pharmaceutical
manufacturing plant. ISO 18573.1:2010 and other relevant guidelines showing the impact on pharmaceutical
product. Generation, purification and distribution of CA system are discussed with different testing procedures for
dew point and also to check the dew point with pressure and temperature graph. Most importantly future of
compressed air system is analyzed. Authors feel that the evolution of compressed air system which is taken place
with last two decades will be followed by compressed air validation.
KEYWORDS: CA- Compressed Air, Regenerative desiccant dryer, Refrigerant dryer, Heat Compression dryer,
m- micro meter, Dew point, Solid particulate.
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and other half revelation discharge valve is activated and to avoid excess dust entry. Open drains can be avoided
compressed air is discharged. This simple system is and exhaust fan can be fixed to avoid hot air inlet to
known as single stage compression system, There is also suction filters..
compressed air system in which discharge from one
discharge to other compressor as suction thereby final Air Quality Standards and Guidelines
pressure can increase. ISO for air quality standards ISO 8573 series of
guidelines to specify and testing of compressed air.
ISO 8573-1:2010 specifies the purity of compress air
required at a particular point in compressed air system.
ISO 8573 part 2 to 9 specifies testing compressed air
system for one or more specific contaminants.
ISO 8573-1:2010 contain ISO 8573-1:2010 class 1.2.1 Class 2 Dew point or Water A pressure dew point
1.2.1 Means:- should be -400c and no liquid water is allowed.
Class 1 Solid Particulate -See the chart for class 1 Class 1 Oil- Each cubic meter of air not more than
particulate i.e. 20,000 particles of 0.1 to 0.5 m and 0.05mg/m3 oil is allowed.
400 particles of 0.5-1 m range.
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Adsorbent drier with two towers A and B. Compressed Pipe line for distribution is made of SS304. In the point
air is passed through to remove suspended moisture and of use there is 0.2m sterile filter in series with dust
stored under pressure in receiver @ 7-8 kg/cm2 discharge remove then it is connected to process equipment. (Fig.)
through pressure reducing valve to reduce to 5-6kg/cm2
passed through series of filters 5m and 10m.
All drains needs to be taken outside. Types of Compressed Air Dryers: Dryers are three
Compressed air contaminants can be divided as solids, types:-
water and oil according to
ISO 8573-1:2010
Solid can come from:
Micro organism
Atmospheric dirt
Rust
Pipe scales
Water can come from:
Water vapors
Condensed liquid water
Water aerosol
Regenerative Desiccant Dryer: In regenerative
Oil can come from:
desiccant dryer desiccator adsorbs moisture in the air
Oil vapors
stream. The moisture adheres to the desiccant, collecting
Liquid oil
in the thousands of small pores within each desiccant
Oil aerosol bead. The composition of the desiccant is not changed
and the moisture can be driven off in a regeneration
Measurement of oil mist presence in compressed air process by applying dry purge air and the application of
discharged through reciprocating non-lubricated heat.
compressor.
According to ISO 8573-1:2010 class 1.2.1, It has two towers. One tower dries the air from the
3 compressor while the desiccant in the other tower is
Maximum allowable oil presence = 0.05 mg/m being regenerated after the pressure in the tower has been
Let the compressor capacity be = 300 CFM = 0.3 reduced to atmospheric pressure.
m3/min It has -400F to +1120F (-400C to -800C) dew point range.
Presence of oil mist per minutes = 30 m3 x 0.05 mg/m3
= 1.5 mg
1.5mg is present in 300 CFU of compressed air
You can see how it increases exponentially and keeping
oil passing into system is very important Compressed air
system contains:
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Air Receiver: Receivers are used to provide surge In any mixture of gases, the total pressure of the gas is
capacity meet peak capacity. Receiver should provide for the sum of the partial pressures of the component gases.
short time for 60 to 90 sec. major advantage with large This is Daltons law and it is represented as follows:
receiver we can have small compressor other advantages Ptotal = P1 + P2 + P3
improved system availability. The quantity of any gas in a mixture can be expressed as
a pressure.
Capacity of receiver: Normally capacity of receiver 6 to
10 time compressor peak capacity. Dew point temperature, Td to which air must be cooled
for water vapor in it condense into dew. At any
Why compressed air is dried? temperature there is a maximum amount is called water
All atmospheric air contains some water vapor which vapor saturation pressure. Addition of more water vapor
will begin to condense into liquid water in results in condensation.
the compressed air or gas system when the air or gas
cools past the saturation point, i.e., the point Measurement of dew point
where it can hold no more water vapor. Measurement of dew point by using temp measurement
of receiver and pressure measurement of receiver.
Dew Point: The temperature at which water vapor in the
air starts to condense or change from Note: Temperature and pressure measurement can be
Vapor to a liquid or a solid state. It is an important done with calibrated temperature and pressure
parameter to measure in compressed air line for measuring instrument in receiver using the graphical
determining how much drying is needed. chart below we can calculate dew point very easily.
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If a gas is cooled and gaseous water vapor begins to functioning of pneumatic controls. The
condense in the liquid phase, the temperature at which malfunctioning of these controls due to rust, scale,
condensation occurs is defined as the dew point and clogged orifices can result in damage to product
temperature (Td). or in costly shutdowns. Additionally, the freezing of
moisture in control lines in cold weather commonly
At 100%RH the ambient temperature equals the dew causes faulty operation of controls.
point temperature. 4. Corrosion of air or gas operated instruments from
moisture can give false readings, interrupting or
The further negative the dew point is from the ambient shutting down plant processes.
temperature, the smaller the risk for condensation and the 5. Deposits of sludge formed by dirty, wet and oily air
drier the air. act as a drag on pneumatic cylinders so that the seals
and bearings need frequent maintenance. Operation
When the operating temperature is equal to dew point is slowed down and eventually stopped.
temperature, the relative humidity is 100% RH. It 6. Moisture dilutes the oil required for the head and rod
proportional only to pressure of water vapor. Dew point of an air cylinder, corrodes the walls and slows
is not temperature dependent but only pressure response. This results in loss of efficiency and
dependent parameter. production.
7. Moisture flowing to rubber diaphragms in valves
can cause these parts to stiffen and rupture. Moisture
also can cause spools and pistons to pit.
8. Control air supplied to transmitters, relays,
integrators, converters, recorders, indicators or
Tn, m, A are constants only proportional to water vapor gauges is required to be clean and dry. A small
pressure. amount of moisture passing through an orifice can
cause malfunction of the instrument and the process
If a gas is cooled and gaseous water vapor begins to it controls. Moisture and resultant corrosion particles
condense in the liquid phase, the temperature at which also can cause damage to instruments and plug their
condensation occurs is defined as the dew point supply air lines.
temperature (Td). 9. Moisture in control line air can cause the wrong
mixture of ingredients, incorrect blend and water-
At 100%RH the ambient temperature equals the dew logged in products.
point temperature.
What contains moisture indicating desiccants?
Water vapor pressure (Pw) is the pressure exerted by the Moisture indicating desiccants contains silica gel, which
water vapor present in air or a gas. Temperature dictates when treated with a solution of cobaltous chloride, is
the maximum partial pressure of water vapor. This dark blue in color when dry. As moisture is adsorbed, the
maximum pressure is known as saturation vapor pressure color changes to pink at approximately a 0F dew point.
(Pws).Where pressure increases, dew point temperature
rises and air became moist. But when pressure decrease, Different types of dew point instruments
dew point temperature goes lower and air become drier. Dew Point Cup: It is consists of a small polished
stainless steel cup placed in a container into which you
Relative humidity (RH) can be defined as the ratio of the pass the sample air or gas. The temperature of the
partial water vapor pressure (Pw) to the water vapor polished surface is lowered by immersing dry ice (solid
saturation pressure (Pws) at a particular temperature: carbon dioxide) in an acetone solution contained in the
%RH = 100% Pw / Pws cup. The temperature at which fog appears on the cup is
Relative humidity is strongly temperature dependent as the dew point of the sample.
the denominator in the definition (Pws) is a function of
temperature. Condensation in pressurized air is a Refrigerant Evaporation Dew Point Instrument: This
problematic because it causes blockages in pipes, device permits direct gauge reading of the dew point
corrosion, breakdown etc. temperature of the sample, as determined by the
appearance of a fog on the surface of a highly polished
Damages due to presence of moisture vessel in which a refrigerant is being evaporated. Dew
1. Moisture in compressed air used in a manufacturing point temperatures can be determined at either system or
plant causes problems in the operation of pneumatic atmospheric pressure.
air systems, solenoid valves and air motors. This
moisture causes rust and increased wear of moving Fog Chamber Instrument: This device relies on the
parts as it washes away lubrication. relationship between pressure and temperature during
2. Moisture adversely affects the color, adherence, and adiabatic expansion. A sample of gas enters a small
finish of paint applied by compressed air. chamber where it is compressed, then rapidly vented to
3. Moisture jeopardizes process industries where many atmospheric pressure. The point at which fog appears
operations are dependent upon the proper
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establishes a relationship with the amount of * Oil content after filtration 0.1mg/m3.
compression, and from this the dew point may be Particulate total
calculated. Test point 1: After the filter
Test point 2: Longest pipe line in floor of each unit
Capacitance Instrument: This analyzer consists of two Frequency
strips of metal, which form the electrodes of a capacitor. 3 days one time each day
Water vapor passing across the electrodes causes a * No contamination of air due to generation distribution,
change in electric impedance and this is used as a material construction etc.
measurement of dew point temperature. Acceptance criteria
X 0.5m 100 ft3
Hygroscopic Cells: These analyzers use a sensing Particulate viable
element which contains a moisture adsorbing material. A Test point 1: After the final filter
change in the moisture content of the element is detected Test point 2: Longest pipe line at the end of the floor
by an electronic network and is used as a measurement Frequency
of dew point temperature.
3 days one time each day
Acceptance criteria
Frost Point Temperature
y 0.03 CFU/ ft3
If the dew point temperature is below freezing which is
the case in dry gas applications the term frost point (Tf)
Application of Compressed air in powder filling
is sometimes used to explicitly state that the condensing
equipment
phase is ice. The frost point is always slightly higher than
the dew point below 0C as the water vapor saturation
pressure of ice is different to water.
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outlet. It starts from the suction filter of the compressor 1. Physical Test: Description
and ends at the usage points. Compressor provides a Select side arm flask with stopper. Adjust the flow of
filter at the suction of the compressor to avoid any compressed air using regulatory valve. Connect silicone
ingress of solid particles. The compressor cylinder, tubing to sampling point and pass air for 2 minute then
during suction strokes, aspires atmospheric air through connect the tubing to container and pass the air through
the filter and compresses it to the delivery pressure. Air container for two times to wipe any previous odor if any.
before passing to the next stage is cooled to near about Now fill the container with air of moderate flow.
atmospheric temperature. Immediately put stopper to the flask. Observe the color
of gas filled into container and shall be recorded.
Compressed Air Storage and Distribution System Carefully open the flask to produce moderate flow of
Compressed air storage and distribution system consist gas. Dont direct the air stream toward the face .But
of PSA tank and Air receiver/storage tank and in deflect a portion of the stream toward the nose.
distribution system contains pipings, ball valve, needle
valve, safety valves, pressure gauges, reducer, auto drain 2. Solubility Test
traps, filter regulator, non return valve etc. Take 5.0 Liter water in a container for check the
solubility of compressed air .Use 100 ml Compressed gas
PSA Tank/Dryer: The discharge pipe from the by adjusting Rota meter on 100 ml/minute in water and
compressor shall be enter at the lower receiver at lower check the solubility of compressed air at 20C at a
flange. The supply line from the PSA to the receiver tank pressure of 101kPa (1 atm.) and shall be recorded.
of distribution shall be connected to the upper flange of
the receiver. 3. Non viable particle count
Connect the Particle Counter to compressed gas point
Air dryer consist of two tower, if one is in operation with diffuser. Take one sample (one Mtr3) of
another is regenerate the alumina. The air from the compressed gas at each point and shall be recorded.
receiver tank enter to the tower which is in operation by
opening the inlet valve, and the moisture in the 4. Measurement of dew point
compressed air is absorbed by alumina in the tower of Procedure
the dryer and air is outlet from upward valve of tower. 1. Open the Compressed air valve and let the air to be
The dry hot compressed air enter into the drained out for 1 minute.
receiver/storage tank distribution. 2. Connect the Compressed air outlet point to
connection pipe of Dew Point Temperature
2. Performance Qualification Test Plan Transmitter.
1. Prerequisite activities and documentation. 3. Insert the Dew Point Temperature Transmitter in the
2. Test Equipment Calibration Verification connection pipe.
3. SOP Verification. 4. Ensure that the probe of Transmitter is directly
4. Performance Test perpendicular to Compressed air flow.
5. Summary of the Validation studies 5. Ensure that there is no leakage in the connections as
the penetration of humidity from the Environment
Summary of the Validation studies During performance will affect the end results.
qualification of Compressed Air system, physical, chemical 6. Switch on the power supply of Transmitter and
and microbiological quality of compressed air shall be results shall be recorded
analyzed. A sampling plan will be established and
Compressed Air will be analyzed, at selected locations, 5. Gases Detection Test
on a three consecutive working days. Procedure
Gastec standard Detector tube is used for testing of
Each sample will be evaluated chemically, physically different residual gases that may be present in
and microbiologically. All microbiological results must compressed Air. Gastec Gas Detector is a pump unit
meet the Pharmacopoeial/ In-house standards. No process which can be equipped with different Detector tube
adjustments or changes will be made to the system specific for different gases.
throughout the period of this study. This compressed air
shall be monitored at the points where it directly comes in Insert the detector tube end straight into the tube tip
contact with product. It should be free from oil and breaker of the pump, then rotate the detector tube so that
objectionable gases and microbial load. the diamond cutter of the tube tip breaker scratches the
surface of the tube end.
B. Performance Qualification Experimental
Procedure Hold detector tube firmly near the tube tip breaker and
Performance Qualification of Compressed Air bend the tube towards self to break the tube tip. Confirm
Generation and distribution System shall be carried out the pump handle is fully pushed in.
for three consecutive working days as per following
methods:
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Insert the Detector tube into the rubber inlet with arrow a. Carbon Dioxide
G mark towards the gas sampling pump. b. Carbon Monoxide
c. Sulfur Dioxide
Align guide marks (red line) on the black plate and the d. Nitrogen monoxides
guide mark on the handle (100 or 50 ml depending on the e. Water Vapour
detector tube). Direct the tube end to the point of f. Oil mist.
measurement and pull out handle fully or halfway, as per
Gastec tube manufacturer guideline, to the lock position
and wait until sampling time has elapsed. Volume of
sample withdrawn can be confirmed by the flow finish
indicator on the handle. The color in the detector tube
changes depending upon the concentration of that
particular gas, as the gas is drawn in the detection tube.
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CONCLUSION
This article design to upcoming year of compressed air
system and lubrication system, for calculation of dew
point without instrument. It can calculated by
temperature and presseure will make compliance
economical. Compressed air system is versatile and have
many advantages which helps in new applications
development. Proper management and maintainenance
helps to optimize efficiency, reliability and productivity,
of the compressed air system.
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