Theory and Practice

Sheesh Gulati MeasureTest Corporation, Mumbai

What is the definition of a particle?
An object of solid or liquid composition or both and generally between 0.001 and 1,000 µm (micrometer) in size Federal Standard 209-E A solid or liquid object which, for the purposes of classification of air cleanliness, falls within a cumulative distribution that is based upon a threshold (lower limit) size in the range from 0.1 µm to 5.0 µm ISO 14644-1

What are “particles”?
Viable counts • Can be cultured • Will grow into “colonies”
– requires optimum growth medium – requires sufficient incubation

• Enumerated as
– CFU = Colony-Forming Units – VU = Viable Units

• >> Note: A living but sterile organism would not be a “viable” entity Non-viable counts • Sometimes referred to as “total count” • Includes all types of airborne material
– Solid particles – Fibres – Micro-organisms

Humans as Source of Particles

Dirt on a necklace

Tip of a ball point writer

A piece of nail polish on a 256 k DRAM chip

Humans as Sources of Particles

Hair with hair spray Hair with hair spray

Blood cells

Red Blood cells

Flakes of Flakes of skin skin

Bacteria on the head of a pin .

. Humans shed over 5million skin cells per day.A dust mite tucks into a tasty feast on a flake of human skin.

0.How Big Is a Micron? 10 micron 1 micron 0. • Time to fall 1 metre in still air for a 10 micron particle is 33 seconds • For a 1 micron particle it is 48 minutes .5 micron .1 micron 40 micron Smallest size visible to the human eye.

Instrumentation for measuring particles • Gravimetric Method – Sampler. Filter + Precision Mass Balance • Light Scattering Method (Cleanroom particle counters use this method) • Aerodynamic Particle Sizer • Electrical Mobility Analyzer • Condensation Nucleus Counter .

Why count? “If you can measure that of which you speak and express it by a number. your knowledge is meagre and unsatisfactory” -. you know something of the subject.Lord Kelvin. English physicist Even "clean" mountain air contains very roughly 106 particles per cubic foot . but if you cannot measure it.

Particle Counter …what is it? • Optical Instrument • Must move air/fluid through sensor to work • Can quantify particles from 5 nm to 1000 µm • Cannot tell you chemical composition • Results are immediate .

CNC: Condensation Nucleus Counter (used in semicon industry) .Three types: 1. OPC (Optical Particle Counter): Light Blocking (Extinction) type -.airborne particle counters (referred to as DPC –discrete particle counter in ISO 14644) 3. OPC: Light Scattering type .Liquid Particle Counters 2.

1µm 1µm 10µm 1000µm Light Blocking Light Scattering CNC 1 nm 10 100 1000 10000 100000 1000000 .Detection Ranges 0.

The nature of the scattering depends on the object properties. This change occurs in all directions -. especially the size of the object The term scattering means the light undergoes a directional change.Light Scattering Light can be thought of as a set of electromagnetic waves. Light is scattered when these waves interact with other objects.forward. backward and sideways .

THEORY OF OPERATION All of you are familiar with the sight of dust particles “floating” in a ray of sunlight falling into a room. 4. Four elements are necessary for this phenomenon: 1. 2. Sunlight to illuminate the dust particles Dust particles to reflect the sunlight Air to carry the dust Your eyes to see the dust Particle counters use the same basic principles in a “refined” manner . 3.

and and the number of pulses is equal to the number of particles .Light Scattering (cont’d) A very bright light source (laser diode. previously halogen lamp) is used to illuminate the particles Inside the sensor of the particle counter there are mirrors silvered on the inside. which pick up the scattered light and focus it on a photo-detector The photo-detector converts the bursts of light energy from each particle into a pulse of electrical energy The height of the signal is proportional to the size of the particle.

Laser Light Collection Reflector Reflector Light Trap Collection Collection Lenses Lenses Background Background Scatter Scatter Photo Photo Detector Detector (Diode) (Diode) Output Output Signal Signal .

Principles: Light Scattering Detector Detector Output Light Trap Laser Diode Mirror .

Principles: Light Scattering Detector Particle Light Trap Laser Diode Mirror .

Particle Sizing .

Disadvantages: Light Scattering More complicated construction = higher cost Characteristics of particle surface (shiny. color) affect response .

Effect of colors and surfaces on Light Scattering Dark Light Shiny .

Effect of Flow Rate on Sizing .

Typical Counter Components Sample inlet Sensor Sensor .

Typical Counter Components Sample inlet Sensor Flow Monitor Pump Filter Sample exhaust Sensor Pump .

Typical Counter Components Sample inlet Sensor Flow Monitor Pump Filter Sample exhaust Control Electronics Serial Data Out Sensor Pump Counter .

Typical Counter Components Sample inlet Sensor Flow Monitor Pump Filter Sample exhaust Control Electronics Display Printer Serial Data Out 0.3 Sensor 1410 Pump Counter Output .

Particle Counters .Hardware There are 3 general styles of airborne instruments: • Hand-held • Portable (stand-alone / trolley mounted) • Remote (for continuous monitoring) .

1 cfm (2.Handheld Counters • Battery operated • Light-weight • Optical Particle Counters • 0.83 l/min) • JIS • CE .3 or 0.5 micron • 0.

AC only Output air filtered to 0.Portable OPC • • • • • • Often put onto trolley / cart Often used to take multiple samples at one site for extended period Usually has built-in printer Memory storage for multiple samples Until recently.1 µm .2 or 0.

1 or 1.0 cfm flow rate Used individually or with manifold (specific models) .5 µm) • High Sensitivity (0.Portable Counters Two categories • Standard Sensitivity (0.1 µm or lower) Either 0.3 or 0.

3 microns (237B) 2 .1 cfm Counter • • • • • • • 0.6 channels FS209E calcs Built-in printer 100.0. 115 or 230 VAC AC/DC (battery operated) .1 CFM 0.

1 CFM PORTABLE COUNTER • • • • • • • • • 1 CFM or 50LPM 0.3 microns (3413) High speed printer 6 channels stainless steel body ISO 14644-1 calculations AC/DC (battery operated) 90 to 260 VAC input Long life laser .

Cleanroom applications of Particle Counters • • • • • • Filter testing / verification Certification of room Process verification Tracking sources of contamination Verifying gowning procedures Studying tool configuration and startup .

0 cfm or 50 lpm (1. However.1 cfm counter while validating pharma clean rooms: .FLOW RATES Airborne particle counters are available with flow rates of 0. the following would be the problems using a 0. F.77 cfm).209E /ISO 14644 does not specify using a particular flow rate.S.1cfm or 1.

e.Flow rates (contd. If the measured value was only 3 this would convert into 30 or if it is changed to 4 it would jump to 40. • In other words. This is a valid approach provided that the measured value has statistical significance i. it is 23 counts per minute or greater to provide a reliable basis.) • We would have to multiply the 1 minute measurement result by 10. the uncertainty of a spread of 10 in a total multiplied count result of 40 would amount to 25% .

thus maximising the chances of capturing any 5 micron particle that may be present.1cfm counter run for 10 minutes to get a sample volume of 1 cubic foot.1 cfm as you get 10 times the sample quantity . The draw back of this approach is that. this burst would be integrated and would not show up as significant.) • The other method would be to let the 0. • The best way to count large particles is to sample a large quantity of air.FLOW RATES (Contd. Therefore 1 cfm flow rate is better than 0. if any short term particle burst occurs during the relatively long 10 minutes count cycle.

. whereas the 0.) • In fact EU GMP Annex 1 recommends a sample volume of 1 cu.1 cfm counter would take 350 minutes ( 6 hours) to test such a volume. it is recommended that a 0.FLOW RATES (Contd.1 cfm counter would not be suitable to certify a class 100 clean room. • Based on the above.metre = 35 cft which can be tested in 35 minutes by a 1 cfm instrument.

Zero Count • Tests noise immunity • Tests for internal contamination JIS: After 30 minute purge. measure counts for 5 minutes Met One example: • less than 3 counts in 5 minutes .

the total count for the selected size range and all larger sizes Differential count .gives one beep for each particle counted.Counting Modes Cumulative count .the number of particles in the selected size channel Concentration = the number of particles per cubic foot. Concentration mode gives a quick estimation (in seconds) of the particle concentration Beep .Useful for locating leaks in filter banks .

Counting Modes Cumulative Differential Size 3 Size 2 Size 1 .

What Is the View Volume? Sample Air Flow Laser Beam That area inside the sensor where the laser beam and sample path are coincident .

Coincidence Loss The error introduced when particle density becomes so great that two or more particles are in the sensor view volume at the same time. causing two particles to be detected as one. .

Coincidence Loss Inside a Sensor •Obscuration = •Aggregation = •Single Particle .

0.3 micron at 50% counting efficiency Very high sensitivities ex 0.5 micron is adequate .3 or 0.Sensitivity The smallest size particle a counter can detect at a specified counting efficiency ex.1 micron can only be used in very clean rooms (Class 1 or Class 10) Very high sensitivity counters are expensive (helium neon laser instead of laser diode) and delicate For pharma industry.0.

3 microns and 100% at 0. ISO/CD 21501-1 describes it as the ratio of measured result of a particle counter to that of a reference instrument. 50% at 0.Counting Efficiency Counting efficiency is an expression of the probability that a Particle Counter will sense and count a particle passing through its sample volume. using the same sample The counting efficiency is 50% at the minimum reported size range and 100% at the next size range ex.5 microns . This probability is a function of size up to a certain critical size above which all particles are normally sensed and counted.

Not 2:1 Signal to Noise Ratio 0% Efficiency 100% Efficiency. At least 2:1signal to noise ratio C o u n t s Noise Level 90% Efficiency.Counting Efficiency 50% Efficiency. Below noise level Particle size Less than nominal size Greater than nominal size .

Sensor Resolution Poor resolution Good resolution Perfect resolution Assuming standard particle distribution .

1 to 3 cfm (2.4 .83 to 80 lpm) .Isokinetic probes • Minimize turbulence • Matching air flow with particle counter flow rate • Different size openings for counters with different flow rates 80 -120 fpm (0.6 m/sec) 0.0.

6 m/sec) Flowrate 0.5 1.1 cfm (2.0 cfm (56 – 84 lpm) Size (inches) 0.0 cfm (28.83 to 80 lpm) .3 lpm) 2.25 Size (mm) 12 33 2 50 .1 to 3 cfm (2.4 .55 0.83 lpm) 1.0 – 3.0.Isokinetic probes 80 -120 fpm (0.

Sign up to vote on this title
UsefulNot useful