hygiene control in the brewing industry with reference to air particle control
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HYGIENE CONTROL IN THE BREWING INDUSTRY WITH REFERENCE TO AIR PARTICLE CONTROL Environmental monitoring in the Food and Beverage Industry South African Breweries January 2012 Stephen Marrs IEPSA. What is a particle? - PowerPoint PPT PresentationTRANSCRIPT
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HYGIENE CONTROL IN THE BREWING INDUSTRYWITH REFERENCE TO AIR PARTICLE CONTROL
Environmental monitoring in
the Food and Beverage Industry
South African BreweriesJanuary 2012
Stephen Marrs IEPSA
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What is a particle?
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
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Why the concern about particles?
For security & quality reasons during production:
Pharmaceutical industry: particles in vaccines cause occlusion of blood vessels
Medical devices: poor adhesion of coating in stents creates emboli
Medical films: contamination prevents complete image recovery
Electronic industry: particles on circuit boards create false contacts
A PARTICLE WILL BECOME A CONTAMINANT!THE CONCENTRATION OF PARTICLES INDICATE THE LEVEL OF CONTAMINATION IN A CRITICAL AREA…..
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Particle sizes
Diameter in micrometer (µm)
Sand: 80 – 2000 µmHuman hair: 100 µmMeal: 5 – 10 µmBacteria: 0,2 – 2 µmCigarette smoke: 0.01 – 1 µmVirus: 0.003 – 0,05 µm
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Sources of particles?
In a cleanroom the human being is the biggest contaminator:
Dead skin cells are discarded continuously
Exhalation carries a mixture of gases
In critical areas operators need to ware cleanroom clothing
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Emission of particles
Emission of particles >0,5 µm per minuteNormal Clothes Cleanroom clothes
No movement 100.000Light movement 500.000Going to sit 1.000.000Walking 5.000.000 100.000Running 7.500.000 1.000.000Running fast 10.000.000
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Sources of human particles
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Standards for particle counting
• ISO 14644 General standards for all cleanrooms Particle limits for sizes/classes
• EU cGMP Industry specific (pharmaceutical) More stringent levels At rest v. operational
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ISO 14644-1 air borne particle cleanliness classes for clean rooms
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Good practices for particle counting
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The cleanroom layout:
the layout has to match the operational situationthe equipment will have a fixed positionoverview of the different critical areasthe areas will get a proper identification: (alphanumeric) namealso the sample locations will be identified on the CR layoutboth the areas and the sample location names can be set on the counteroperators need to be trained to use the designated sample locations to make representative samples
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How many sample locations in a clean zone? ISO 14644 – 1 has a simple formula:
√A = x, A = surface in m²
x = minimum number of sample locations acc. to ISO 14644-1Sample locations are spread equidistant, at the highest risk for contamination A simple example for a “cleanzone” of 16 m²:
-4 locations ISO 5 @ ≥ 0.5 micron
-Class limit is 3520 particles/m³
After revision 14644: 8 sample locations!!
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Position of the Isokinetic probe
Designed to sample air with a nominal velocity of 0,5 meters per secPointing into the airflow at the sample locationVertically upward if direction of the airflow is unknownEnvironmental measurements: at a height of 1,5 meter and upwardIn a process measurement: in the work field of the operator to monitor
the risk for contaminationCheck the probe on deformations and cleanliness:
-a stainless steel probe is more robust-autoclavable
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The zero count filter
Will hold particles bigger than 0,2 µmEasy tool to check the proper working of the counter:
-less than 1 count in 5 samples of a minute-repeat the test on a regular basis, once per week
Second function of the filter: to purge the counter-if you go from a ISO 9 Class to a ISO 5
do a purge action to start with a clean optical system
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How does a particle counter work?
There are three basic elements in all particle counting systems:1) The sensor
The sensor is the device that detects particles using a light scattering method of detection.2) The sample delivery system
The sample is delivered to the sensor by the use of a vacuum system.3) The counting electronics
The particle counts are processed and displayed on a screen.
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Optical System Cross-Section
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Biotest solutions
Handheld Particle Counter
• Easy and safe operation• Individual Channels 0,3µm -
10µm• 10.000 records stored in memory• Windows CE & USB connection• Ideally suited for monitoring
Processes and filters
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Thank you