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

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

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…..

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

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

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

Sources of human particles

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

ISO 14644-1 air borne particle cleanliness classes for clean rooms

Good practices for particle counting

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

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!!

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

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

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.

Optical System Cross-Section

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

Thank you