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? 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 µm Human hair: 100 µm Meal: 5 – 10 µm Bacteria: 0,2 – 2 µm Cigarette smoke: 0.01 – 1 µm Virus: 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 minute Normal Clothes Cleanroom clothes No movement 100.000 Light movement 500.000 Going to sit 1.000.000 Walking 5.000.000 100.000 Running 7.500.000 1.000.000 Running 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 situation the equipment will have a fixed position overview of the different critical areas the areas will get a proper identification: (alphanumeric) name also the sample locations will be identified on the CR layout both the areas and the sample location names can be set on the counter operators 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 14644-1 Sample 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!! The fundamental objective of air quality monitoring is to collect data that can be used to make informed decisions to best manage and improve the environment.

Position of the Isokinetic probe Designed to sample air with a nominal velocity of 0,5 meters per sec Pointing into the airflow at the sample location Vertically upward if direction of the airflow is unknown Environmental measurements: at a height of 1,5 meter and upward In a process measurement: in the work field of the operator to monitor the risk for contamination Check 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 µm Easy 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