To maintain the desired SAL at the plant is task which demands great care and control over Man, Machine & Method. This summarize work will definitely help you as hand note.
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โข GOOD: having required qualities of high standards .
โข ASEPTIC: free from contamination, caused by harmful bacteria,
virus, fungi. A fully careful controlled condition.
โข PRACTICES: A actual application or use of an idea, method, belief
theories to relate with.
Good Aseptic practices
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โข Contamination is a process or act that causes materials or
surfaces to be soiled with contaminating substances.
โข Contaminants are generated from five basic sources:
โ Facilities โ Machine
โ People โ Man
โ Tools โ Method
โ Fluids โ Material
โ product being manufactured.
What is Contamination ?
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โข In cleanroom technology, contaminates are understood to be not
only dust particles in the strict sense, but any disturbing effects of a
solid, liquid, gaseous, thermal or electromagnetic nature capable of
having a negative influence on the course of a process and the
quality of a product.
โข The size of particles is defined in microns (abbreviated ยตm) i. e.
โsmallโ in Greek. One micron is a millionth of a meter or a
thousandth of a millimeter.
โข As a comparison, one human hair has a diameter of about 60 - 80
microns; all particles from about 5 microns down are present in the
air and are therefore called suspended particles.
Definition of Contamination
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โข What can HVAC do?
โข HVAC system performs four basic functions:
1. Control airborne particles, dust and micro-organisms
โข Thru air filtration using high efficiency particulate air (HEPA) filters.
โข They filter particles as small as 0.3 microns with a 99.97% minimum
particle-collective efficiency
HVAC - Heating, Ventilation & Air Conditioning
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2. Maintain room pressure (delta P)
โข Areas that must remain โcleanerโ than surrounding areas must be kept
under a โpositiveโ pressurization,
โข This is achieved by the HVAC system providing more air into the
โcleanerโ space than is mechanically removed from that same space.
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3: Maintain space moisture (Relative Humidity)
Humidity is controlled by cooling air to dew point temperatures or by
using desiccant dehumidifiers.
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4. Maintain space temperature โ
โข Temperature can affect production directly or indirectly by fostering
the growth of microbial contaminants on workers.
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โข A cleanroom is an area set apart by a wall or similar partition, whose
degree of cleanliness is achieved by purified air ventilation.
โข Cleanroom environment is pressurized to outside area.
The ISO definition of clean room is: Room in which the concentration of
airborne particles is controlled, and which is constructed and used in a
manner to minimize the introduction, generation and retention of particles
inside the room, and in which other relevant parameters, e.g. temperature,
humidity and pressure, are controlled as necessary.
Clean Room Architecture
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Air Current Control
โข type of cleanroom (turbulent, with low turbulence)
โข cleanroom layout
โข arrangement of incoming and outgoing air flows
โข technological environment
โข particle-proof room divisions
โข maintenance of pressure
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Staff
โข rules of behavior, discipline
โข speed of movement
โข organization of work activities
โข clothing appropriate for cleanroom
โข regular decontamination of cleanroom clothing
โข entry and exit procedures (airlocks)
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Workplace
โข cleanroom compliant infrastructure
โข ergonomic design
โข arrangement of incoming and outgoing air flows
โข aerodynamics of equipment
โข sources of heat
โข โblind-spotsโ in current
โข cleanliness of surfaces
โข cleaning throughout production
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โข process layout
โข sequence of procedures
โข keeping process media clean (gases, chemicals, DI water, solvents etc.)
โข process equipment, production fittings
โข monitoring procedures
โข inward and outward movement of materials through airlocks
Process
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Cleanroom Clothing
โข Particle Emission from Persons
โข Function of Cleanroom Clothing
โข Evaluation Criteria for Cleanroom Clothing
โข Recommended Cleanroom Clothing
โข Dressing according to Cleanroom Standards
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โข Laminar flow principle involves double filtration of air through coarse
Prefilters (upto 5 microns) and HEPA filters (down to 0.3 microns) for
filtration of Biological & Particulate contaminants.
โข A constant uni-directional air flows either Horizontally or Vertically, is
drawn from atmosphere and passed through pre and HEPA filters on to the
work surface.
Laminar Flow Cabinet
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โข Care is taken when selecting and using commodity items in
cleanrooms.
โข Wipers, cleanroom paper and pens and other supplies that
service the cleanroom should be carefully screened and
selected
โข Mops, Wipes, Paper, Pen etcโฆ.
Commodities