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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GOOD ASEPTIC PRACTICES
Presented by: Hardik Mistry
QUALITY ASSURANCE

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FDA Inspection in 2015-16

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• GOOD: having required qualities of high standards .
• ASEPTIC: free from contamination, caused by harmful bacteria,
virus, fungi. A fully careful controlled condition.
• PRACTICES: A actual application or use of an idea, method, belief
theories to relate with.
Good Aseptic practices

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• Contamination is a process or act that causes materials or
surfaces to be soiled with contaminating substances.
• Contaminants are generated from five basic sources:
– Facilities – Machine
– People – Man
– Tools – Method
– Fluids – Material
– product being manufactured.
What is Contamination ?

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• 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.
• The size of particles is defined in microns (abbreviated µm) i. e.
”small” in Greek. One micron is a millionth of a meter or a
thousandth of a millimeter.
• 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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Particle Sizes and Distribution

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Proportion of the Contamination Source

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• Facilities- walls, floors, ceilings, paint and coatings, construction
material, air conditioning debris, room air and vapours, spills and
leaks.
• People- skin flakes and oil, cosmetics and perfume, spittle, clothing
debris (lint, fibres), hair.
• Tool Generated- friction and wear particles, lubricants and
emissions, brooms, mops and dusters.
• Fluids- particulates floating in air, bacteria, organics, moisture, floor
finishes or coatings, cleaning chemicals, plasticizers, deionized
water.
• Product Generated- silicon chips, quart flakes, clean room debris,
aluminium particles.
Basic Sources of Contamination

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Key Elements of Contamination Control

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• What can HVAC do?
• HVAC system performs four basic functions:
1. Control airborne particles, dust and micro-organisms
• Thru air filtration using high efficiency particulate air (HEPA) filters.
• 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)
• Areas that must remain “cleaner” than surrounding areas must be kept
under a “positive” pressurization,
• This is achieved by the HVAC system providing more air into the
“cleaner” 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 –
• Temperature can affect production directly or indirectly by fostering
the growth of microbial contaminants on workers.

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• A cleanroom is an area set apart by a wall or similar partition, whose
degree of cleanliness is achieved by purified air ventilation.
• 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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Factors Influencing Cleanliness
Incoming Air
• cleanliness class
• air speed
• air temperature
• relative humidity

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Air Current Control
• type of cleanroom (turbulent, with low turbulence)
• cleanroom layout
• arrangement of incoming and outgoing air flows
• technological environment
• particle-proof room divisions
• maintenance of pressure

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Staff
• rules of behavior, discipline
• speed of movement
• organization of work activities
• clothing appropriate for cleanroom
• regular decontamination of cleanroom clothing
• entry and exit procedures (airlocks)

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Workplace
• cleanroom compliant infrastructure
• ergonomic design
• arrangement of incoming and outgoing air flows
• aerodynamics of equipment
• sources of heat
• ”blind-spots” in current
• cleanliness of surfaces
• cleaning throughout production

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• process layout
• sequence of procedures
• keeping process media clean (gases, chemicals, DI water, solvents etc.)
• process equipment, production fittings
• monitoring procedures
• inward and outward movement of materials through airlocks
Process

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Cleanroom Clothing
• Particle Emission from Persons
• Function of Cleanroom Clothing
• Evaluation Criteria for Cleanroom Clothing
• Recommended Cleanroom Clothing
• Dressing according to Cleanroom Standards

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Particle emission form person

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Particle emission from persons

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Particle emission from persons

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Function of cleanroom Clothing

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Evaluation Criteria for Cleanroom Clothing
• Materials and Fabrics : Nontearable, Non shredding, No particle generating
• Wearing Comfort, Zips, fastening, Seams
• Chemical Resistance
• Decontamination
• Electrostatic Qualities

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Factors Limiting Activities in the Cleanroom

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Behavior According Cleanroom Standards

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Behaviour according to Cleanroom Standards

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• 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.
• 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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• Care is taken when selecting and using commodity items in
cleanrooms.
• Wipers, cleanroom paper and pens and other supplies that
service the cleanroom should be carefully screened and
selected
• Mops, Wipes, Paper, Pen etc….
Commodities

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Rules and Guidelines

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