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MICROBIOLOGY
By ꜱᴀɴᴊɪᴠ ᴍᴀʟɪ
ASEPTIC AREA
UNIT_4
Contents
● Designing of aseptic area
● Laminar flow equipments
● Study of different sources of contamination in
an aseptic area
Designing of Aseptic
area
What is ASPETIC?
➢Aseptic means “free from living
microorganisms" that can cause
disease.
➢The word septic means “infected” (the
prefix a- in aseptic means “not”).
ASEPTIC AREA :
❖ It is a room within a clean area designed, constructed,
serviced, and used for controlling and preventing
microbial contamination of the product.
❖ In these areas it is mandatory to avoid provisions for
dust to enter…
❖ Aseptic technique are used to prevent the acess
of microbial & particulate contaminants into
opthalmic and parental product…
Aspetic area are divided into 4 grades
according to their operations
● Grade A - High Risk Operation Eg Filling and making Aseptic
transfer
● Grade B - Background area of Grade _A Eg Preparation and
Transport
● Grade C - Preparation of Sterile solution to be filtered
● Grade D - Cleaning of equipment Handling of components
Factors for designing Aseptic
area
• In aspetic area all doors should be
airlocked.
• Aspetic area should as far as possible
from the normal areas to avoid unrelated
persons.
• All surfaces,walls, roofs should be smooth,
unbroken free from any cracks,to
minimize the deposition of microbes.
• Sliding doors are not allowed in aspetic area,
Swing doors are allowed which is airlocked.
• It should open in the flow direction of air
(+ve air pressure to -ve air pressure)
• There are 2 doors in aspetic area but both
doors can't open at a same time.
• All utilities (pipes, ducts etc…)should be
installed in such a way that they don't create
recesses,unsealed opening.
• Changing rooms should be designed air locked
and physically separated to minimize Microbial
contamination.
• A filtered air supply should be used to maintain
a postive air pressure relative surrounding.
• HEPA - (High Efficiency Particulate Air)Filters
are installed to filter the air and then which is
supplied to aspetic rooms.
• It passes the air in aspetic area,which is free
from microrganisms.
LAMINAR FLOW
EQUIPMENT
LAMINAR FLOW EQUIPMENT
• Also Known as Laminar air flow
/Laminar flow cabinet /Tissue culture
hood /clean benches.
• It is enclosed bench Designed to
prevent contamination of
microorganisms at time of
biochemical testing, performing
reaction,also use for sensitive
materials.
• It consists of filter pad,a fan(blower)&a
HEPA filter and 1 laminar air flow
bench.
• Air is passed though a HEPA filter which
remove all airborne contamination to
maintain sterile condition.
• It also consist switch for UV light,
Visible light and for motor.
• It is made of SS with no gaps or joints.
Types of Laminar Flow cabinet
Horizontal Laminar air flow Vertical laminar air flow
Working :
• Firstly on the UV light about 30min to sterile
the laminar flow…
• Then wipe the working surface with ethanol
then use it.
• Then on the motor,the blower suck the air
through the filter pad where dust is trapped.
• After that pre filter air has to pass the HEPA
filter where microbes are removed.
• Sterile air flow into Working area.
Advantages
This system is portable
Helps to reduce turbulence
Disadvantages
It is expensive
UV rays are harmful to health
Sources of Contamination
Sources :
• Atmosphere
• Operator
• Raw material
• Equipment
Atmosphere
• Air is the major source of
contamination as it contains dust
particles, microbes,spores etc…
• It may reduced by chemical
disinfection,UV light, filteration and
gaseous agent and also by airlocked
doors.
Operator
• The skin, hair and clothing of the
operator are potent source of
microbial contamination.
• Operator do any manual
contamination,may be due to lack of
training or focus.
Raw material
• It a cone for a high proportion of
microbial contamination into
pharmaceutical products (water
is the major source)
• It may be due to improper
sampling inadequate storage
condition
Equipment
• The equipments and utensils used in
a processing, holding, transferring
and packaging are also common
source of contamination of aseptic
area.
• It is due to improper design materials
lead to corrosion improper cleaning
lack of sterilization etc…
THANK YOU ❤️
If you want to shine like a sun, first
burn like a sun.

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Microbiology of Aseptic Areas

  • 3. Contents ● Designing of aseptic area ● Laminar flow equipments ● Study of different sources of contamination in an aseptic area
  • 5. What is ASPETIC? ➢Aseptic means “free from living microorganisms" that can cause disease. ➢The word septic means “infected” (the prefix a- in aseptic means “not”).
  • 6. ASEPTIC AREA : ❖ It is a room within a clean area designed, constructed, serviced, and used for controlling and preventing microbial contamination of the product. ❖ In these areas it is mandatory to avoid provisions for dust to enter… ❖ Aseptic technique are used to prevent the acess of microbial & particulate contaminants into opthalmic and parental product…
  • 7.
  • 8. Aspetic area are divided into 4 grades according to their operations ● Grade A - High Risk Operation Eg Filling and making Aseptic transfer ● Grade B - Background area of Grade _A Eg Preparation and Transport ● Grade C - Preparation of Sterile solution to be filtered ● Grade D - Cleaning of equipment Handling of components
  • 9. Factors for designing Aseptic area • In aspetic area all doors should be airlocked. • Aspetic area should as far as possible from the normal areas to avoid unrelated persons. • All surfaces,walls, roofs should be smooth, unbroken free from any cracks,to minimize the deposition of microbes.
  • 10. • Sliding doors are not allowed in aspetic area, Swing doors are allowed which is airlocked. • It should open in the flow direction of air (+ve air pressure to -ve air pressure) • There are 2 doors in aspetic area but both doors can't open at a same time. • All utilities (pipes, ducts etc…)should be installed in such a way that they don't create recesses,unsealed opening.
  • 11. • Changing rooms should be designed air locked and physically separated to minimize Microbial contamination. • A filtered air supply should be used to maintain a postive air pressure relative surrounding. • HEPA - (High Efficiency Particulate Air)Filters are installed to filter the air and then which is supplied to aspetic rooms. • It passes the air in aspetic area,which is free from microrganisms.
  • 13. LAMINAR FLOW EQUIPMENT • Also Known as Laminar air flow /Laminar flow cabinet /Tissue culture hood /clean benches. • It is enclosed bench Designed to prevent contamination of microorganisms at time of biochemical testing, performing reaction,also use for sensitive materials.
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  • 16. • It consists of filter pad,a fan(blower)&a HEPA filter and 1 laminar air flow bench. • Air is passed though a HEPA filter which remove all airborne contamination to maintain sterile condition. • It also consist switch for UV light, Visible light and for motor. • It is made of SS with no gaps or joints.
  • 17. Types of Laminar Flow cabinet Horizontal Laminar air flow Vertical laminar air flow
  • 18. Working : • Firstly on the UV light about 30min to sterile the laminar flow… • Then wipe the working surface with ethanol then use it. • Then on the motor,the blower suck the air through the filter pad where dust is trapped. • After that pre filter air has to pass the HEPA filter where microbes are removed. • Sterile air flow into Working area.
  • 19. Advantages This system is portable Helps to reduce turbulence Disadvantages It is expensive UV rays are harmful to health
  • 21. Sources : • Atmosphere • Operator • Raw material • Equipment
  • 22. Atmosphere • Air is the major source of contamination as it contains dust particles, microbes,spores etc… • It may reduced by chemical disinfection,UV light, filteration and gaseous agent and also by airlocked doors.
  • 23. Operator • The skin, hair and clothing of the operator are potent source of microbial contamination. • Operator do any manual contamination,may be due to lack of training or focus.
  • 24. Raw material • It a cone for a high proportion of microbial contamination into pharmaceutical products (water is the major source) • It may be due to improper sampling inadequate storage condition
  • 25. Equipment • The equipments and utensils used in a processing, holding, transferring and packaging are also common source of contamination of aseptic area. • It is due to improper design materials lead to corrosion improper cleaning lack of sterilization etc…
  • 26. THANK YOU ❤️ If you want to shine like a sun, first burn like a sun.