1) An aseptic area is a sterile environment designed to prevent microbial contamination of products. It must control dust and avoid provisions for microbes to enter.
2) Laminar flow equipment uses HEPA filters to blow sterile air and prevent contamination when performing sensitive tasks. It maintains sterile conditions.
3) Sources of contamination in an aseptic area include airborne microbes, operators, raw materials, and equipment that are not properly sterilized or stored. Maintaining aseptic technique and conditions is important to prevent contamination.
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.
14.
15.
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
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.