Designing Aseptic area Microbiology Unit 4 Laminar Air flow HEPA filter

1. Jokahra Latghat-Azamgarh
TOPIC – Pharmaceutical Microbiology Unit 4
Designing of aseptic area, Laminar Flow equipment, Study of
difference of contamination in an aseptic area and Method of
prevention Clean area classification
Presented by - Praveen Yadav
B. Pharma 2nd Year (3rd Semester)
PT. NAGINA COLLEGE OF PHARMACY

2. Designing of aseptic area:-
An aseptic area is a room within a clean area designed, constructed,
serviced and used with the intension of preventing microbial
contamination of the products.
Aseptic technique area used to prevent the access of microbial and
particulate contamination into ophthalmic and parental products.

3. A
B
C
D
Background area of Grade A processes.
e.g.- aseptic preparation.
Preparation of sterile solution to filtered.
Handling of components after washing
The local zone for high risk operations. e.g.-
filling and making aseptic transfer
The aseptic area is divided into four main grades

4. 01
02
03
04
In aseptic area, all doors should be air
locked.
Aseptic area should as possible from
normal areas to avoid unrelated persons.
All surfaces, walls, roofs should be smooth,
unbroken, free from any cracks to minimize
the deposition of microbial.
Sliding doors not but Swing door allowed,
should be open in flow direction (+)ve to
(-)ve air pressure (+ve in room).
06
07
08
05
Two doors can not be opened
simultaneously.
A filtered air supply should be used to
maintain a positive air pressure relative
to surroundings.
HEPA (High Efficiency Particulate Air)
filter should be installed to filter the air
Then which is supply to the aseptic
rooms, pore sixe 0.2 microns.
Factors for designing of aseptic area

5. 01
Also known as laminar air flow / laminar flow
cabinet/ Tissue culture hood/ Clean Benches.
03
It consist of a filter pad, a fan and a HEPA
filter, and one laminar air flow bench.
0
4
It also consist switch for UV light,
visible light and for motor.
05
It is made up of stainless
steal with no gaps or joints.
0
6
It is used for sterilization pharmaceutical
product and equipment.
0
2
Laminar flow cabinet is an enclosed bench designed
to prevent contamination of micro-organism
Laminar flow equipment's:-

6. Before starting work on laminar flow on UV light for about 30 min to sterile the
laminar flow.
Air is passes through a HEPA filter which remove all airborne contamination to
maintain sterile condition.
Working:-
Attention:-
During UV light sterilization, stay away from laminar flow or UV light, because it
cause cancer.
Then wiped the working surface with ethanol then use it.
Then on motor, the blower suck the air through the filter pad, where dust is trapped.
After that the prefilter air has to pass the HEPA filter where contamination micro-
organism are removed.
Sterile air flow into working area.

7. Horizontal laminar air flow:-
In this, air flow from back to front.
Blower is fitted downward and
HEPA filter on front.
1. Horizontal laminar air flow
2. Vertical laminar air flow
Types of laminar flow cabinet :-
1.

8. Vertical laminar air flow:-
2.
In this, air flow from top to downward.
Blower is fitted upward of working area
with HEPA filter.

9. Source of contamination & their prevention :-
1. Atmosphere:-
1. Atmosphere 2. Operator 3. Raw material 4. Equipment
2. Operator:-
The skin, hair and clothing of the operator are
potent source of microbial contamination.
It may be reduced by that operator is in proper
uniform of aseptic area with fully cover body
and operator may be skilled.
Air is main source of contamination as it
contain dust particles, microbes, spores etc.
It may be reduced by chemical disinfection, UV light,
filtration and gaseous agent and also by air locked doors

10. 3. Raw material:-
It account for a high proportion of microbial
contamination into pharmaceutical product.
It may reduced by heat treatment, filtration and
other sterilization process in raw material.
4. Equipment:-
The equipment and utensils used in processing, holding, transferring
and packing are also common source of contamination of aseptic area.
It may be reduced by the sterilized or disinfected by heat, gaseous agents
or chemical or by autoclave.

11. THANK YOU