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Present by- Guide by -
Aksha Y. Sheikh Prof. Puja R. Bansule
Bpharmacy 3rd sem
Gondia college of pharmacy, Chulod
Subject- Pharmaceutical microbiology
Content-
1.Introduction
2.Aseptic area
3.Fow diagram of aseptic area
4.Designing of aseptic area
5.laminar air flow equipment
6.Air supply
7.Air flow patterns
Introduction:
ASEPTIC AREA- Asepsis is practice to
reduce or eliminate contaminants
(such as bacteria, virus, fungi and
parasites)
from entering operative field in Surgery
or medicine to prevent infection.
Ideally a field is “sterile”- free of
contaminants a situation that difficult
to attain.
 This area free from any
contamination is ASEPTIC AREA.
Production of sterile products should be carried out in clean
environment with a limit for the environmental quality of microbial
and dust particle contaminants
This limit for contamination is necessary to reduce the product
contaminant.
 The production area is normally divided into
1. The clean-up area,
2. The compounding area,
3. The aseptic area,
4. The quarantine area and
5. The packaging/ labelling area.
Clean-up section
 The cleaning area has walls and ceilings
made up of film coating materials.
 Air inside the clean area should be free
from dust and microorganisms.
 The is ensured through high deficiency
(95%) filters.
Air existing in the clean area should be
frequently replace (10-15 air changes
per hour).
Compounding section
 This area contains stainless steel
cabinet and counters and is involved
in the actual compounding.
 Unlike aseptic area, maintenance of
sterile conditions is not essential, but
necessary measures should be
adopted to control the dust generated
from raw material during weighing
and compounding
Aspetic area
 In this area, strict control measures should be
adopted to avoid contamination of the
preparation.
 The stainless steel counters and cabinets
should be such that they should not allow dirt
particles to accumulate.
 Mixing and storage of the compounded
preparation should be done inside the
Aseptic area.
 The compounded preparation are then
transferred to the Aseptic area through
pipelines where the filling operations is
carried out.
Quarantine section
This area consists to a store where the in
process batches as well as approved
batches are stored separately.
 This area has limited access and is under
the control of a responsible person.
 Without the consent of the incharge, other
person cannot enter into the particular
area.
Packing and labelling section
 In this area, the batches are packed and labelled.
 Packing is carried out by packaging machines,
while labels are obtained by over printing devices.
 At a time, only one product labels are printed.
 Parental packing plays a vital role in the
production of sterile preparation.
 Packing should be carried out in such a manner
that the sterility of the product is maintained.
 Flow diagram of aseptic area
Floors, walls and ceilings
Doors, windows and services
Personal and protective clothing
Cleaning and disinfection
Air supply
Laminar air flow equipment
Vertical laminar air flow Horizontal laminar air flow
Air flow patterns
1. Unidirectional airflow
2. Non-unidirectional airflow
3. Combine airflow
Thank you!
🙃

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Designing of aseptic area and laminar flow equipment.pdf

  • 1. Present by- Guide by - Aksha Y. Sheikh Prof. Puja R. Bansule Bpharmacy 3rd sem Gondia college of pharmacy, Chulod Subject- Pharmaceutical microbiology
  • 2. Content- 1.Introduction 2.Aseptic area 3.Fow diagram of aseptic area 4.Designing of aseptic area 5.laminar air flow equipment 6.Air supply 7.Air flow patterns
  • 3. Introduction: ASEPTIC AREA- Asepsis is practice to reduce or eliminate contaminants (such as bacteria, virus, fungi and parasites) from entering operative field in Surgery or medicine to prevent infection. Ideally a field is “sterile”- free of contaminants a situation that difficult to attain.  This area free from any contamination is ASEPTIC AREA.
  • 4. Production of sterile products should be carried out in clean environment with a limit for the environmental quality of microbial and dust particle contaminants This limit for contamination is necessary to reduce the product contaminant.  The production area is normally divided into 1. The clean-up area, 2. The compounding area, 3. The aseptic area, 4. The quarantine area and 5. The packaging/ labelling area.
  • 5. Clean-up section  The cleaning area has walls and ceilings made up of film coating materials.  Air inside the clean area should be free from dust and microorganisms.  The is ensured through high deficiency (95%) filters. Air existing in the clean area should be frequently replace (10-15 air changes per hour).
  • 6. Compounding section  This area contains stainless steel cabinet and counters and is involved in the actual compounding.  Unlike aseptic area, maintenance of sterile conditions is not essential, but necessary measures should be adopted to control the dust generated from raw material during weighing and compounding
  • 7. Aspetic area  In this area, strict control measures should be adopted to avoid contamination of the preparation.  The stainless steel counters and cabinets should be such that they should not allow dirt particles to accumulate.  Mixing and storage of the compounded preparation should be done inside the Aseptic area.  The compounded preparation are then transferred to the Aseptic area through pipelines where the filling operations is carried out.
  • 8. Quarantine section This area consists to a store where the in process batches as well as approved batches are stored separately.  This area has limited access and is under the control of a responsible person.  Without the consent of the incharge, other person cannot enter into the particular area.
  • 9. Packing and labelling section  In this area, the batches are packed and labelled.  Packing is carried out by packaging machines, while labels are obtained by over printing devices.  At a time, only one product labels are printed.  Parental packing plays a vital role in the production of sterile preparation.  Packing should be carried out in such a manner that the sterility of the product is maintained.
  • 10.  Flow diagram of aseptic area
  • 11. Floors, walls and ceilings
  • 12. Doors, windows and services
  • 16. Laminar air flow equipment Vertical laminar air flow Horizontal laminar air flow
  • 17.