aseptic area

1. Guru Nanak Institute of Pharmaceutical Science and Technology
Presented by-
Jinia Rina Ghosh(18601919065)
gnbp2019jrg.065@gmail.com
Palash Ghosal(18601919066)
gnb2019pg.066@gmail.com
B. Pharm., 3rd Semester, Section B
DESIGNING OF ASEPTIC AREA

2. CONTENTS
 Introduction
 Flow diagram of aseptic area
 Clean-up area
 Compounding section
 Aseptic filling area
 Quarantine section
 Packing and labelling section
 Construction of aseptic room
 Personnel and protective clothing
 Cleaning and disinfection
 Conclusion
 Reference

3. INTRODUCTION
 What is aseptic condition?
• Aseptic means something has been made contamination-free, that it will not reproduce or create any
kind of harmful living microorganisms.
• A condition with no microorganisms.
 What is aseptic area?
• Area which is kept contamination-free.
• Production of sterile products is executed using different aseptic techniques.
• Limit for the environmental quality of microbial and dust particle contamination.
 Production area is divided into:
1. The clean-up area
2. The compounding area
3. The aseptic filling area
4. The quarantine area
5. The packaging and labelling area
Fig: Aseptic area
[1]

4. FLOW DIAGRAM OF ASEPTIC AREA
[1]

5.  Walls and ceilings are made up of
film coating material.
 High efficiency (95%) air filter
are present.
 Air inside the clean area should
be free from dust and
microorganisms.
 Air replacements are done
frequently(10-15 air change per
hour).
CLEAN-UP AREA
Fig: Clean-up area
[1,2]

6.  Actual compounding takes place.
 Contains stainless steel cabinets
and counters and is involved in the
actual compounding.
 Maintenance of sterile conditions
is not essential, but necessary
measures should be adopted to
avoid contamination.
COMPOUNDING SECTION
Fig: Compounding area
[1,2]

7.  Control measure should be taken to
avoid contamination.
 Stainless steel counter and cabinet
should not accumulate dust.
 Mixing and the storage of the
compounded preparation should be
done outside the aseptic area.
 Compounded preparation is transferred
to this area and filling takes place.
 Strict control measures is adopted to
avoid contamination.
ASEPTIC FILLING AREA
Fig: Aseptic filling area
[1,2]

8.  Process batches as well as
approved batches are stored
separately.
 Limited access.
 under the control of a responsible
person.
 Without the consent of the in
charge, other personnel cannot
enter.
QUARANTINE SECTION
Fig: Quarantine section
[1,2]

9.  Here, batches are packed and
labelled.
 Packing is carried out by packaging
machines, while labels by over
printing devices.
 At a time, only one product labels are
printed.
 Parenteral packing plays a vital role.
 Sterility of the product is maintained.
PACKING AND LABELLING AREA
Fig: Packing and labelling area
[1,2]

10.  Smooth, easy to clean and disinfected.
 Flexing and non-flexing material can
be used.
 Walls are must be made of non-
inflammable material
 1% of 8-hydroxyquinolone,
pentachlorophenol, etc may be added to
the paint for anti-fungal action.
 Epoxy resin paints and polyurethane
paints are also used.
 Ceilings are sealed.
 Internal fittings are kept minimum.
CONSTRUCTION OF ASEPTIC AREA
FLOORS , WALLS AND CEILINGS
Fig: Construction of aseptic area
[3]

11.  Doors and windows should fit flush
with walls.
 Windows should be non-openable.
 All pipes passing through the walls of
the room should be sealed
 Gases should be piped from outside
the area.
 Sinks and drains must be excluded.
 Light sources are fitted with the
ceilings.
 Switches should be installed outside.
CONSTRUCTION OF AEPTIC AREA
DOORS, WINDOWS AND SERVICES
Fig: Construction of aseptic area
[3]

12.  Neat and reliable personnel.
 They should be in good health and free
from dermatological conditions.
 Trained personnel for GMP.
 The operator should wear sterile
protective clothing.
 All protective clothing must be
sterilized.
 Fresh sterile clothing should normally
be provided each time.
PERSONNEL AND PROTECTIVE CLOTHING
Fig: Protective clothing
[3]

13.  Cleaning agents are the alkaline
detergents and ionic surfactants.
 Quarternary ammonium compounds,
sodium hypochloride, ethanol and
formaldehyde solutions are used as
disinfectants.
 Cetrimide or chlorhexidine in 70%
alcohol are suitable for use as skin
disinfectants.
CLEANING AND DISINFECTION
Fig: Cleaning and disinfection in
aseptic area
[3]

14. This was the designing of aseptic area and its construction. Strict control measure
should be adopted to avoid contamination to the products. Cleaning and
sterilization should be done on a regular basis and personnel should be careful to
avoid contamination. Sterilized and protective clothing should be worn by each and
every persons. Thus, sterility can be maintained and contamination can be avoided.
CONCLUSION
[1]

15. 1. Jain NK. Pharmaceutical microbiology, 2nd edition, Vallabh Prakashan,
Delhi.2007, page no - 294-305.
2. Manivannan R. Singh, B. Patel YKK, Pharmaceutical microbiology, 1st edition,
Thakur publication Pvt limited, Lucknow,2018, page no - 216-226
3. Jennie W, Judith A R, Ian S. Pharmaceutical Practice, Churchill Livingstone,
Elsevier. 5th edition Production of sterile products,2014, page no - 371-384
REFERENCE