Aseptic pharmaceutical manufacturing is most commonly used for most vaccines, biologics, other injectable drugs, cancer drugs, ear drops, nasal sprays, and eye drops. Also known as fill-finish manufacturing, aseptic manufacturing minimizes the risk of introducing bacteria and contaminants into the body while administering medication. Aseptic processing of pharmaceuticals involves virtually every step of the manufacturing process, from the formulation to the filling, inspection, labeling, and packaging. Skilled manufacturing partners are needed for aseptic manufacturing, as errors can cause production delays, health risks, and product loss. Current Good Manufacturing Process (cGMP) standards from the FDA stipulate that aseptic pharmaceutical manufacturers must: • Have a separate, classified clean area • Ensure that air is filtered and properly circulated • Sterilize and maintain all containers and closures • Have personnel that are dressed in sterile clothes, adequately trained, and closely monitored • Set time limits for different steps of the manufacturing process • Simulate and record the manufacturing process

1. Presented By:-
MANU SINGHAI
(B.PHARM- IIIrd Sem.)
(Enrol No.-0137PY151023)
Lakshmi Narain College of Pharmacy,
Bhopal
DESIGN OF AN ASEPTIC AREA
AND
CLEAN AREA CLASSIFICATION

3. Aseptic Processing - Overview
 Certain pharmaceutical products must be sterile
 injections, ophthalmic preparations,
irrigations solutions, haemodialysis solutions
 Two categories of sterile products
 those that can be sterilized in final container
(terminally sterilized)
 those that cannot be terminally sterilized and
must be aseptically prepared

4. Aseptic Processing - Overview
Objective
 To review specific issues relating to the manufacture of
aseptically prepared products:
 Manufacturing environment
 Clean areas
 Personnel
 Preparation and filtration of solutions
 Pre-filtration bioburden
 Filter integrity/validation
 Equipment/container preparation and sterilization
 Filling Process
 Validation of aseptic processes
 Specific issues relating to Isolators, BFS and Bulk

5. Why is aseptic Technique important ?

7. Aseptic Technique
-A technique which aims to prevent pathogenic microorganisms from
being introduced to susceptible sites by hands, surfaces and/or
equipment.
There are three types of Aseptic Technique:
•Sterile Technique
•Surgical Aseptic Technique
•Standard Aseptic Technique

8. DESIGNING OF
AN ASEPTIC AREA

9. How to maintain an Aseptic area ?
-Strict control measures should be adopted to avoid contamination
of the preparations.
-Stainless steel counters and cabinets should be such that they
should not allow dirt particles to accumulate.
-Mixing and storage of the compounded preparations should be
done outside the aseptic area.
-The compounded preparations are then transferred to the aseptic
area through pipelines where the filling operation is carried out.

10. SOURCES OF CONTAMINATION
Water
Raw materials
Packing materials
Equipments
Personnel
Manufacturing process
Building and facilities
Atmospheric conditions

11. S.No Sources of
contamination
Microbes which may
be present
Measures to reduce or
control contamination
1) Water
(distil water, water for
injection, etc.)
E.coli,
pseudomonas,
clostridium , etc.
•Treatment with UV-
radiations.
•Storing at elevated temp.
2) Raw materials
(Excipients, active
p’ceutical ingredients)
Bacteria,
Fungi, bacillus, etc.
•Heat treatment for heat
labile products.
•Irradiation/ filteration
3) Packaging materials
(glass, plastic, metals)
Micrococcus, bacillus,
clodoscrium, etc.
•Moist heat sterilization.
•Chemical/ radiation
treatment
4) Atmosphere
(dust, droplets, free
microbes)
Sarcina, bacillus,
mycobacterium, etc.
•Filteration by HEPA filter.
•Removal of air-borne dust
settled on walls, floors &
ceilings.
5) Personnel
(manufacturer,
employees, workers)
Bacillus,
Staphylococcus aureus
•Adequate gowning &
protective environment.
•Cleanliness & hygiene.
•Good training & personal
skills
SOURCES OF CONTAMINATION

12. AREAS TO BE ASEPTICALLY STERILISED TO
AVOID CONTAMINATION
1)SITE:- ATTEMPTS :
• To succeed if staff able to work undisturbed .
• Appropriate education should be given to everyone regularly.
• Non-p’ceutical room should be far from asepsis laboratory.
• Asepsis rooms are to be far from stairs, lifts and corridors, by
which air-borne micro-organisms can travel about the building.
• The storage of essential equipments should be near by to the asepsis area.
2)SIZE:-
•Depends upon the number of workers present or working in a particular area.
(as if area will be larger which leads to less local disturbances by an individual
workers).
•The economy, controlling & cleaning equipments can be less required, if the size is
small.
•Cleaning the upper walls & ceilings, often made easier if it is or nearer to the worker.

13. 3) WINDOWS :- (As, bright sunlight is the best detector of dust.)
• Daylight can be provided by the areas of glass bricks.
• They are not easily broken and not possible to see through them.
• Much acceptable by staff, but they must not open, as ventilation should be provided
by air-filters.
• The inner window should be a single pane & its frame must have no necessary
architraves.

14. Doors with
insulation
strip

15. 4) DOORS :-
•An air lock with double doors about 3ft apart.
•Sliding doors cause less air disturbances, but difficult to hang.
•Swing doors generally fit better, if they surrounded by insulation strip.
•A wall hatch b/w store & laboratory, using for transferring equipments.
DOUBLE DOOR
WALL
HATCH

16. 5)SURFACING MATERIALS :-
(i)Floors:- for floor most suitable-
a)Terrazzo (a mixture of cement & crushed marbles).
•It is spread in plastic form on the site or is obtainable as tiles.
•Use of PVC lead to prevent the cracking.
•Making concave sweep with plastic material/ by using concave tiles.
•The floor should gently sloped towards a gulley at one side of the room.
GULLEY
WALL WITH GULLEY FOR WATER PESSAGE TERRAZZO

17. b) Linoleum (mix. of linseed oil with gums, used as floor covering).
•It is inexpensive, reasonably warm, comfortable, quite obtainable in many
colours.
•This type linoleum is used due to less dust trapping tendency and
smoothness.
•The slippery surface gives easy cleaning and occasional oiling & also frequent
damp mopping.

18. c) PLASTICS
•The non-slip/ matt-finish grades of PVC (metallic sheet) are suitable for
asepsis room.
•These are obtained as sheet/ tiles & joints can be welded.
•Floor can be flooded with cleaning fluids without any danger of seepage
beneath.
•It is less comfortable then linoleum. Because it is thinner.
MATT-FINISH
GRADES OF
PVC

19. (ii)Walls and ceilings :- (WHAT SHOULD BE USED)
(a) TILES : It provide very smooth, non-absorbant & easily cleaned surface.
• A Advan .-Good quality seem to more satisfactory and utilitarian.
• A Dis-advan.- older types cracked / cement holding brake away to leave dust
holding space.
(b) HARD GLOSS PAINTS & SMOOTH PLASTER
• These are inexpensive & quite satisfactory when new, but must be renewed as soon
as cracking begins.
Ex.-if banged with trolleys, & therefore it is preferable to have tiles/ tarrazzo to half-
height.
(c) PLASTIC LAMINATE BOARD
• Used for covering the walls & ceilings.(but have high cost)
• Resistance to reagent (except phenol & derivatives) is excellent & dyes used can be
easily cleaned.

20. (iii) Bench tops:- (Virtually indestructible)
(a) STAINLESS STEEL:
• Solution of iodine is only used in aseptic technique.
• The attaching screw should be under the bench, not along its edge where
they are conspicuous and dirt-collecting.
(b) PLASTIC LAMINATES: (these are bright colouring & lower cost then stainless
steel)
• Plastics show bright appearance, less noisy & not as cold.
• Good heat resistance.
• Resistance to reagents (specially phenol & its solution).
• Dyes causing staining is easily removed if treatment is not delayed.
• No joints should be their, so that less affected by dust.

21. 6) SERVICES
S.No. SERVICES PURPOSE OF THESE SERVICES
1) VENTILATION •For removal of micro-organisms, control of humidity &
temp.
•Intake of fresh air.
2) ELECTRICITY •For lightning
•For a hot plate, UV-lamp, aerosol producer/ vacuum
pump.
3) GAS For Bunsen burner
4) COMPRESSED
AIR/ VACCUMS
For clarification & bacterial filtration.
5) WATER Not necessary/ imp. For laboratory, but for washing
purposes.
6) A METHOD OF
DEALING WITH
WASTE
To facilitate dust control, pipes should be hidden either in
wall/ fixed bench be used.

22. 1) ELECTRICITY
• Strip lightning is the most pleasant to work in.
• Flush glass/ plastic panels to be used in a false ceiling.
• Wires/ pipes should be hidden either in wall/but plastic.
• Switches & sockets should be of plastic, as metal are less resistant.
• Finger plates should be of plastic other than metal.
• Controls should be outside the room.

23. 2) GAS:
• Gas cocks may be on the wall or at the back of the bench, but controls must be
easy to reach.
• The gas cocks should be under the bench, if it is on the bench top there is a risk
of accidentally catching the latter/ fire.

24. 3) WATER
• Stands of the drinking fountain type are economical with space because at least 4-5
workers can use each at one time.
• Elbow-operated taps are arranged along tiled wall & water falls into a gulley, the
user being protect from splash by adjustable sheets of armoured glass at waist level.
• Individual pedestals with knee-operated taps are obtainable.
(In all types, no need to use cleaned hands for turning off the water. A comfortable
temp. is produced by fitting mixing valves).

25. WATER.....contd.....
• Soap is conveniently supplied ,in liquid form, to dispenses on the wall or on top of
fountain.
• Electric hand-dryer are usually slow & paper towels to be used.
• Hand washing should be done outside the room.

26. 4) WASTE DISPOSAL
• A foot operated waste-bin is popular but not so easily be used as it not possible all
the time to have the waste-bin around us and to open it & to use it.
• A better method is to fit, at the side of the knee-space, a metal ring that can be
swivelled under or out from the bench & into which can be slipped a plastic or stainless
bucket or large bowl.

28. CLEAN ROOM AREA CLASSIFICATION