Aseptic area:

Definition:
Aseptic implies that everything has been made contamination-free, that no dangerous living microorganisms
(bacteria, viruses represent a substance that is absolutely free of all germs) .in another meaning removal of
anything that may contaminate a manufacturing environment.
Sources of aseptic-area pollution and method of prevention:
1. Construction Atmosphere Ambient
2. The Water
3. Crude Content
4. Operators of Systems
5. Facilities
6. Atmosphere Ambient
7. Packaging
Design of production facilities:
• products should be manufactured in a safe environment with a microbial and dust particles emission
environmental quality cap.
• To minimize product contamination, this contamination cap is necessary.
Floors, roofs, and walls:
 All clean surfaces must be smooth, easy to clean, disinfected, and built to reduce microbial and particulate
contamination, including the floor, walls, and ceilings.
 Flexing and non-flexing materials are used for floor construction.
 Flexing floor materials are made up of polyvinylchloride (PVC) synthetic elastomers, which are most
widely used. PVC flooring is easy to fix, clean, comparatively inexpensive, and basic.
 Non-flexing floors in a matrix material are built of hard inorganic filler substances. A substance resistant to
chemicals, solvents, and cleaning fluids must be properly sealed when concrete is used.
 Stainless steel, glass, enamel steel, etc. can consist of walls that are not flammable or fire-resistant.
In general, plaster walls are easily destroyed by the impact
 A paint to suppress fungal growth will use 1% of 8-hydroxyquinoline, pentachlorophenol, etc.
 Epoxy resin paints and polyurethane shades are also used to resist cracking and peeling.
 The ceilings are insulated to avoid the entry of microbial pollutants.
 Internal fittings must be kept to a minimum, such as cupboards, drawers, shelves, and appliances.
Windows, doors, and equipment:
 The doors and windows should fit the walls.
 Windows are mainly supplied For lighting and not for ventilation if necessary.
 Windows should be Not openable
 Doors should be well suited by maintaining the positive air pressure flow and self-closing. The number of
doors must be restricted.
 All tubes are effectively sealed and pass through the walls of the room and are suitable for flow and easy
cleaning
 Gas cylinder should be eliminated and all gasses should be piped out from outside the region.
 In the areas where aseptic operations are carried out, drain on and cesspool in cleanroom areas must be
eliminated
 The ceilings are fitted with light sources in clean rooms to decrease the accumulation of dust and to prevent
disruption of the air flow pattern in the building.
 Outside the clean area, non-essential switches should be mounted, such as room lighting switches.
 The ceilings are fitted with light sources in clean rooms to decrease the accumulation of dust and to prevent
disruption of the air flow pattern in the building.
 Outside the clean area, non-essential switches should be mounted, such as room lighting switches.
Staff and protective gear:
 The key source of clean area pollution occurs from skin scales produced by operators.
 Workers chosen to work on preparing the parenteral items must be clean and effective.
 They should be in complete health and free from conditions of dermatology that could raise the microbial
load.
 Operator-borne pollution can be regulated by restricting the number of clean-area operators.
 All workers should be trained in good production procedures and aseptic techniques.
 Sterile protective gear, including headwear, powder-free rubber or plastic gloves, a non-fiber shedding
facemask, and boots, should be worn by the operator.
 All protective clothing is designed to prevent contamination from the body
 All protective clothing must be sterilized by moist heat sterilization or ethylene oxide sterilization.
 time the individual enters the aseptic region, fresh sterile clothing should normally be given it.
Disinfection and washing:
 For the elimination of microbial and particulate contaminants, washing and disinfection methods are used.
 Alkaline detergents and non-ionic and ionic surfactants are washing agents.
 To avoid the production of resistant strains of microorganisms, different forms of disinfectants should be
used in rotation.
 Different amounts of ammonium compounds, sodium hypochlorite, ethanol, and formaldehyde solutions are
used in the cleaning area as disinfectants.
 Cetrimide or chlorhexidine are appropriate for use as skin disinfectants in 70% of alcohol.
The Supply of Air:
 Filters of high-efficiency particulate air (HEPA) shall be used to filter the air supplying to a clean space.
 To increase the final filter life, you must position the HEPA filter in the clean space inlet and the pre-filter
upstream can be installed.
 In laminar airflow bench construction, vertical and horizontal HEPA filters are used.
 99,97% are believed to be free of microbial contamination of the air filtered from the laminar airflow.
 These filters support category 100 air, and every 6 to 12 months should be approved.
 Air quality is measured with settle plates, microbial air samplers, or particle counters.
Laminar flow equipment:
 Vertical laminar air flow bench
 Horizontal laminar air flow bench
Direction of air flow in horizontal laminar air flow

Vertical laminar air flow bench

Air flow pattern :

To prevent the generation of particles from the clean floor, walls,

Airflow in one direction Airflow not one-way Airflow Combined

Pharmaceutical Guidelines- The author and pharmaceutical founder is Ankur Choudhary is- India's- since 2008
Published on Dec 8, 2017