ASEPTIC TECHNIQUE | DESIGNING OF ASEPTIC AREA, ASEPTIC TECHNIQUE MICROBIOLOGY, MICROBIOLOGY NOTES

DESIGNING OF ASEPTIC AREA

WHAT'S ASEPTIC TECHNIQUE

why is aseptic technique important in microbiology

As we know that microorganisms are present everywhere in nature, some are good for us while others are harmful which cause disease and are called as pathogens. To protect patients from harmful microorganisms and pathogens during medical procedure and to maintain the quality of pharmaceutical products healthcare providers use aseptic technique.

WHAT ARE ASEPTIC TECHNIQUE

ASEPTIC: - Aseptic means freed from pathogenic microorganism.

ASEPTIC AREA: - The area where strict control measure should be adopted to avoid contamination of the preparation.

ASEPTIC TECHNIQUE: - Aseptic techniques refer to any method used to sterilize and maintain the sterility of an object or location, such as an operating theater or laboratory, though it may also wound care to prevent infection. OR

Aseptic technique means using practices and procedures to prevent contamination from pathogens. It involves applying the strict rules to minimize the risk of infection.

DESIGNING OF ASEPTIC AREA

BUILDING DESIGN, CONSTRUCTION AND PRODUCTION FACILITIES

Production of sterile products should be carried out in a clean environment with a limit for the environmental quality of microbial and dust particle contamination. This limit for contamination is necessary to reduce the product contamination.

THE PRODUCTION AREA IS NORMALLY DIVIDED INTO FOLLOWING AREAS

Ø THE CLEAN-UP AREA

Ø THE COMPOUNDING AREA

Ø THE ASEPTIC AREA

Ø THE QUARANTINE AREA AND

Ø THE PACKAGING AREA

LAYOUT OF PARENTRAL PREPARATION

THE CLEAN-UP ARE: -

The clean up area involve in washing of bottles, vials, ampoules and rubber closures. 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. This is ensured through high efficiency (95%) filters. Air existing in the clean area should be frequently replacing (10-15 air changes per hour).

THE COMPOUNDING AREA: -

This area contains stainless steel cabinets 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.

THE ASEPTIC AREA: -

In this area, strict control measures should be adopted to avoid contamination of the preparations. The 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.

THE QUARANTINE AREA: -

This area consists of 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 in charge, other personnel cannot enter into this particular area.

THE PACKAGING AREA: -

In this area, the batches are packed and labeled. Packing is carried out by packaging machines, while labels are obtained by over printing devices. At a time, only one product labels are printed. Parenteral packing plays a vital role in the production of sterile preparations. Packing should be carried out in such a manner that the sterility of the product is maintained.

REQUIREMENTS FOR DESIGN OF ASEPTIC AREA

(Aseptic technique steps)

SITE OF PREMISES: -

Aseptic area should be designed at a site away from stairs, lift shafts, corridors and general manufacturing area as these areas are capable of providing routes by which microorganisms may travel. Each stage of the production should be carried out in separate rooms of aseptic area. Store rooms should be adjacent to aseptic area where all sterile equipments and products can be stored.

SIZE OF PREMISES: -

Aseptic area should be constructed in such a manner that maximum number of personnel’s can work at a time. The rooms should be large and spacious by which overall effect of microorganisms can be reduced which ultimately results in minimal contamination.

FLOORS, WALLS AND CEILINGS: -

All clean surfaces including the floor, walls and ceilings must be smooth, easy to clean, disinfected and be constructed to minimize microbial and particulate contamination.

Floor: - Flexing and non-flexing types of materials are used for construction of floor.

Flexing floor materials are made up of synthetic elastromers of which most commonly used are (PVC) polyvinyl chloride. PVC flooring is easily repaired, cleaned, relatively cheap and simple.

Non-flexing floors are made of hard inorganic filler substances in a matrix material. When a concrete is used it must be adequately sealed with a material resistant to chemicals, solvents and cleaning fluids.

Generally floor should be made up of the following materials, a) Terrazzo b) Linoleum c) plastic Terrazzo: - It is a mixture of cement and marble which is mostly used as flooring material in aseptic area.

Linoleum: - Linoleum of heavy grade is best suited for flooring. It is available in the form of sheets and tiles.

Plastics: - Polyvinyl chloride of non-slip and matt-finish grade is ideally for aseptic area.The joints of sheets & tiles can be welded.

Walls: - must be made up of non-inflammable or fire resistant material e.g.: Stainless steel, glass, enameled steel etc. Generally plaster walls are easily damaged by the impact. For reduction of fungal growth, 1% of 8-hydroxyquinolone, pentachlorophenol etc may be added to the paint. Epoxy resin paints and polyurethane paints are also used to avoid cracking and peeling.

The ceilings are sealed to prevent the entry of microbial contaminants. Internal fittings such as a cupboards, drawers, shelves, and equipments must be kept to a minimum.

Aseptic technique examples

DOORS, WINDOWS AND SERVICES

Doors and windows should fit flush with the walls.

Doors: - Entrance should have double doors with an air-lock system should be well fitted by maintaining the positive pressure air flow and self closing. In this way, air entering from outside into the aseptic area can be prevented. Even sliding and swing doors can be used.Doors must be limited in number

Windows: - Large windows with transparent glass are suitable for aseptic area. These windows should remain closed & should be non openable and ventilation should be provided artificially by air filtration system. These type of windows are used to prevent heat loss from glass material.

All pipes passing through the walls of the room should be effectively sealed and should be flush fitting and easily cleaned.

Gas cylinders should be excluded and all gases should be piped from outside the area.

Sinks and drains must be excluded from the areas where aseptic procedures are performed in clean room areas.

Light sources in clean rooms are fitted with the ceilings to reduce the collection of the dust and to avoid the disturbance of the air flow pattern with in the room.

Non essential switches such as room lighting switches should be installed outside the clean area.

PERSONNEL AND PROTECTIVE CLOTHING: -

The main source of contamination of clean areas arises from skin scales which are released by the operators. Personnel selected to work on the preparation of the parenteral products must be neat and reliable. They should be in good health and free from dermatological conditions that might increase the microbial load. Operator –borne contamination can be controlled by limiting the number of operators in clean area. All personnel should be trained for good manufacturing practices and aseptic techniques.

The operator should wear sterile protective clothing including head wear, powder free rubber or plastic gloves, a non-fibre shedding facemask and footwear. All protective clothing is designed to prevent the contamination from the body. All protective clothing must be sterilized by moist heat sterilization or ethylene oxide sterilization. Fresh sterile clothing should normally be provided each time the person enters the aseptic area.

CLEANING AND DISINFECTION: -

Cleaning and disinfection procedures are used for the removal of microbial and particulate contamination. Cleaning agents are the alkaline detergents, non-ionic and ionic surfactants. Different types of disinfectants should be employed in rotation to prevent the development of resistant strains of microorganisms. Different concentration of quarternary ammonium compounds, sodium hypochloride, ethanol and formaldehyde solutions are used as disinfectants in cleaning area. Cetrimide or chlorhexidine in 70% alcohol are suitable for use as skin disinfectants.