Aseptic Area.

Introduction:

Production of sterile products is carried out in a clean area which has strictly controlled environmental quality of air particles, microbial contamination.
Some pharmaceutical products are not terminally sterilized (Packed, Sealed and Sterilized) such products are meant to be prepared from sterile ingredients and are sterilized by filtration before packing in sterile containers.
For manufacturing of such products strict aseptic measures need to be followed and hence as Aseptic Area becomes an essential part of such manufacturing units.
An aseptic area is a premise in a clean area, designed, constructed, serviced and used with an intention to prevent the microbial contamination of the product.

The sterile production unit and the general manufacturing area within the hospital pharmacy or factory should be located separately.
The sterile production unit should be restricted, i.e., unauthorised personnel should not gain access to this unit.
The aseptic unit is designed to carry out each stage of production separately. The unit should also ensure a safe and organised workflow so that the need for personnel to move around the clean rooms is minimised.
The production area for sterile products is normally divided into,

Only authorised personnel can gain access to the clean and aseptic filling areas.
The personnel enter the clean rooms by passing through the changing rooms where they put on and remove their clean room uniform.
A pass-Over (or cross-over) bench extends across the changing room to form a physical barrier for separating the different areas for changing by the personnel.
Special precautions are taken for preventing clean and aseptic filling areas from getting contaminated while materials are being passed through airlocks or hatchways.
Thus, sterilisers and entry ports are fitted with double-sided doors, which are interlocked to prevent simultaneous opening of both the doors.

The floor, wall, and ceiling surface of clean rooms should be smooth, waterproof, and unbroken to reduce the release and accumulation of contaminating particles and organisms.
The surface material should be such that they can withstand the effects of cleaning agents and disinfectants.
The ceilings are scaled so that the contaminants do not enter from the space above them.
Uncleanable small spaces should be avoided within the clean rooms to minimise the accumulation of contaminating particles.
Thus, the wall and floor junction should be covered.
Minimum shelves, ledges, cupboards, and equipment should be present.
Non opening and sealed windows should be present to prevent the entry of contaminants.

The piped liquids and gases entering the clean rooms should be filtered first, thus ensuring that the liquid or gas at the work position is as clean as the air in the clean room.

The position of pipes and ducts should be such that they can be easily cleaned.
Other fittings, like fuse boxes and switch panels should be placed outside the clean rooms.

Sinks and drains should not be present in areas where aseptic procedures are carried out within the clean room areas.

They should nowhere be present in the complete unit.
The areas having sinks and drains should be designed, positioned, and maintained such that the risk of microbial contamination is reduced; therefore, they are fitted with easily cleanable traps, installed with electrically heated disinfection devices.

A limited number of doors and ports should be present for entry of personnel and materials, respectively.

The entry doors should be self-closing to allow easy movement of the personnel.
Airlock doors, wall ports, through-the-wall autoclaves, and dry heat sterilisers should have interlocked doors to prevent simultaneous opening of both the doors.
All the doors should have an alarm system which should ring when more than one door is being opened.

Lights in clean rooms should be fitted with the ceiling so that dust accumulation reduces and also the airflow pattern within the room is not disturbed.
The equipment in clean rooms should be positioned such that accumulation of particles and microbial contaminants does not occur.