Pharmaceutical Airlock Systems
An airlock is a small, sealed chamber that is typically used to prevent air from flowing between two areas that are at different pressures. It is also a type of door or series of doors that are designed to prevent contamination from outside air from entering a clean area. In a pharmaceutical company, an airlock system is used to prevent air from flowing between clean and dirty areas, or between areas where different levels of contamination are allowed. The pressure inside the airlock is typically different from the pressure in the surrounding areas, and this difference in pressure helps to prevent air from flowing between the different areas. In order to maintain the necessary pressure differential, the airlock system may be equipped with fans or other mechanical systems to control the flow of air. These systems are typically designed to operate automatically, and they are an important part of maintaining the cleanliness and safety of a pharmaceutical production environment.
The following factors should be considered while designing an airlock system for pharmaceuticals:
Airlocks are called PAL (Personnel Air Lock) when used for personnel and MAL (Material Air Lock) when used for transferring material.
Airlock doors should be opened to the higher-pressure side to assist in closing the door.
An interlocking system should be installed to prevent both doors from opening simultaneously.
An alarm should be supplied to notify that one door has been opened. It aids in preventing contamination from entering through the airlocks.
The airlock should have at least 20 air changes each hour. It makes it easier to remove impurities that have entered from the outside.
Airlocks should be kept empty of stuff such as clothing, shoe covers, and so on.
There are several different types of airlock systems that are commonly used in pharmaceutical companies, including:
A.?????Single-door airlock systems: These systems typically consist of a single door that leads into a clean area. In order to enter the area, the person must first pass through the door, which is sealed behind them before they can proceed.
B.?????Two-door airlock systems: These systems consist of two doors, with the first door leading into a small antechamber or vestibule. The person must first pass through this first door, which is sealed behind them before they can proceed through the second door into the clean area.
C.?????Three-door airlock systems: These systems consist of three doors, with the first two doors leading into a small antechamber or vestibule. The person must pass through the first two doors in sequence, with each door being sealed behind them before they can proceed through the third door into the clean area.
D.????Automatic airlock systems: These systems use automated doors and controls to manage the flow of people and materials into and out of the clean area. The doors are typically opened and closed using sensors or other control systems and may include additional features such as air purification systems or decontamination chambers.
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E.?????Pressure-differential airlock systems: These systems use a pressure difference between the clean area and the outside air in order to prevent contamination. In order to enter the clean area, the person must pass through a series of doors that are designed to maintain the pressure difference, with each door being sealed behind them before they can proceed to the next one.
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In general, there are three basic airlock designs that can be combined or used individually to protect the clean room and/or prevent cross-contamination between two adjacent areas of different process operations served by two different HVAC systems. These three airlocks are:
1.?????Cascade Airlock
2.?????Bubble Airlock
3.?????Sink Airlock
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1.?????Cascade Airlock:?These airlocks are very common having higher pressure on one side and lower pressure on another side. In this system, positive air pressure flows from the higher-pressure internal zone to be airlock and from the airlock to the lesser lower-pressure grade area. This prevents to entry of dust and contamination from outside to the airlock and from the airlock to the inner side.
?Application:
Any manufacturing facility where the product requires protection from particulate but the people outside the?clean room?does not need protection from the product in the clean room.
2.?????Bubble Airlock:?These types of airlocks have higher pressure inside the airlock and lower pressure on both outside. It creates a barrier where contaminants within either area are pushed back into their own respective areas.
Application:
Used in, areas where the product needs protection and the people external to the cleanrooms require protection from the product, to reduce the possibility of viable articulate from entering the lesser pressure clean-room. In areas such as higher potency, and compounding areas terminal sterilization is not an option.
3.?????Sink Airlock:?These airlocks have lower pressure inside the airlock and higher pressure on both sides of the airlock. This airlock pulls air from both adjacent areas creating a low-pressure barrier and reducing the opportunity for contaminations passing to the internal zone.
Application:
In many research facilities, substances that are experimented on are highly dangerous, and it is essential to keep them from being exposed. During a few types of production processes in a clean room, air from a contaminated area has to be contained in one place.
In conclusion, a proper URS and subject matter expertise is the need of the hour to design, qualify and operate such clean room facilities with good airlocks, In one way we would call Air Locks are ventricles of the heart. If they fail the whole system collapses.