How to design the air lock and buffer room in GMP - clean workshop design and installation

The air lock room is generally located at the entrance and exit of the clean room, which is a buffer room set up to block the airflow from the outside or the adjacent room and to control the pressure difference. In order to minimize the total amount of air required for particle transfer velocities (usually greater than 0.5m/s), all doors in a pollution-controlled space should be kept closed at all times. If a door in an area of ​​2 m2 is open, the air flow through the door, including particles, can reach about 3500 m3/h; if a door in an area of ​​2 m2 is closed, then Only 160m3/h of air escapes through the cracks in the door to prevent the entry of particles. An airlock can also: - maintain a pressure drop between two areas - provide a venue for donning/removing work clothes in and out of a graded space. The European Union 'GMP' appendix 1 'production of sterile pharmaceutical products' refers to the locker room as an air lock room, and two or more air lock rooms connected in series can be used for 'work clothes segmented dress'. -Using a small capacity design. Its air volume allows for a high air exchange rate, allowing for a quick recovery from high particle levels; thus minimizing contamination into a clean space when a door is opened. This principle has been exemplified in the EU GMP Annex I 'Manufacture of Sterile Medicinal Products': 'The last section of the dressing room shall remain static and shall have the same class as the area to which it is directed'. That is, when the door to a cleaner clean room is opened, the air contamination input from the airlock must not affect the level of air contamination in that clean room. - Provide access to materials and equipment disinfection/cleaning places (material or pharma machinery entry and exit channels, also known as material air lock room (MAL)). - Used as a positive pressure or negative pressure buffer for the control of pollutants in and out of special processes (usually referring to oral preparations or hazardous materials). The specific small material air lock chamber is also called 'transfer window', which cannot be used by personnel due to its too small size. For clean rooms above class B, a transfer window with a high-efficiency filter should be used for ventilation and ventilation. Air lock chamber pressure Air lock chamber can be divided into three types according to its pressure and airflow direction: gradient air lock chamber, positive pressure air lock chamber and negative pressure air lock chamber. Among them, gradient air lock is the most commonly used form, which is used for isolation between different clean areas, but cannot prevent the diffusion of product-containing air in high-level areas. The positive pressure air lock chamber and the negative pressure air lock chamber can be used to separate the airflow between different areas, and can effectively prevent the diffusion of product-containing air from the high-level area to the low-level area. locked. The normal differential pressure in the airlock from one air class to the next air class (through the airlock), and from the classified space to the unclassified space, shall be 10Pa. The pressure inside the airlock should be at a value between two adjacent spaces, depending on which door is opened, the pressure difference between the clean room and its airlock need not be 10Pa. The differential pressure in the airlock should be measured across the airlock rather than through each door. Therefore, when only one door of an airlock is opened, a measurable pressure drop (ie ≥10Pa) persists between the air levels. Both the positive pressure air lock room and the negative pressure air lock room are methods of using the air pressure in the air lock room to maintain positive or negative pressure, providing a practical method for the isolation of various areas. In the negative pressure air lock room, although the exhaust air volume is more than the supply air volume, it is still recommended to send more air to the area, so that the air lock room can recover from the polluted state faster. To ensure negative pressure, the operating mode of each door should keep it closed. It is recommended that the air lock room be equipped with an interlock system or a visual or audible alarm system to prevent more than one door from being opened at a time. The door in the closed state provides only a small passage area for particles, so less airflow is required to prevent particle entry.
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