Main Steps of Cleanroom Differential Pressure Control

A cleanroom refers to a space with good airtightness in which air cleanliness, temperature, humidity, pressure, noise, and other parameters are controlled as needed.

For cleanroom, maintaining the appropriate cleanliness level is critical and necessary for cleanroom-related production activities.

Generally speaking the design, construction, and operation of a cleanroom should minimize the interference and impact of the surrounding environment on the internal space of the cleanroom, and pressure difference control is the most important and most effective way to maintain the cleanroom cleanliness level, reduce external contamination, and prevent cross-contamination.

The purpose of controlling the pressure difference in the cleanroom is to ensure that when the cleanroom is working normally or the balance is temporarily damaged, the air can flow from the area with high cleanliness to the area with low cleanliness so that the cleanliness of the clean room will not be interferenced by the polluted air.

The clean room differential pressure control is an important link in the design of the air conditioning system of the clean workshop of the pharmaceutical factory, and an important measure to ensure the cleanliness of the clean area.

The cleanroom pressure difference control chapter of “Cleanroom Design Specification” GB50073-2013 (hereafter referred to as “cleanroom specification”) includes five items, all of which are for cleanroom pressure difference control.

Article 16 of the “Good Manufacturing Practice for Drugs” (revised in 2010) requires the clean area should have a device indicating the pressure difference.

The cleanroom differential pressure control is divided into three steps:

1. Determine the pressure difference of each cleanroom in the clean area;

2. Calculate the differential pressure air volume of each cleanroom in the clean area to maintain the differential pressure;

3. Take technical measures to ensure the air volume for differential pressure and maintain the constant differential pressure in the cleanroom.