Pharmaceutical Cleanroom Pressure Difference Control Key Points

Pressure difference control in pharmaceutical cleanrooms is core for drug quality.  Loss of control easily lead to serious problems such as cross-contamination and validation failures. Room airtightness is key factor in maintaining stable pressure differences, must be considered throughout the entire process of design, construction, commissioning, and operation and maintenance.

1. Core System Characteristics

Pharmaceutical HVAC systems have stringent requirements for parameters such as temperature, humidity, and pressure difference. Design and construction must strictly match process requirements, and dynamic monitoring must be implemented.

2. Key Control Points in the Design Phase

(1). Hole Sealing Design

Selection should be based on airtightness requirements: high-requirement workshops should use through-wall sleeves, active/vaccine workshops should be equipped with airtight seals, and low-requirement areas can use decorative covers.

(2). Door, Window, and Transfer Design

Pressure-controlled rooms should use fixed double-glazed windows, and material transfer should use dedicated transfer windows; cleanroom doors must consider both structural strength and sealing performance.

(3). HVAC System Design

The smoke exhaust system should use normally closed plate-type smoke exhaust vents, and sufficient margin should be reserved for supply and exhaust air volume to cope with potential airtightness problems and ensure pressure difference adjustment redundancy.

3. Quality Control in the Construction Phase

(1). The connection of color steel sandwich panel should prioritize the use of central aluminum profiles, and high-airtightness areas require internal and external sealant;

(2). The gaps at the connection between the ceiling and wall panels must be strictly controlled;

(3). Cleanroom door sweeps should be made of wear-resistant and easy-to-maintain materials;

(4). The ground flatness deviation should be controlled within 2-3mm.

4. Commissioning and Operation and Maintenance Management Strategies

(1). Make special plan before commissioning.. First, air volume balance should be completed, and the pressure difference stability should be monitored for 24-48 hours of continuous operation. The validation phase requires simulating extreme operating conditions, and successful completion requires passing three consecutive tests.

(2). During the operation and maintenance phase, a remote monitoring and regular inspection mechanism should be established, professional equipment should be used for leak detection, and VAV valves should be calibrated regularly.

The core of differential pressure control lies in ensuring the airtightness of the entire process. This requires coordination between the building and HVAC systems, addressing potential problems from the design stage, strictly controlling construction quality, and strengthening commissioning, operation, and maintenance management to completely eliminate drug quality accidents caused by uncontrolled differential pressure.

Suzhou Pharma Machinery Co.,Ltd.

2025/12/30

Icey