SZ Pharma Focuses On Professional Cleanroom Project And Pharmaceutical Cleanroom Equipment, 100% pass GMP and cGMP
The core requirement for installing differential pressure (DP) gauges in cleanrooms is to maintain directional airflow gradients and prevent cross-contamination. Installation requirements vary significantly depending on the function and scenario.
1. Differential Pressure Monitoring Between Different Cleanliness Levels
(1). Clean Area vs. Non-Clean Area/Outdoors
Mandatory installation. Recommended at a conspicuous spot near the entrance on the non-clean side, 1.5-1.8m above the ground. The pressure difference must be ≥10Pa.
(2). Adjacent Areas of Different Cleanliness Levels
Mandatory installation. Recommended at the doorway on the lower cleanliness level side for easy observation. The adjacent gradient must be ≥5Pa, and the overall pressure difference between different levels must be ≥10Pa.
(3). Same Level: Core Aseptic Operation Room vs. Clean Corridor
Recommended on the corridor side, avoiding airflow disturbances from supply/return vents. The operation room should maintain a relative positive pressure of 5-10Pa.
(4). Same Level: Dust/Contaminant Generating Room vs. Clean Corridor
Mandatory installation. Recommended above the door frame on the corridor side to minimize vibration. The dust-generating room should maintain a relative negative pressure of 5-10Pa.
(5). Personnel Flow Channel: Primary Changing → Secondary Changing → Buffer Room
Mandatory installation. Recommended at the entrance on the lower cleanliness level side. The pressure gradient at each level must be ≥5Pa.
2. Differential Pressure Monitoring in Special Functional Cleanrooms
(1). Solid Dosage Dust-Generating Workshop
Mandatory for all dust-generating rooms facing the corridor. The gauge body should be installed on the corridor side, avoiding direct supply air. The room must maintain relative negative pressure to prevent dust from spreading to public areas.
(2). High-Sensitization / Antibiotic Workshop
Mandatory for all core and adjacent areas. Install on the external protection area side; core negative pressure zones require redundant instrumentation. The core production area must maintain a relative negative pressure of -30 to -40Pa to completely prevent the spread of sensitizing materials.
(3). Stem Cell / Biosafety Laboratory
Mandatory for negative pressure zones, adjacent areas, buffer rooms, and core areas. Recommended at a conspicuous entrance location. The negative pressure zone must maintain a difference of ≥10Pa relative to adjacent areas, with gradients decreasing stepwise from the core outward.
(4). Sterile Drug Filling Workshop
Mandatory for the core filling area and adjacent Grade B zones. Recommended at the Grade B zone doorway. The filling area must maintain a positive pressure gradient of ≥5Pa relative to adjacent areas.
(5). Ordinary Electronic Component Cleanroom
Mandatory between different levels and clean/non-clean zones; can be simplified for same-level functional rooms. Recommended on the entrance partition wall; a pressure gradient of ≥5Pa is sufficient.
3. General Installation Technical Requirements
(1). Mounting: Must be installed vertically. After installation, use the zero-adjustment knob to reset the pointer/reading to zero.
(2). Sealing: Seal unused ports with PTFE tape. Strictly follow the rule: connect high-pressure port to the high-pressure area and low-pressure port to the low-pressure area. Do not reverse.
(3). Location: Avoid supply/return vents, dead zones, and turbulence to minimize reading errors. The location must accurately reflect pressure changes between adjacent areas; do not deliberately choose a "dead spot" to mask real pressure anomalies.
(4). Range: For general cleanrooms, a 0-60Pa range is preferred. For negative pressure biosafety labs, a -50Pa to +50Pa range can be selected.
(5). Type: Mechanical DP gauges are preferred for compliant production workshops due to better stability and anti-interference. Digital transmitters can be paired in key areas for remote monitoring.
Suzhou Pharma Machinery Co.,Ltd.
2026/07/01
Icey
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