What Performance Requirements Must a Negative Pressure Weighing Booth Meet During Operation? – Negative Pressure Weighing Booth Manufacturer

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As critical equipment in pharmaceutical, biotechnology, medical, and electronics industries, the negative pressure weighing booth comprises components such as the enclosure, fan, static pressure box, equalizing membrane, touchscreen, lighting, air supply housing, PAO test port, and differential pressure sensors. During weighing of pharmaceutical products and semi-finished goods—especially in pharmaceutical manufacturing—its unique design significantly enhances hygiene standards, effectively reduces cross-contamination risks, and serves as a vital barrier for product quality and safety.

To ensure operational performance meets pharmaceutical production requirements, comprehensive functional testing under no-load conditions is essential to verify component status and performance indicators. Taking a negative pressure weighing booth in an aerosol workshop as an example, the core objective is to confirm whether the equipment meets Grade D area requirements under normal operation. Specific verification contents include:

I. Validation Cycle Planning

Re-validation must be initiated immediately when routine testing reveals potential system issues that could affect quality.

Periodic re-validation should be conducted according to the corporate validation master plan to ensure long-term operational stability.

II. Authoritative Validation References

• Chinese Pharmacopoeia (2015 Edition)

• Good Manufacturing Practice for Pharmaceutical Products (2010 Edition)

III. Operational Qualification (OQ) Details

(1) Computer System Validation – Security Confirmation: If the system cannot set user permissions and passwords due to inherent limitations, verify that written records and other physical isolation measures are in place to ensure data security.

(2) Control/Operation Confirmation: Under normal external power supply and operating parameters, manually activate control buttons. All system units must respond immediately to fan start/stop, lighting switching, and frequency adjustments, and transition smoothly to normal operation.

(3) Display Accuracy Confirmation: During equipment operation, verify that filter differential pressure readings meet standards, fan rotation direction matches interface indications, and operating parameters (temperature, humidity, etc.) align with preset values.

(4) Data Integrity Confirmation: Interrupt power supply during operation, observe PLC system and overall operational status, and after power restoration, confirm that programs and parameters remain intact.

IV. Equipment Performance Qualification (PQ)

Documentation Applicability Verification: Carefully review relevant operation, maintenance, and cleanliness inspection documents, and validate their applicability through actual operation.

Airflow Velocity Confirmation: Using an anemometer, measure at 5 evenly distributed points 30 cm below the filter. Air velocity must fall within 0.36–0.54 m/s.

Leak Testing: Employ the ATI HEPA filter leak test method for each filter. Leakage rates for filters and frames must be below 0.01%, and gas detectors should confirm no leakage along airflow paths.

Illuminance Confirmation: Conduct comprehensive illuminance testing of the work area, ensuring overall illuminance exceeds 360 Lux.

Noise Confirmation: With the booth operating, measure noise at two evenly distributed test points using a sound level meter; levels must remain below 75 dB.

Airflow Organization Confirmation: Operate the booth and use a smoke pen to observe airflow lines, supplemented by infrared thermal imaging, to confirm unidirectional airflow with no backflow.

Self-Cleaning Time Confirmation: After 15 minutes of operation, measure airborne particle concentration using a particle counter or observe settling time. Self-cleaning time must be less than 20 minutes.

Cleanliness Confirmation: In accordance with GMP Grade C + A supply air standards, arrange sampling points at 0.8 m height based on outlet surface area, ensuring static conditions meet Grade A cleanliness standards.

With the continuous evolution of GMP requirements, negative pressure weighing booths are increasingly widely used in pharmaceutical sampling rooms and weighing/dispensing areas. Since products are often exposed during weighing, regular validation and verification following risk control principles are essential for maintaining a sound pharmaceutical production environment. Zhongjing Purification has deep expertise in purification equipment, with extensive experience in the design, manufacturing, and validation of negative pressure weighing booths. We offer one-stop services from equipment selection to performance verification, helping companies strictly adhere to industry standards and ensure compliant, efficient production. For inquiries, please feel free to contact us.