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What performance requirements do negative pressure weighing rooms need to meet for operation?

The negative pressure weighing room, as a key equipment in industries such as pharmaceuticals, biotechnology, healthcare, and electronics, consists of core components such as a cover, fan, static pressure box, balancing film, touch screen, lighting lamp, air supply box, PAO detection port, and differential pressure sensor. In the weighing process of drugs and semi-finished products, especially in the pharmaceutical industry, negative pressure weighing rooms, with their unique design, significantly improve production hygiene standards, effectively reduce the risk of cross contamination, and become an important barrier to ensure product quality and safety.

To ensure that the operational performance of the negative pressure weighing room meets the requirements of pharmaceutical production, comprehensive testing of various functions is required through equipment no-load operation to verify whether the status and performance indicators of each component meet the standards. Taking the performance verification of the negative pressure weighing hood in the aerosol workshop as an example, the core objective is to confirm whether the equipment can meet the requirements of the D-level zone under normal operation. The specific verification content is as follows:
1、 Verification cycle planning
When potential quality issues are detected in the system during routine testing, the revalidation process must be immediately initiated.
According to the validation master plan formulated by the enterprise, regular re validation work is carried out to ensure the long-term stable operation of the equipment.
2、 Verify authoritative basis
Pharmacopoeia of the People's Republic of China 2015 edition
Good Manufacturing Practice for Drugs (2010 Edition)
3、 Operational Confirmation Rules
(1) Computer system verification: Security confirmation: If the system is unable to set user permissions and passwords due to its own defects, it is necessary to check whether there are written records and other physical isolation measures to ensure data security.
(2) Control/operation confirmation: When the external power supply and operating parameters are normal, manually click the operation button to control. Each unit of the system needs to immediately respond to the start and stop of the fan, adjust the lighting switch and operating frequency, and smoothly enter the normal operating state.
(3) Display accuracy confirmation: After the equipment is running, check whether the filter pressure difference display meets the standards, whether the fan direction is consistent with the interface diagram, and at the same time, check the consistency of operating parameters such as temperature and humidity with the preset values.
(4) Data integrity confirmation: During operation, manually disconnect the power supply, observe the PLC system and overall operating status, and after restoring the power supply, ensure that the program and parameters are not lost.
4、 Equipment performance verification
Confirmation of Document Applicability: Carefully review the relevant operation, maintenance, and cleanliness inspection documents, and verify their applicability through actual operation.
Wind speed confirmation: Use an anemometer to evenly select 5 points 30cm below the filter, and measure the wind speed within the range of 0.36-0.54m/s.
Leak detection: ATI high-efficiency filter leak detection method is used to detect each filter, and the leakage rate of the filter and frame must be less than 0.01%. At the same time, a gas detector is used to ensure that the airflow path is leak free.
Illumination confirmation: Conduct comprehensive illumination testing on the work area to ensure that the overall illumination is greater than 360Lx.
Noise confirmation: After opening the weighing hood, use a sound level meter to measure the noise level at two evenly distributed testing points, which should be below 75dB.
Airflow organization confirmation: Run the weighing hood, use a smoking pen to observe the smoke flow line, and combine it with an infrared thermal imager to ensure that the airflow is unidirectional and there is no backflow phenomenon.

Self purification time confirmation: After running for 15 minutes, test the indoor particle concentration using a particle counter or observe the settling time to confirm that the self purification time is less than 20 minutes.
Cleanliness confirmation: Referring to the C+A-level air supply standard in GMP, sampling points should be reasonably arranged at a distance of 0.8 meters from the ground based on the air outlet surface area to ensure static compliance with A-level cleanliness standards.
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