Installation inspection and confirmation of dust-free clean workshop

Installation inspection and confirmation of dust-free clean pharmaceutical cleanroom

General content of clean room operation confirmation: check the documents and drawings; stand-alone trial operation; system joint trial operation; adjustment test. Clean room operation confirmation work procedures: check the as-built drawings; check the operating procedures and manuals; indoor cleaning and hygiene; remove the diffusion plate sealing film; single...

Text label: installation in clean room, leak detection in clean room

Installation inspection and confirmation in clean room

General content of clean room operation confirmation: check the documents and drawings; stand-alone trial operation; system joint trial operation; adjustment test. Clean room operation confirmation work procedures: check the as-built drawings; check the operating procedures and manuals; indoor cleaning and hygiene; remove the diffuser plate sealing film; ; Adjust the static pressure of each chamber; high-efficiency filter leak detection; joint trial operation of the automatic control system; seal the diffusion plate again; other related work and adjustments.

Operation procedures for inspection and operation of dust-free workshops:

Each system or equipment should have a clear and complete set of operating procedures or manuals. At least include: Relevant matters needing attention; acceptable range of key parameters; corrective measures in case of abnormal operation; indicating the operating condition of the instrument;

Necessary electrical drawings.

Confirmation of single-unit trial operation: The single-unit trial operation includes the trial operation of fans, refrigeration equipment, air conditioners, cooling water pumps, cooling towers, chilled water pumps, surface heat exchangers, and purification equipment. Each test run file should be checked for confirmation.

Trial operation of the water pump: The continuous operation should not be less than 2h under the design load, and pay attention to whether the power cord is reversely connected. The maximum temperature of sliding bearings shall not exceed 70°C, and the maximum temperature of rolling bearings shall not exceed 75°C. There is no obvious water leakage at the seal (3~20 drops/min).

Fan test run: The fan runs for not less than 2 hours at rated speed, pay attention to whether the power cord is reversed. The maximum temperature of sliding bearings shall not exceed 70°C, and the maximum temperature of rolling bearings shall not exceed 80°C.

Combined air conditioner trial operation: measured data such as air volume, resistance, humidity, heat exchange of heat exchanger, etc. Qu003d0.24yL(t2-t1)×1.163W, where Q represents the heat exchange, W; L represents the air volume passing through the heat exchanger, m3/h; y represents the air bulk density, kg/m3; t1, t2 represent respectively Average air temperature before and after the heat exchanger, °C.

Trial operation of cooling tower: water commissioning should be carried out. Trial operation of chillers and air conditioners: there should be leakage or other test results.

Confirmation of system joint trial operation: After the single machine has passed the trial operation, the normal joint trial operation of the system with a cold (heat) source must be carried out, not less than 8 hours, and there is no abnormality. After it is confirmed that the joint trial operation is normal, the adjustment test shall be carried out and its contents and results shall be confirmed.

To confirm the content and results of the adjustment test, the first step is to check the adjustment test report of the construction department. The report should include the following content as much as possible:

Detection of fan revolutions, air volume and outlet static pressure; measurement and balance of air volume in each room and each branch system; detection and adjustment of indoor static pressure; leak detection of high-efficiency filters, such as installation confirmation If the item is selected, it can be randomly tested when the operation is confirmed; the automatic control and adjustment system works together, precise setting and adjustment, temperature and humidity setting and adjustment; indoor cleanliness level. If there are working condition switching, interlocking function or pressure adjustment function, various working condition switching adjustments should be carried out.

High-efficiency filter leak detection: 1. 'Clean Room Construction and Acceptance Specifications' put forward the requirements for on-site leak detection of all air outlets for biological clean rooms. Therefore, after the air supply outlet of the ordinary high-efficiency filter in the clean room is installed, the frame and filter element should be scanned and leaked for all the air outlets to confirm that there is no leakage, or to check if there is no leakage after plugging. 2. Zero leakage exhaust air high-efficiency filter air outlet (3) Before installation, each high-efficiency filter should be scanned for leaks on site, and installed after confirming that there is no leakage. After the air outlet of the non-zero leakage exhaust high-efficiency filter is installed, the frame and filter element should be scanned for leaks. The air outlet of the biosafety pharma machinery should be implemented in accordance with relevant standards. After installation, the frame and filter element should be scanned for leaks and leaks should be scanned online.

Scanning leak detection methods include photometric method and optical particle counter method. Some industries discourage the use of DOP for filter testing for security reasons. Some industries discourage the use of oil-based aerosols for filter testing due to concerns about organic outgassing.

Photometer method is suitable for leak detection of high-efficiency filters with penetration rate ≥ 0.00005, and leak detection aerosol injection points can be set on the upstream system of the filter. Zhongjing Global Purification can provide supporting services such as consultation, planning, design, construction, installation and transformation of clean workshops and dust-free workshops.

Particle counter leak detection is suitable for all levels of clean places, especially on-site leak detection. The maximum penetration rate of the applicable filter is as low as 0.0000005% or lower, and the method is simple. Fill in the project acceptance form: At the end of the operation confirmation, the completion acceptance form of the project should be filled out.

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