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Confirmation, testing, monitoring and verification of clean room in pharmaceutical factory

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Pharmaceutical factory clean room


(1) Confirmation and verification of drug production enterprises

1. Confirmation of pharmaceutical production: It is a series of activities that prove plant, facilities and equipment correctly and achieve expected results.

2. Verification of pharmaceutical production: It is a series of activities that prove any operating procedures (methods), production processes or systems.

(2) The confirmation of the clean room of the pharmaceutical factory can be divided into:

1. Design confirmation: Design confirmation is to prove that the design of factory buildings, facilities and equipment meets the requirements of the predetermined use and \"Pharmaceutical production quality management specification \".

2. Installation and confirmation: Installation of the master is to prove the construction and installation of plant, facilities and equipment, meet the design standards to meet the requirements of the production process.

3. Run confirmation: Run confirmation is to prove the stability, reliable operation of the plant, facilities and equipment and meet the design standard.

4. Performance Confirmation: Performance Confirmation is to prove that the plant, facilities and equipment can continue to ensure its performance and meet the design standards under normal operation methods and normal processes.

5. Process verification: It should prove that a production process can continue to produce drugs that meet the registration requirements of the predetermined use by the process parameters.

(3)Pharmaceutical factory clean roomMonitoring of normal dynamics

1. Monitoring of the dynamics of the key operation area, the clean level A and the Class B region. The frequency of monitoring should be able to generate problems in the production process in time. Such as: artificial intervention, occasional events, and other issues. Dynamic monitoring is performed for the area of ​​the cleanliness C-class and D level.

2, dynamic monitoring temperature, relative humidity, cleanliness and pressure gradient.

3, dynamic monitoring of maximum allowable number of microorganisms, common settling method, quantitative air floating bacteria and surface sampling method.

4. It is also necessary to monitor the operation of the operator.

(4) Verifying process verification of drug production processes should prove that a production process can continue to produce drugs that meet the requirements of registration in accordance with the predetermined use of process parameters.

(5) Static inspection project of clean room

Static testing project contains:

(1) The air volume of clean room, including air supply, return air volume, new air volume, exhaust amount

(2) The static pressure difference of clean room;

(3) Cleanroom cleanliness, including particle concentration, microbial maximum permissible number;

(4) Clean room temperature and relative humidity;

(5) Illumination, noise in clean room;

(6) Cleanroom's self-cleaning time;

(7) The average wind speed of the segmentation of one-way circular clean chamber.

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