Confirmation of clean environment system in pharmaceutical purification workshop

Confirmation of clean environment system in pharmaceutical purification workshop

The confirmation of the clean environment system in the pharmaceutical purification pharmaceutical cleanroom is mainly the performance confirmation. In order to prove that the air-conditioning system can operate effectively and stably (with good reproducibility) in accordance with the corresponding technical requirements and can continuously maintain the clean environment in the clean room, the clean environment needs to be verified. Static testing and dynamic testing...

Text label: pharmaceutical purification workshop, purification pharmaceutical cleanroom clean environment, clean environment system confirmation

Pharmaceutical purification workshop clean environment system confirmation

The confirmation of the clean environment system in the pharmaceutical purification pharmaceutical cleanroom is mainly the performance confirmation. In order to prove that the air-conditioning system can operate effectively and stably (with good reproducibility) in accordance with the corresponding technical requirements and can continuously maintain the clean environment in the clean room, the clean environment needs to be verified. Static testing and dynamic testing.

Static means that all production equipment is installed, but there is no production activity and no operator is present. During the static test, all production and auxiliary equipment in the clean area shall not be turned on, except for the equipment that is interlocked with the air-conditioning system. During static testing, there should be no more than two testers in the same room.

Dynamic refers to the state in which the production equipment runs according to the predetermined process mode and has a specified number of operators operating on site. 'The production equipment operates according to the predetermined process mode' can be understood as the process equipment is conducting trial production or simulating production activities according to the predetermined process parameters. Therefore, in this process, all production and auxiliary equipment in other clean areas should be turned on, except for the equipment that cannot be turned on with special requirements. Pharmaceutical companies should make regulations on the number of operators allowed in each room in the clean area based on the characteristics of the production process and actual control requirements. During the dynamic test process, the number of people in each room should be actually controlled according to this requirement, and the corresponding number of personnel should be controlled. Record.

During the performance confirmation process, three consecutive static tests and three consecutive dynamic tests will be carried out. The test items include: room pressure difference test, ambient temperature and humidity test, suspended particle number test, planktonic microorganism test, sedimentation microorganism test and surface microbial testing. During execution, one test is completed for all test items every day. Zhongjing Global Purification can provide supporting services such as consultation, planning, design, construction, installation and transformation of dust-free workshops, purification workshops, sterile workshops, and clean rooms.

(1) Confirmation of suspended particle concentration

The pharmaceutical industry should confirm the concentration of suspended particles in the clean room according to the provisions of GMP and related standard guidelines, and the following provisions should be made before the suspended particle test:

1. Requirements for testers (training, quantity);

2. Requirements for testing instruments (accuracy, calibration, etc.);

3. Requirements for sampling points;

4. Requirements for sampling volume;

5. Requirements for sampling times;

6. Calculation of test results

The instruments used for monitoring airborne particles in clean areas are mostly light scattering particle counters and laser particle counters.

(2) Microbial confirmation

The environment of the clean room should avoid the breeding of microorganisms, and the corresponding cleanliness level has certain requirements for microorganisms. The pre-test regulations are the same as for suspended particles.

Monitoring methods include sedimentation bacteria method, quantitative air planktonic bacteria sampling method and surface sampling method (such as cotton swab method and contact butterfly method). When the petri dish is used for detection, in order to avoid the influence caused by the transportation or moving of the petri dish, a negative control test should be carried out at the same time. Negative control dishes are subjected to the same operation as the sampled dishes, but do not need to be exposed to sampling, and then placed in the incubator together with the sampled dishes (TSA or SDA), and the result should be no colony growth.

1. Planktonic bacteria are often monitored by a slit sampler in the impact method or a screen impact-type sampler for monitoring planktonic bacteria. Air is drawn through the porous cover, while the microorganisms in the airflow are impacted and attached to a standard petri dish for agar culture. base surface. In the production process, the sampler can be set to monitor the whole production process by using the interval method of sampling, waiting and re-sampling. In addition, the planktonic bacteria sampler also has sampling methods such as sieve impact type, surface vacuum sampling, centrifugal type, filter type and liquid impact type.

2. Sedimentation bacteria collect the live biological particles falling in the petri dish by exposure method, and then count them after culturing and multiplying. The petri dishes for sedimentation bacteria should be arranged in a representative place and a place with little airflow disturbance. The specific sampling method and culture method are: after placing the culture dish at a position close to the operating height, open the outer cover and place it upside down to expose the surface of the culture medium.

3. Surface bacteria The surface microbe test can determine the degree of contamination by microbes on the surface of objects (including work clothes). Under normal circumstances, three methods can be used: cotton swabs for indirect sampling and post-cultivation, direct contact sampling and surface rinsing. When using the direct contact method, the contact dish used should be placed at room temperature before use.

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