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Home / Blog / Operation And Maintenance of Class C Bioengineering Cleanroom

Operation And Maintenance of Class C Bioengineering Cleanroom

Views: 0     Author: Site Editor     Publish Time: 2025-03-07      Origin: Site

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Definition

Class C bioengineering Cleanroom is a clean level in the field of bioengineering based on air cleanliness, air pressure, air volume, temperature and humidity, noise, microbial content and other indicators. It is mainly used for clean operation areas of lower importance in the process of producing sterile drugs, such as the preliminary processing of cell culture, genetic testing and other links.

Standard

  • Air Cleanliness: Class C Cleanrooms, also known as Class 10000 Cleanrooms, have a relatively low level of cleanliness, allowing up to 352,000 (static) or 3,520,000 (dynamic) particles greater than or equal to 0.5 μm per cubic meter of air.

  • Temperature and humidity control: Constant temperature and humidity need to be maintained to meet the specific requirements of bioengineering experiments or production.

  • Microbiological control: Effective measures are taken to control the growth and spread of microorganisms to ensure the sterility of the production environment.

Operation and Maintenance

  • Daily operation management

Formulate strict operation management system and operation procedures to ensure the normal operation of all equipment and facilities in the workshop.
Regularly clean and disinfect the workshop to keep the environment clean and hygienic.

  • Equipment maintenance

Establish a sound system of equipment maintenance, regular inspection, maintenance and repair of equipment.

Timely detection and elimination of equipment failure hidden danger, to ensure that the equipment is in good operating condition.

  • Personnel management

Strictly control the number of personnel entering and leaving the workshop and identity authentication to ensure that only trained and authorized personnel can enter.

Staff need to wear protective clothing and protective gear that meets the requirements to minimize the pollution of the production environment.


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