Maintenance And Management Of Class 100 Cleanroom

Cleanrooms (purification workshop) are rooms where the concentration of airborne particles is controlled. Parameters such as temperature, humidity, and pressure must be controlled. Their cleanliness level is distinguished by the number of particles of a certain diameter per unit volume of air. A Class 100 cleanroom refers to a room where the number of dust particles larger than 5μg per cubic meter of air does not exceed 100, and the average colony count does not exceed 5, and the average number of bacterial colonies does not exceed 5. Currently, cleanrooms are widely used in pharmaceutical engineering, organ transplantation, operating rooms, and other fields. To ensure the proper functioning of the cleanroom and to guarantee the quality of microbiological testing for medical devices, management must be strengthened in three aspects: environmental monitoring, operation, and personnel.

1. Environmental Monitoring and Management The sterile environment of a Class 100 cleanroom is maintained through air filtration, laminar flow, and positive pressure. Core management includes three aspects: First, controlling temperature and humidity, maintaining a temperature of 22℃～25℃ and humidity of 50%～60%, balancing human comfort with inhibiting microbial growth; second, strengthening hygiene and cleaning, wiping cabinets and floors daily with disinfectant, thoroughly cleaning weekly, and performing a major cleaning monthly; cleaning tools should not use fibrous materials, and regularly testing air particle counts and noise levels, followed by 30 minutes of ultraviolet disinfection after each operation; third, conducting regular microbial testing weekly, and developing maintenance procedures based on the results.

2. Operation Management The key tasks are as follows:

First, arrange items rationally to reduce the number of items and the frequency of entry and exit, facilitating operation.

Second, establish strict work processes and clearly define the division between clean and contaminated areas.

Third, strictly control cleaning quality; the air conditioning system must run continuously for 24 hours before initial use, and can only be used after two successful bacterial cultures. Turn on the air conditioning 30 minutes before each entry, conduct regular inspections and maintenance, replace the pre-filter and medium-efficiency filter every 6 months, replace the HEPA filter every 1-2 years, and clean the return air vent weekly.

Fourth, ensure proper equipment maintenance; turn on the air conditioning 30 minutes in advance to maintain constant temperature and humidity, have designated personnel inspect and maintain it, clean the pre-filter and air outlet weekly, and replace the medium-efficiency and HEPA filters every 2 years based on air culture results.

3. Personnel management:

First, strictly control personnel entry and exit to reduce the frequency of entry and exit.

Second, ensure standardized attire; change into sterile clothing, wear shoes and hats, and strictly wash and disinfect hands upon entry.

Third, strengthen training to improve personnel's understanding of the working principles, environmental requirements, and operating procedures of the cleanroom, and reinforce aseptic concepts and operational discipline.

The core of a Class 100 cleanroom's sterile environment lies in air purification, but it relies even more heavily on comprehensive, all-round control and management. Only by strengthening usage management and implementing various maintenance requirements can its optimal environment and functionality be maintained, providing reliable assurance for relevant testing and operations.