Clean rooms are usually used as part of professional industrial production or scientific research, including the manufacture of drugs, integrated circuits, CRT, LCD, OLED displays, etc. Pharma Clean rooms are designed to keep extremely low levels of particulates, such as dust, airborne organisms, or vaporized particulates. To be precise, a clean room has a controlled contamination level that is defined by the number of particles per cubic meter at a specified particle size. Clean rooms use HEPA or ULPA filters with different airflow principles to control particles in the air. Due to the strict requirements of manufacturing technology upgrading in the production environment, clean rooms are also known as the patron saint of high-end manufacturing.

• There are three key points to maintaining a cleanliness level

1. Design of cleanroom

To comply with GMP and achieve cleanliness specifications, all surfaces of the clean room should be smooth and airtight, and not produce pollution, that is, do not produce dust, corrosion resistance, and easy to clean. The surface should be strong and durable, without cracking, crumbling, or dents. Regular cleaning and disinfection according to the requirements of clean rooms at all levels.

2. Air control inside of cleanroom

In general, it is necessary to choose the right clean room design, regular maintenance, and daily monitoring. Special attention should be paid to the monitoring of floating bacteria in the pharmaceutical clean room, and the microorganisms in the laminar flow layer also need to be detected. If compressed gas is used in the aseptic room, it is also necessary to perform microbial tests on the compressed air.

3. Personnel Requirement

Clean room staff should receive regular training on pollution control theory. They enter and exit the cleanroom through airlocks, air showers, and changing rooms and must wear professional clothing.

Cleanroom clothing is used to prevent particles and or microorganisms from being released from the wearer's body and contaminating the environment. It must not release particles or fibers to prevent pollution of the environment. Clean protective equipment includes protective clothing, boots, shoes, round hats, masks, gloves, finger covers, and boot covers. The type of cleanroom clothing used should reflect the cleanroom and product category. Class 10,000 clean rooms can use simple lab clothes, head covers, and shoe covers. For Class 100 cleanrooms, full body wrap, zippered protective clothing, goggles, face masks, gloves, and boot covers are required.

•  Common disinfection methods for clean rooms

(1) Ultraviolet lamp disinfection and sterilization

(2) Ozone disinfection

(3) Gas sterilization

(4) Disinfectant

Suzhou Pharma Machinery Co.,Ltd.

2024/04/22

Tia