Medical Device Cleanroom Solution

1. Medical device factories not only have high equipment costs, complex production processes, and high requirements for cleanliness and sterility, but also impose strict requirements on the qualifications of production personnel.

2. Potential biological hazards may arise during the production process, mainly including (infection risk, toxicity, sensitization, and other biological reactions of dead bacteria or cells and their components or metabolism to humans and other organisms, toxicity, sensitization, and other biological reactions of the product, and environmental effects). Clean Area: A room (area) where particulate matter and microbial contamination in the environment need to be controlled. Its building structure, equipment, and use are designed to prevent the introduction, generation, and retention of contaminants within the area.

Airlock: An isolated space with two or more doors located between two or more rooms (such as between rooms of different cleanliness levels). The purpose of setting up an airlock is to control airflow when personnel or materials enter or exit. Airlocks are divided into personnel airlocks and material airlocks. The basic characteristic of cleanrooms for medical devices is that particulate matter and microorganisms must be the objects of environmental control. Medical device manufacturing workshops are classified into four cleanliness levels: localized Class 100, Class 1000, Class 10000, and Class 30000 within a Class 100 or Class 10000 background.

Cleanroom temperature: 18–26 degrees Celsius, with relative humidity controlled between 45% and 65% unless otherwise specified.

Contamination control in medical device cleanrooms includes: source control, spread control, and cross-contamination control.