Wuhan's sterile workshop is typically a small room designated within a microbiology laboratory. It can be constructed using panels and glass. The area should not be too large, around 4 to 5 square meters, with a height of approximately 2.5 meters. A buffer room should be set up outside the sterile workshop, with the doors of the buffer room and the sterile workshop not facing the same direction to prevent the introduction of contaminants through air flow. Both the sterile workshop and the buffer room must be sealed. The ventilation equipment inside should be equipped with an air filtration system.

Technical Features of the Sterile Workshop

Airflow within an aseptic workshop presents two scenarios: one is laminar flow (where all suspended particles in the room remain within the laminar flow layer); the other is turbulent flow (where the air movement within the room is chaotic). Cleanrooms equipped with conventional HVAC systems exhibit turbulent airflow, which can quickly mix suspended particles in the air, cause settled particles to become airborne again, and lead to some air becoming stagnant.

Regulations for Sterile Workshop Management

1. Entry into the sterile workshop management encompasses the control of personnel access, material entry, transportation of equipment, and maintenance of related equipment and pipelines, ensuring that no particles or microorganisms are introduced into the sterile workshop.

2. Operational management technology for the production, wearing, and cleaning of clean workwear for personnel in sterile workshops; the movement and actions of operators; the selection and cleaning, as well as disinfection of indoor equipment and decorative materials, to minimize, prevent, and control the generation, retention, and reproduction of dust particles and microorganisms in sterile workshops as much as possible.

3. Enforce strict maintenance and management of all equipment and facilities, establish corresponding operational procedures to ensure normal operation as required, including purification HVAC systems, various water, gas, and electrical systems, production process equipment, and tools (fixtures and jigs). This ensures compliance with product production process requirements and air cleanliness levels.

4. Cleaning and Sterilization Management: Clearly define the cleaning, sterilization, methods, cycles, and inspections for all equipment and facilities within the aseptic workshop to prevent, remove, and eliminate the generation, retention, and proliferation of dust particles and microorganisms.

5. The content of aseptic workshop environmental control includes: air purification, clean construction, control of contaminants in water, gas, or chemicals that come into direct contact with products, as well as production equipment and tools, and the control and prevention of micro-vibration, noise, and static electricity.