As a device integrating air purification and disinfection functions, the spray disinfection air shower plays a crucial role in the clean workshop of medical devices. Its core lies in the synergistic effect of atomized disinfectants and high-speed air flow to remove microorganisms and particles on the surface of personnel and items, ensuring that the clean workshop complies with GMP (Good Manufacturing Practice for Pharmaceutical Products) and other regulatory requirements. The specific application scenarios are as follows
I. Disinfection and purification of personnel entering the clean workshop
This is the most fundamental and frequently used application scenario for spray disinfection air shower rooms. The clean workshop for medical devices has extremely high requirements for the cleanliness of personnel. The clothes and skin surfaces of personnel are prone to carrying external microorganisms (such as bacteria and fungi) and dust particles. If they enter directly, they will contaminate the production environment and affect the sterility of medical devices (such as syringes and implantable devices).
Application process Personnel need to first change into clean suits and shoe covers. After entering the spray disinfection air shower room, the equipment automatically starts the atomization system to atomize disinfectants that meet medical standards (such as hydrogen peroxide, hypochlorous acid solution) into micron-sized particles, evenly covering the entire body of the personnel (including hidden parts such as the gaps, cuffs, and collar of the clean suit). At the same time, high-speed air shower airflow (with wind speed usually ≥25m/s) removes surface dust. The disinfection air shower time can be adjusted according to the level of the clean workshop. Generally, the disinfection time of the air shower room for Class A (sterile area) is 30 to 60 seconds, and for Class B (sterile auxiliary area), it is 20 to 30 seconds.
Typical scenarios: Sterile medical device production areas (such as heart stent assembly rooms), entrances to microbiological testing laboratories. It is necessary to ensure that the microbial load of personnel before entering is ≤10CFU per piece (on the surface of clean suits).
Ii. Pretreatment of raw materials and semi-finished products upon entry
Raw materials (such as metal tubes and high-molecular resin particles) and semi-finished products (such as unencapsulated tube blanks) required for the production of medical devices are prone to adhering environmental microorganisms and packaging debris on their surfaces during transportation and storage. If they are directly introduced into clean workshops, they will contaminate the production process and lead to substandard products.
Application process: Place raw materials/semi-finished products on dedicated clean trays and send them into the item passage of the spray disinfection air shower room (some equipment is equipped with an independent item air shower area). The atomized disinfectant is sprayed in all directions on the surface of the items, and at the same time, the high-speed airflow blows away the surface dust. For moisture-sensitive raw materials (such as certain polymer materials), a low-humidity atomization disinfection mode can be selected, or a hot air drying function can be combined to prevent the materials from getting damp and deteriorating.
Typical scenarios: Before raw materials for orthopedic implant devices (such as titanium alloy rods) enter the precision processing area and before semi-finished disposable medical gloves enter the aseptic packaging area, the surface microorganisms need to be controlled at ≤5CFU/cm² through this equipment.
Iii. Clean treatment after the transportation and maintenance of production equipment
Medical device production equipment (such as filling machines and sterilization cabinets) is prone to accumulate construction dust, oil stains and external microorganisms on its surface (including the casing, pipe joints and operation panels) after installation, maintenance or when transferred from non-clean areas to clean areas. If it is put into direct use, it will pollute the production environment and products.
Application process: The equipment is sent into the spray disinfection air shower room by forklift or track (a large-sized customized model should be selected to meet the equipment entry and exit requirements). After the equipment is started, multi-angle atomizing nozzles (usually 6-8 nozzles on the top and both sides) disinfect the surface of the equipment without dead corners, and the high-speed air shower airflow removes surface dust and residual disinfectant. For detailed parts such as equipment gaps and buttons, manual auxiliary disinfection can be used in combination to ensure a 100% disinfection coverage rate.
Typical scenarios: Before the aseptic liquid filling machine is transferred from the equipment maintenance area to the A-level filling area, and when the medical mask production line is adjusted and re-enters the clean workshop, it is necessary to achieve “zero introduction” of microorganisms through this equipment.
Iv. Cross-area disinfection between clean workshops
Some medical device clean workshops are classified into different clean level areas based on their functions (such as the raw material temporary storage area at grade B, the core production area at grade A, and the finished product inspection area at grade C). When personnel or items move across areas (especially from lower clean level to higher clean level), they are prone to carry microorganisms and particles from lower clean level areas, causing cross-contamination.
Application process: Spray disinfection air shower rooms are set up in the buffer zones of different cleanliness levels. When personnel/items enter the high-cleanliness area (such as Class C) from the low-cleanliness area (such as Class A), they need to go through the disinfection air shower process again, and the disinfection parameters must be higher than those in the low-cleanliness area (such as extending the disinfection time and increasing the disinfectant concentration) to ensure that the cross-regional contamination path is cut off.
Typical scenarios: When transferring semi-finished products from the B-level raw material temporary storage area to the A-level sterile production area, or when inspectors enter the A-level sterile sampling area from the C-level inspection area, they must complete secondary disinfection and purification through this equipment.
