The air shower is designed to remove dust from the surface of garments, typically located at the entrance of a cleanroom. Different factories have varying opinions on its installation—some place it in large infusion filling rooms or tablet workshops, while others, especially foreign pharmaceutical companies, may not use it in liquid preparation areas. This is because most external facilities add laminar flow hoods over open sections like bottle washing and filling, reducing the impact of personnel on the production line. Additionally, foreign companies emphasize strict cleanliness standards for workers, often requiring them to wear two layers of sterile outerwear under the laminar flow hood, eliminating the need for an air shower.
Air showers are generally installed in 100,000-grade clean areas, while 10,000-grade areas usually do not have air-conditioned rooms. When using an air shower, the number of users should be considered, and a bypass door should be provided for safe evacuation and to extend the lifespan of the system. This ensures that workers don't bypass the air shower unnecessarily, maintaining hygiene and efficiency.
The main purpose of personnel purification is to reduce contamination from human sources. To achieve the required air cleanliness in the production environment, proper purification procedures are essential.
(1) Personnel hygiene management: Establish health records, encourage good hygiene habits such as regular handwashing, bathing, nail cutting, hair trimming, and changing clothes. Smoking must be strictly prohibited.
(2) Purification process: Before entering the cleanroom, personnel must go through a series of purification steps. The process should be gradual, with a logical sequence to prevent contamination of cleaned areas by unclean parts during the procedure.
Common purification procedures in domestic cleanrooms include:
a. Non-sterile product production areas: Separate purification facilities should be set up for different cleanliness levels. Personnel entering 100,000- and 300,000-class areas must change into cleanroom attire. Procedures can be carried out in the same room if there's no full dressing area, or in two separate lines if needed. Hand sanitization can be integrated into the airlock chamber, which can also serve as a buffer zone.
b. Sterile cleanroom entry: Cleanroom garments should be washed separately according to their cleanliness level, dried, and packaged in a clean environment. Sterilizable garments should be placed individually in sterilization bags and then sterilized. Non-sterile garments should be stored properly after drying to avoid contamination.
Proper personnel purification not only enhances the quality of the production environment but also ensures compliance with strict regulatory requirements. It is a critical step in maintaining the integrity of the cleanroom and protecting sensitive processes from external contaminants.
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