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Cleanroom cleaning and dressing process

2016-09-05 16:13:54
Article Source: Shenzhen Yong-clean Engineering Co., Ltd. Author: Admin Views: 1193
The changing channels of personnel entering the clean production area should be equipped with corresponding changing facilities according to the nature of production, product characteristics, and environmental requirements of the product, etc., and properly design the air flow organization, set the pressure difference and monitoring devices to meet the clean room Requirements for purification dressing.

I. Generally the following factors must be taken into account:

(1) Setting of changing room:

Separate rooms in different stages of changing clothes, such as changing shoes (removing outer clothing), wearing clean clothes (wearing sterile underwear, sterile outerwear), and air locks (washing hands, hand disinfection). The last air lock serves to isolate the air flow in the dressing area and the production area.

(2) Classification of dressing:

The new version of GMP clean room requires "the static level of the rear section of the dressing is consistent with the cleanliness level of its corresponding clean area". The rear section of the dressing refers to wearing clean clothes (wearing sterile outer clothes) and subsequent air locks. The cleanliness level of these areas is consistent with the level of the production area they serve. The pre-dressing area, as an auxiliary area for purifying and changing clothes, needs to be fed with air filtered by a HEPA filter, has a certain number of ventilations, and has a certain pressure gradient, but it is a non-graded area.

(3) The pressure difference in the dressing area:

The changing area serves as a channel for personnel to enter and exit the clean production area, and its pressure difference (airflow direction) basically flows from the higher-level area to the lower-level area. The pressure difference between adjacent air lock rooms is preferably 5Pa, so that after accumulation, the pressure difference between the clean area and the non-clean area will not be too high. As long as the pressure difference between different clean areas and clean and non-clean areas is controlled to be greater than 10Pa, if the pressure difference is too large, the leakage of air through the door gap will increase, and the strength requirements of the building partition will also be required. Increase.

Second, about the pressure difference monitoring in the changing area:

Because the cleanliness level of the rear section of the dressing change (clean clothes + air lock) is consistent with the production area, the pressure difference between these two areas must be monitored, so the differential pressure gauge will be set between these two rooms and other areas. In addition, according to the requirement that the pressure difference between the clean and non-clean areas must be greater than 10Pa, the pressure difference between this area and the area before the dressing should be greater than 10Pa.

Third, about the exit channel settings:

Class 100 dust-free workshops with high cleanliness requirements, as specified in Article 32 of the GMP, "when necessary, locker rooms entering and leaving the clean area can be set up separately." See the typical dressing layout for the airflow direction, clean zone, and differential pressure control of the exit channel.

Production of 10 cleanrooms that require cleanliness, such as high allergenicity, high activity, high toxicity, or small LD50 pharmaceuticals. If it is necessary to limit the leakage of air from the pharmaceutical production area, exit channels should be set in the dressing area and Pass the negative pressure trap to block the air flow in the production area.

For ordinary Class 1000 dust-free workshops, the exit channel can be designed similar to a gradient air lock. For ultra-high cleanness products, in order to prevent product-containing air from diffusing outward through the gradient air lock, a negative pressure air lock should be set to completely isolate the product-containing air.

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