Views:0 Author:Site Editor Publish Time: 2021-04-17 Origin:Site
The personnel closing channels entering the production area of clean workshops should set corresponding elsewear facilities according to the production properties, product characteristics, product requirements, etc., and rationally design air flow tissue, set differential pressure and monitoring equipment to meet dust-free The requirements of the workshop on purifying clothes.
Factors that need to be considered in a dressing process
1. Setting room
Different stages of the dress are separated by rooms, such as switching shoes (off-jackets), wear clean clothes (wear sterile underwear, sterile coat), gas lock (washing hands, hand disinfection), etc. Several rooms.
2. Clothing grading
The new GMP Dust-free workshop requirements \"The static level of the dressing is consistent with the clean level of its corresponding clean area.\" The rear segment of the dressing refers to the cleaning level of the wearer (wearing aseptic coat) and the subsequent air lock, which consistent with the production area of its services. For the front section of the dressing, as the auxiliary area of the purification, it is necessary to be sent to the air filtered through the HEPA filter. There is a certain number of ventilation, and there is a certain pressure gradient, but it belongs to an inregority area.
3. Differential difference value of the closure area
The elupural area is used as a person to enter the channel of the clean production area, and its pressure difference (airflow direction) flows substantially from a higher level of higher levels to the level. The pressure difference between the adjacent air locking rooms is preferably 5PA, so that the pressure difference between the clean zone and the non-cleaning zone will not be too high. As long as the differential differences between different clean regions and clean and non-cleaning zones are greater than 10Pa, if the pressure difference is too large, it will cause the air to increase the leakage of the door, and the strength requirements of the architectural partition must also Increase.
Since the cleansing level of the dressing (wearing a clean coat + air lock) is consistent with the production zone, the two regions must monitor its pressure difference, and the pressure difference gauge will be set between the two rooms and other regions. In addition, according to the clean and non-cleaning zone differential pressure, it must be greater than 10 Pa, and the differential pressure value of the region and its dressing front section should be greater than 10 Pa.
Exit channel settings
The level 100-level dust-free workshop of the cleanliness is required to separate the closing between the entry and leaving cleanser by means of the provisions of the GMP section 32. Exit the airflow direction, clean partition, and differential pressure control, etc. of the channel.
10 dust-free workshop production, such as highly sensitivity, high activity, high toxicity, or LD50, such as highly sensitivity, high activity, high toxicity, or LD50, if you need to limit the air leakage of the drug exposure production area, set out the passage in the closure area and By negative pressure traps to block the production area gas stream.
For ordinary 1000-level dust-free workshop, exit channels can be similar to gradient air lock design. For ultra-clean products, in order to avoid diffusion of the product air through the gradient air lock, a negative pressure gas lock should be provided to completely isolate the product air.