Clean room clean dressing process
2016-09-05 16:13:54
Personnel entering the clean production area of changing channel should be based on the nature of production, product features, product-level environmental requirements, set the appropriate changing facilities, and rational design of air distribution, and set differential pressure monitoring device, in order to meet the clean room purification of changing requirements.
One, usually the following factors must be considered:
(1), dressing room settings:
The different stages of the dressing to be separated, such as by changing his shoes (off coat), wear clean clothes (underwear wear sterile, sterile coat), airlock (hand washing, hand disinfection) aliquot of several rooms with room. Finally, an air lock, for isolation dressing area and production area airflow effect.
(2), changing classification:
The new GMP clean room requirements "consistent cleanliness level after changing the static level segment and its corresponding clean areas." The changing of the rear section, referring to wear clean clothes (wear sterile cloak) and subsequent air lock, consistent production areas in these regions the level of cleanliness and its service level. The front dressing area, dressing as a purifying auxiliary area need fed through the HEPA filter air, a certain number of air changes, there is a certain pressure gradient, but do not belong to the classification zone.
(3), pressure dressing area values:
Dressing area as personnel out of the clean production area of the channel, the pressure (air flow direction) from the basic level to a higher level of regional low flow region. Differential pressure between rooms adjacent airlock to 5Pa appropriate, so the cumulative after pressure clean area and non-clean areas is not excessively high. As long as the pressure of different clean area and clean and non-clean area between greater than 10Pa can control, such as too much pressure will cause air leakage through the door increases, while building strength requirements should be cut off increases.
Second, on the dressing area pressure monitoring:
Since the changing of the rear section (wear clean clothes + airlock) production areas clean and consistent level, so that the two regions must monitor their pressure, so the pressure gauge is set in between the two rooms and other areas. Also, according to clean and non-clean area must be greater than 10Pa pressure requirements, the differential pressure value of the area and its changing front area should be greater than 10Pa.
Third, on the exit channel settings:
High cleanliness requirements of 100 clean room according to GMP Article 32 stipulates that "if necessary, you can enter and leave the clean area of the locker room set apart." Exit channel airflow direction, clean the partition, pressure control, see the typical layout changing.
Out of 10 for cleanliness requirements of clean room production, such as highly sensitizing, high activity, high toxicity, or LD50 small system drugs, such as the need to limit the exposure of the drug production areas of air leakage in the dressing area to set an exit passage and negative pressure wells, production area to block the airflow.
For ordinary 1000 clean room, exit channel can be similar gradient airlock design. For ultra-high purity products, in order to avoid products containing air outward diffusion gradient through the air lock, the lock should be set to a negative pressure air to air containing products complete isolation.
One, usually the following factors must be considered:
(1), dressing room settings:
The different stages of the dressing to be separated, such as by changing his shoes (off coat), wear clean clothes (underwear wear sterile, sterile coat), airlock (hand washing, hand disinfection) aliquot of several rooms with room. Finally, an air lock, for isolation dressing area and production area airflow effect.
(2), changing classification:
The new GMP clean room requirements "consistent cleanliness level after changing the static level segment and its corresponding clean areas." The changing of the rear section, referring to wear clean clothes (wear sterile cloak) and subsequent air lock, consistent production areas in these regions the level of cleanliness and its service level. The front dressing area, dressing as a purifying auxiliary area need fed through the HEPA filter air, a certain number of air changes, there is a certain pressure gradient, but do not belong to the classification zone.
(3), pressure dressing area values:
Dressing area as personnel out of the clean production area of the channel, the pressure (air flow direction) from the basic level to a higher level of regional low flow region. Differential pressure between rooms adjacent airlock to 5Pa appropriate, so the cumulative after pressure clean area and non-clean areas is not excessively high. As long as the pressure of different clean area and clean and non-clean area between greater than 10Pa can control, such as too much pressure will cause air leakage through the door increases, while building strength requirements should be cut off increases.
Second, on the dressing area pressure monitoring:
Since the changing of the rear section (wear clean clothes + airlock) production areas clean and consistent level, so that the two regions must monitor their pressure, so the pressure gauge is set in between the two rooms and other areas. Also, according to clean and non-clean area must be greater than 10Pa pressure requirements, the differential pressure value of the area and its changing front area should be greater than 10Pa.
Third, on the exit channel settings:
High cleanliness requirements of 100 clean room according to GMP Article 32 stipulates that "if necessary, you can enter and leave the clean area of the locker room set apart." Exit channel airflow direction, clean the partition, pressure control, see the typical layout changing.
Out of 10 for cleanliness requirements of clean room production, such as highly sensitizing, high activity, high toxicity, or LD50 small system drugs, such as the need to limit the exposure of the drug production areas of air leakage in the dressing area to set an exit passage and negative pressure wells, production area to block the airflow.
For ordinary 1000 clean room, exit channel can be similar gradient airlock design. For ultra-high purity products, in order to avoid products containing air outward diffusion gradient through the air lock, the lock should be set to a negative pressure air to air containing products complete isolation.
