Material purification measures in preparation GMP workshop
Material purification measures in preparation GMP workshop
The raw and auxiliary materials and inner packaging materials in the preparation GMP workshop should be dedusted, unpacked and peeled in the external treatment room, put into special containers or sent to the control area through conveyor belts or special freight elevators from the conveyor cabinet. Remove or wipe the dust on the outer packaging; there should be a buffer in the cargo elevator...
Text label: preparation GMP workshop, GMP workshop design and installation, material purification measures
Material purification measures in preparation GMP pharmaceutical cleanroom
The raw and auxiliary materials and inner packaging materials in the preparation GMP workshop should be dedusted, unpacked and peeled in the external treatment room, put into special containers or sent to the control area through conveyor belts or special freight elevators from the conveyor cabinet. Remove or wipe the dust on the outer packaging; there should be a buffer front room in the freight elevator room to reduce the dust pollution in the control area caused by the airflow during the elevator operation, an axial flow fan can be installed on the outer wall of the machine room to enhance the negative pressure of the hoistway; The material purification system entering the D-level clean area in the general area includes: outsourced cleaning and disinfection treatment room, transfer window, disinfection and buffering. The window goes to the buffer room to sterilize the outer packaging again, and then enters the temporary storage room for use.
The function of the airlock room or transfer window is also to maintain the air cleanliness and positive pressure in the clean area. The method of the transfer window: set windows on both sides of the door to see the inside and both sides, and the doors on both sides should be interlocked , can not be opened at the same time; the size of the window should be able to adapt to the size and quantity of the goods to be transported, with air tightness and certain strength; the transfer window connected to the clean area should be equipped with sterilization measures in the window, and the conveyor belt for transferring materials must not be The clean room directly enters the clean room. Unless the conveyor belt is continuously sterilized, it can only be transported in sections on both sides of the transfer window; Destruction of cleanliness is a device that temporarily blocks airflow through, and is a measure to prevent contamination with the passage of items. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and purification workshops.
The most common types of transfer windows: mechanical, there are two sashes inside and outside the transfer window, and mechanical interlocking is used in the middle, that is, when one sash is opened, the other sash is closed and cannot be opened; sterilization, in the window There is a UV lamp installed in the body to use and transmit objects that may have bacteria in the window. After opening the window and putting in the object, close the window and turn on the UV lamp, and then open the window on the other side for a few minutes to take the object; airlock type, transfer There are fans and HEPA filters in the form. The material of the transfer window should also be paid attention to. Do not use wood material, otherwise it will be easily deformed and the sealing performance will be poor.
At the same time, as the recent research of PHARMA shows, the benefits of improved productivity and firm performance can make implementing basic management practices worth it.
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