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Design of aseptic powder injection workshop

  • الصنف:مركز المعرفة
  • الكاتب:
  • المصدر:
  • وقت الإصدار:2021-02-08 09:09
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【وصف الملخص】

Design of aseptic powder injection workshop

【وصف الملخص】

  • الصنف:مركز المعرفة
  • الكاتب:
  • المصدر:
  • وقت الإصدار:2021-02-08 09:09
  • الزيارات:
التفاصيل

  The production process of aseptic dispensing powder injection includes scrubbing and disinfection of raw and auxiliary materials, rough washing of vials, fine washing, sterilization and drying, rubber stopper treatment and sterilization, washing and sterilization of aluminum caps, dispensing, capping, and light inspection According to GMP regulations, the air cleanliness level of the production area is divided into A, B and D under the background of B level. Among them, aseptic filling, stoppering, capping of the vial out of the tunnel oven, rubber stopper out of the sterilizer and storage, etc. require a level A under the background of a local level B, scrubbing and disinfection of raw and auxiliary materials, final cleaning of the bottle stopper, and bottle The plug is dried and sterilized as Class D.

 

  The general key points and technical requirements for the design of the aseptic powder injection workshop are as follows:

 

  1:The design of the workshop should be based on the principle of separating people and logistics, according to the process flow and the correlation of the production process, organically arrange the functional areas with different cleanliness requirements to make the material flow short and smooth. The logistics of the powder injection workshop basically has the following types: raw materials, vials, rubber stoppers, aluminum caps, outsourcing materials and finished products out of the workshop. Personnel entering the workshop must go through different degrees of change to enter the Class D and Class B clean areas.

 

  2:The workshop is equipped with purification air conditioning and comfort air conditioning systems that can effectively control temperature and humidity, and can ensure the temperature and humidity requirements of the cultivation room; if there are no special process requirements, the temperature in the control area is 18~26℃, and the relative humidity is 45%~65% . Each process needs to install ultraviolet lamps for sterilization.

 

  3:The processes that need to remove heat and moisture in the workshop generally include bottle washing area, tunnel oven sterilization room, rubber plug aluminum cover room, rubber plug sterilization room, tool cleaning room, sanitary ware room, etc.

 

  4:Maintain a pressure difference of no less than 10Pa between clean areas of different levels, and each room should have a pressure measuring device. If it is to produce penicillin or other highly allergenic drugs, the filling room should maintain a relatively negative pressure.

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