Design of GMP Purification Workshop for Powder Injection

Design of GMP Purification Workshop for Powder Injection

The production process of powder injection includes scrubbing of raw and auxiliary materials, rough washing of vials, fine washing, sterilization and drying, rubber stopper treatment and sterilization, aluminum cap detergent and sterilization, sub-packaging, capping, light inspection, Packaging and other steps; according to GMP regulations, the air cleanliness level of its production area is divided into 100, 10,000...

Text label: powder injection GMP workshop, powder injection purification workshop, purification workshop design

Design of GMP purification workshop for powder injection

The production process of powder injection includes scrubbing of raw and auxiliary materials, rough washing of vials, fine washing, sterilization and drying, rubber stopper treatment and sterilization, aluminum cap detergent and sterilization, sub-packaging, capping, light inspection, Packaging and other steps; according to GMP regulations, the air cleanliness levels in the production area are divided into 100, 10,000 and 100,000, including aseptic packaging, vials out of tunnel ovens, rubber plugs out of sterilizers and their storage. Local 100-level laminar flow protection, 10,000-level bottle stopper fine washing, bottle stopper drying and sterilization, 100,000-level environment for bottle cork rough washing and capping; the workshop design should be separated from personnel and logistics to make material flow short and smooth.

The air-conditioning system in the GMP workshop for powder injection can effectively control the temperature and humidity, and can ensure the temperature and humidity requirements of the cultivation clean room modular. If there are no special process requirements, the temperature of the control area is 18-26℃, and the relative humidity is 45%-65 %, UV lamps need to be installed in each process; heat and moisture removal devices need to be installed in the bottle washing area, tunnel oven sterilization room, rubber stopper aluminum cover room, rubber stopper sterilization room, tool cleaning room, sanitary ware room and other areas; There should be a pressure measuring device in each room, and a positive pressure difference of 5-10Pa should be maintained between clean areas of different levels. If penicillin is produced, the sub-packaging room should maintain a relatively negative pressure.

Freeze-dried powder injection cannot be sterilized after filling, and the production process must be aseptic. The production process of freeze-dried powder injection includes bottle washing and drying sterilization, rubber stopper treatment and sterilization, aluminum cap washing and sterilization The air cleanliness level of the production area of u200bu200bfreeze-dried powder injection is divided into 100, 10,000 and 100,000. Tubes with half stoppers, freeze-drying, and clean bottle stoppers are stored as 100-level or local 100-level in a 10,000-level environment, which is the sterile work area. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and purification workshops.

The layout of auxiliary rooms should be reasonable. The cleaning tool room and the container cleaning room should be located outside the sterile work area. Posts for non-sterile work should not be arranged in the sterile work area. Materials or other materials enter the sterile work area. In the operation area, a sterilization room or sterilization equipment for the disinfection or sterilization of materials and articles should be set up, and the washed containers should be disinfected or sterilized before entering the aseptic operation area; For the freeze-drying workshop of biological vaccine products, it is required to strictly distinguish the clean area, and to control and handle the air discharge of the live bacteria area and the sewage with live bacteria. The 100,000-level purification air-conditioning system mainly solves the second shift, the preparation of the culture medium, the sterilization of the culture medium and the washing of sterile clothes, the system returns air, and maintains a positive pressure of 5-10Pa with the live bacteria area; the 10,000-level purification air conditioner The system mainly solves the problems of inoculation, bacterial culture, bacterial collection, high pressure inactivation, washing and sterilizing of bottle plugs, cleaning and storage of tools, three shifts, and air conditioning purification of buffers. The air in the air system needs to be filtered by a high-efficiency filter to prevent the escape of live bacteria. In addition to the air-conditioning system, the design of the air-tightness of the workshop building, the piping arrangement of purified water and water for injection, and the discharge of pollutants should also have measures to prevent cross-contamination.

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