Construction of GMP purification workshop for sterile eye drops
Construction of GMP purification pharmaceutical cleanroom for sterile eye drops
In the production process of sterile eye drops, the filling and sealing system is mainly for filling, plugging, capping, capping and conveying after the eye drops are prepared. Seal the complete set of aseptic guarantee requirements; the production environment of the whole line is B+A grade, from process layout, design...
Text label: Construction of sterile eye drops purification pharmaceutical cleanroom, GMP workshop engineering
Construction of GMP purification workshop for sterile eye drops
In the production process of sterile eye drops, the filling and sealing system is mainly for filling, plugging, capping, capping and conveying after the eye drops are prepared. Encapsulate a complete set of aseptic assurance requirements; the production environment of the entire line is B+A grade. From the aspects of process layout, design, component status, material, mechanism setting, airflow direction, protection measures, etc., first of all, no pollution, no cross-contamination, No distraction blocking. During the production of the whole line, the bottle does not stop, and it is continuous and smooth. The movements of bottle conveying and function transfer are soft, smooth, no impact, and no bottle pouring; the equal position is accurate to prevent the bottle body from being scratched or scratched.
Sterile eye drops filling and sealing line is composed of sterile eye drops water washing line and potting and sealing line. The sterilization system is composed of auxiliary bottle storage, ion air washing, purification protection zone and other equipment; The system is composed of auxiliary bottle accumulator, ion air washing, plug accumulator, material liquid buffer tank, cap accumulator, plug accumulator and other equipment; the capacity of general material liquid buffer tank is 20-30L, and the material liquid level is automatically controlled, which can be realized Online self-cleaning and sterilization; the whole line is equipped with a 100-level laminar flow hood system to achieve a dynamic 100-level environment in the production of the equipment line; the online environmental monitoring system is mainly equipped with laminar flow anemometer, dust particle monitoring, microbial sampling, sedimentation bacteria sampling, etc. , and input the test results into the centralized control system of the equipment program control system to ensure that the production environment meets the requirements and that the products are not polluted. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and sterile workshops.
The equipment of the whole line is arranged in the same room, and the environment is Class B/C. The room shall not be damaged, let alone the areas of different levels; when materials need to be conveyed by conveyor belts in areas with different high purification levels, they shall not be conveyed across areas. It can only operate in the same purification area; it can achieve full sealing protection from the equipment floor to the ground. If it is not sealed, leave enough height space to ensure smooth cleaning; the 100-level laminar flow hood is used to directly take the room clean. It is installed on the tempered glass cover frame on the top of the equipment, and is sealed and protected with the top of the room and the cover frame; the conduits are generally routed from the interlayer at the top of the room and hang down to the designated pre-point of the equipment, power lines, air pressure pipelines, etc. It is extended into the purification area after being set with a stainless steel tube.
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