summary

Solution Overview:

This plan is developed for the industrial filling, freeze-drying, and sealing of sterile freeze-dried penicillin bottle preparations (biologics, peptides, antibiotics, targeted drugs, sterile powder injections, etc.), strictly following the Chinese GMP, FDA, and EU GMP sterile drug production standards, focusing on the four core pain points of sterility assurance, process stability, product uniformity, and production compliance. Freeze dried formulations have extremely high requirements for production environment, drug control, filling accuracy, freeze-drying curve, and sterile sealing operation. Conventional open production lines are prone to quality problems such as particle contamination, microbial exceedance, large differences in loading volume, and freeze-drying collapse. This plan adopts an integrated mode of fully automatic closed linkage production line, sterile isolation system, and precise freeze-drying temperature control system, realizing the full chain automatic aseptic production of penicillin bottles from washing and drying sterilization, aseptic liquid preparation, precise filling, semi pressure plugging, freeze-drying treatment, full pressure plugging, capping sealing to finished product output. It is suitable for the large-scale, standardized, and compliant mass production of clinical aseptic freeze-drying preparations, and can also adapt to the flexible production needs of multi specification penicillin bottles。

Process flow:

Xilin bottle feeding → fully automatic bottle washing → hot air circulation de heating and sterilization → laminar cooling → sterile liquid preparation and sterilization filtration → A-class isolated sterile precise filling → automatic semi pressure plugging → automatic box entry → vacuum freeze-drying (pre freezing, sublimation, analytical drying) → vacuum full pressure plugging → box exit → automatic capping → lamp inspection and leak detection → finished product discharge → storage