summary

Lingyao is an integrated system designed specifically for the production of high standard sterile drugs, aimed at ensuring the sterility, accuracy, and safety of small volume injection production. This plan follows GMP standards and covers the entire process of ampoule cleaning, sterilization, filling, sealing, and leak detection. It is particularly suitable for drugs with unstable chemical properties that cannot tolerate the final sterilization process.

The core of the solution adopts automated sealing equipment in A/B clean environment, integrating high-efficiency air filtration (HEPA), laminar flow protection, online cleaning (CIP) and online sterilization (SIP) systems to effectively prevent pollution. The filling adopts servo drive or peristaltic pump to achieve high-precision filling of ± 0.5%~± 1%, and supports nitrogen protection (residual oxygen<1%) to ensure the stability of easily oxidizable drugs.

The equipment adopts a modular and L-shaped layout to reduce personnel intervention and lower the risk of cross contamination; The sealing process is tight, non carbonized, and easy to break. The entire process is equipped with a SCADA system that meets the requirements of 21 CFR Part 11 to ensure data traceability. This plan has high automation and compliance, and is suitable for the efficient and safe production of sterile injections in pharmaceutical enterprises。