喷雾干燥法生产无菌原料药的质量风险与控制

Quality risk and control of spray drying process in producing sterile API

喷雾干燥在药品生产中应用较多,喷雾干燥塔分为离心式、气流式、压力式,传统的喷雾干燥法生产无菌原料药过程中在不溶性微粒、无菌、均一性、有效成分降解等方面存在质量风险,应该针对性地在设备设计、清洁、灭菌、无菌粉冷却、混粉、环境控制等方面对各种风险加以严格控制,才能有效地生产出高品质的无菌原料药。

Spray drying is often used in pharmacoutical production. The spray drying tower may be centrifugal type, airflow type or pressure type. The traditional spray drying process has such defects as, insoluble particles, microbial contamination, homogeneity, effective component degradation etc. So the design, equipment cleaning, sterilization, sterile powder cooling, blending, environmental control and other aspects should be strictly controlled in order to produce high quality sterile drugs.