乳糖在非最终灭菌原料药无菌工艺模拟试验中的应用

目的 优选乳糖浓度替代TSB用于非最终灭菌原料药无菌工艺模拟灌装液态段的培养基。方法 根据乳糖的特性及车间非最终灭菌的无菌原料药生产工艺，考察不同浓度乳糖溶液的促生长能力，筛选出合适的乳糖浓度进行方法学验证，并采用该最适浓度乳糖溶液代替TSB培养基做无菌原料药结晶生产线液体介质模拟灌装试验。结果 5%和7%乳糖均可以作为培养基模拟灌装介质。从清洗角度来考虑，优选低浓度溶液。结论 5%乳糖溶液代替3%TSB溶液可作为非最终灭菌原料药无菌工艺模拟灌装液态段的培养基。

Application of Lactose in Process Simulation Testing for Non Terminal Sterilization Aseptically Raw Materials

OBJECTIVE to select perfect lactose concentration instead of TSB as the liquid culture medium to execute simulate filling at the liquid section which can reach the final API aseptic filling simulation requirements. METHODS Using the characteristics of lactose and the established final sterilization workshop of sterile API manufacturing process, investigated the growth promotional ability of different concentration of lactose, and then selected the appropriate lactose concentration for methodology validation. Finally this lactose was used instead of TSB culture medium to carry out filling simulation validation. RESULTS Using 5% and 7% lactose could be the simulate filling and the lower concentration of 5% lactose was recommend for its easier cleaning. CONCLUSION The 5% lactose instead of 3% TSB as the liquid culture medium to execute simulate filling at the liquid section can reach the final API aseptic filling simulation requirements.