无菌sterility是指在任一指定的物体、介质或环境中无任何活的微生物。

Refers to any given object, medium or environment, without any living organisms.

除菌：使用物理、化学灭菌法Using physical, chemical sterilization and Asepticmethod如：0.22μm的微孔滤膜除菌、使用消毒剂、防腐剂。无菌操作法。0.22μm microporous membrane, the use of disinfectants and preservatives.

热原pyrogen

是指够致热的微生物的尸体及其代谢产物，即微生物的一种内毒素，是由磷脂、脂多糖和蛋白质所组成的复合物，脂多糖是主要成分，具有特别强的热原活性。

Refers to the bodies of Microorganisms and its metabolites that can cause fever, that is a kind of micro-organisms endotoxin, which is a kind of complex composed of phospholipids LPS and protein, LPS is a major component, with particularly strong pyrogen activity.

热原具耐热性、滤过性、水溶性、不挥发性、被吸附性。

去除热源：高温法、酸碱法、吸附法、离子交换法、凝胶过滤法、反渗透法。活性碳常温吸附

High-temperature method, pH, adsorption, ion exchange, gel filtration, reverse osmosis. Activated carbon adsorption at room temperature

除氧，尽量减少药物与空气的接触，在配液和灌封中通入惰性气体，常用高纯度的氮气和二氧化碳。(2)加抗氧剂。(3)调节溶液pH在最稳定pH范围。(4)加金属离子络合剂。

Oxygen, drugs to minimize contact with air, in communication with fluid and potting ininert gas, commonly used in high-purity nitrogen and carbon dioxide. (2) plusantioxidants. (3) adjusting the solution pH in the most stable pH range. (4) with metalion complexing agent.