2015版英国药典灭菌法的翻译讲述.docxVIP

Appendix XVIII Methods of Sterilisation(Ph. Eur. general texts 5.1.1)Sterility is the absence of viable micro-organisms. The sterility of a product cannot be guaranteed by testing; it has to be assured by the application of a suitably validated production process. It is essential that the effect of the chosen sterilisation procedure on the product (including its final container or package) is investigated to ensure effectiveness and the integrity of the product and that the procedure is validated before being applied in practice. It is recommended that the choice of the container is such as to allow the optimum sterilisation to be applied. Failure to follow meticulously a validated process involves the risk of a non-sterile product or of a deteriorated product. Revalidation is carried out whenever major changes in the sterilisation procedure, including changes in the load, take place. It is expected that the principles of good manufacturing practice (as described in, for example, the European Community Guide to GMP) will have been observed in the design of the process including, in particular, the use of:无菌性是没有存活的微生物。一个产品的无菌性不能通过检测被保证;它必须通过适当验证的生产过程中的应用得到保证。至关重要的是，所选择的灭菌程序对产品的灭菌效果（包括其最终容器或包装）的影响进行了研究，以确保效力和产品的完整性，并且该过程在实践中被应用之前进行验证。建议在容器的选择是这样的，以允许要应用的最佳灭菌。不遵守验证过程将会导致产品的含菌或劣质产品。任何无菌生产过程的主要变更均需要重新验证，包括装载量的变化。可以预料，在良好生产规范原则（例如，在欧洲共同体指南GMP当中描述的）已经指出工程设计一定要包括：— qualified personnel with appropriate training,— adequate premises,— suitable production equipment, designed for easy cleaning and sterilisation,— adequate precautions to minimise the bioburden prior to sterilisation,— validated procedures for all critical production steps,— environmental monitoring and in-process testing procedures.? - 人才适当的培训，? - 充足的设施，? - 适用的生产设备，设计便于清洗和消毒，? - 足够的预防措施，以尽量减少灭菌前生物负荷，? - 验证所有关键生产步骤，? - 环境监测和过程测试程序。The precautions necessary to minimise the pre-sterilisation bioburden include the use of components with an acceptable low degree of microbial contamination. Microbiological monitoring a