Due to the drug production is strictly according to the batch production and testing, so the API equipment size is according to the process based on the amount of processing of a batch of material. Equipment in addition to prevent external microorganisms (mixed bacteria) and other miscellaneous bacterium with reaction of Chinese and foreign materials, and also should have in situ cleaning (Cleaninplace, CIP), the function of the in situ sterilization (Sterilizationinplace, SIP).

　　Filtering is to separate the liquid phase and solid phase of unit operations. Have a wide range of applications in the API production. According to the different process, which requires a clean such as the crystallization of finished product, etc.; And in addition to this filter, respectively.

　　In the API production process there are several to filter out clutter or fermented mycelia of operation. These operations have not entered the stage of clean processing, so in addition to miscellaneous fungi reproduction occasions extremely easily, do not set in situ sterilization function. While fully effective in situ cleaning function is a must. Such as fermented liquid filter used in the drum filter or plate and frame filter press and filter medium, such as its working space at the end of each batch operation, must be thoroughly cleaned and in order to prevent the breeding of fungus.

　　In the stage of finished product, such as before the finished product crystallization, the mother liquor and other material liquid into the mould must be to clean the filter. The filter medium is often tolerated the operation temperature aperture < 0.22 mu m membrane filter. The membrane filter before put into use shall be determined by distilled water flushing in stockpile, and the steam sterilization, and then down to room temperature. The crystallization is complete, crystallization and separation of the mother liquor, is done by crystal filters. Crystal filter before filtering crystal, go through the implement of the in situ cleaning and sterilization in situ. The crystal filters used in the filter medium, must be capable of sterilization temperature, chemical stability, not shedding fibers or particles. The filter medium also asked not holding crystal particles, in order to avoid these particles into the next batch number.

　　Active pharmaceutical ingredients in the production of many occasions require the compressed air, hot air, distilled water, sterile filtration of liquid raw materials and API solution, etc. For these different materials, different status, different temperature filtering, must be combined with specific conditions to choose the appropriate structure of filtering medium and filtering equipment, to complete in addition to bacteria, in addition to the operation of the particles. This is filtration unit must also have the requirement of in-situ cleaning and sterilization in situ. The filtering effect shall be verified effectively.

　　Active pharmaceutical ingredients and equipment as a pharmaceutical production hardware must comply with GMP standard. And filtration equipment as an important part of the API equipment, its also more and more strict. Equipment must be in strict accordance with the industry requirements, achieve clean requirements.

　　Note: in situ cleaning refers to the equipment does not need to move or remove can effectively clean, in order to prevent a batch of material or other impurities accumulated and into the next batch.

　　In situ sterilization is in the device after cleaning, and the walls of the equipment must be bright and clean and there is no depression structure, all corner requirements arc transition, sterilizing and cleaning. All the materials into the API related equipment, medium were required to be purified and reach the relevant standards.