Filtration equipment must comply with GMP standards Cleanliness requirements are the basics of the industry

Raw material equipment as a drug production hardware must comply with GMP standards. Filtration equipment as an important part of raw material equipment, its requirements have become increasingly stringent. Equipment must be strictly in accordance with industry requirements to achieve cleanliness requirements.

Filtration is a unit operation that separates the liquid and solid phases. Widely used in the production of APIs. According to the different processes, ie the crystals that require cleanliness, such as finished products; and the filtration other than that, they are processed separately.

In many areas of raw material production, compressed air, hot air, distilled water, liquid raw materials and raw material medicine solutions are required to be sterile filtered. For these different materials, different conditions, different temperatures of the filter must be combined with the specific conditions of the appropriate choice of filter media and filter device structure, to complete the sterilization and particle removal operations. This is because the filter device must also have the conditions for in-situ cleaning and in-situ sterilization.

There are a number of operations for removing impurities or fermentation broth to remove hyphae during the production process of the drug substance. These operations have not yet entered the cleansing stage and, therefore, no in-situ sterilizing function is provided except for occasions in which the fungi are highly prolific. Full and effective in-situ cleaning is a must. For example, drum filter or plate and frame filter press used in the fermentation broth filtration, such as its working space and filter media, must be thoroughly cleaned at the end of each batch of operations to prevent the proliferation of fungi.

As the production of drugs is strictly conducted and tested in batches, the size of APIs is based on the amount of material handled in the process. As a special commodity, the quality of medicines is particularly important. Therefore, in the filtration process, cleanliness is one of the most basic and most important requirements.

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