Purified water standard

First of all, when it comes to the pharmaceutical industry and pharmaceutical water, it must be acknowledged that the minimum quality standard of pharmaceutical water is drinking water, if it meets the GB drinking water, it is a kind of pharmaceutical water, if not, it must be purified in the water production room, at least to meet the drinking water standards before being transported to the point of use.

Whether tap water, well water, river water, lake water, or mountain spring water, there is only one principle in the pharmaceutical industry as a source water: if the source water meets or exceeds the drinking water, it is the minimum standard pharmaceutical water, if not, it needs to be treated. Because Chinese pharmaceutical enterprises can not get safe and stable drinking water as the source water from the municipal pipe network system, therefore, there will be differences with European and American developed countries in the formulation of pharmacopoeia standards and the implementation of GMP.

First, talk about the purified water preparation method, a concept: Purification water, source water (drinking water) + appropriate purification process = pharmacopoeia purified water, objectively speaking, drinking water +RO/EDI can prepare purified water, so, foreign purification water specifically refers to RO/RO or RO/EDI such devices (the premise is drinking water and above), domestic because there is no drinking water, so, Chinese pharmaceutical industry usually defaults the purification water dispenser to 'pretreatment facility + purification facility' two parts. For this reason, similar EDI module design is different in China, Europe and the United States. For example, in the United States, because some enterprises directly use drinking water as raw water without pretreatment facilities, the concentrated water outlet of EDI module is designed separately from the polar water outlet, and the concentrated water outlet can generally be directly back before RO. The polar water outlet is suggested to directly discharge or return to other front-end processes that can remove residual chlorine. However, in China, because EDI concentrated water and polar water can be directly returned to the pre-treated original water tank, the EDI module design of some manufacturers using the combination of concentrated water mouth and polar water mouth directly back to the original water tank is also in line with the requirements.