The water for injection is pyrogen-free distilled water, which is obtained by filtering the purified water (deionized water) and then filtering it by a 0.22 m to 0.10 m sterilizing filter. For the preparation of pure water, there is currently a pyrogen-free distilled water for the whole injection water, which is obtained by filtering with purified water (deionized water) and then filtering through a 0.22 μm to 0.10 μm sterilization filter. For the preparation of pure water, there are currently all ion exchange methods, electrodialysis-ion exchange methods, first-order reverse osmosis-ion exchange methods, and two-stage reverse osmosis methods. Regardless of the process used to prepare pure water, the raw water supplied with distilled water to prepare distilled water must meet the pure water quality standards stipulated by the Chinese Pharmacopoeia.
The water for injection is prepared by distillation, and in theory, it can remove fine substances in water (all non-volatile substances larger than 1 μm and most soluble small-molecular inorganic salts of 0.09 to 1 μm). After the pure water is distilled, impurities such as non-volatile organic and inorganic substances including suspensions, colloids, bacteria, viruses, pyrogens and the like can be removed. However, due to the structure, performance, metal materials, processing accuracy, operation methods and water quality of the water source, the quality of the distilled water is inevitably affected.
Characteristics of preparation of water for injection
Water for injection is the most widely used in the production of aseptic preparations. The quality requirements for water for injection have been strictly regulated in the Pharmacopoeia. Except for general distilled water inspection items, such as pH and water for injection are the most widely used in the production of sterile preparations. One type, the quality requirements for water for injection have been strictly regulated in the Pharmacopoeia, except for the general inspection items of distilled water, such as pH,
Chlorides, sulfates, calcium salts, ammonium salts, carbon dioxide, oxides, non-volatiles and heavy metals are all subject to the requirements and must be examined by pyrogens. GMP clearly stipulates that “preparation, storage and distribution of purified water and water for injection should prevent the growth and pollution of microorganisms. The materials used in storage tanks and pipelines should be non-toxic and corrosion resistant. The vents of water tanks for injection should be installed without falling off. The hydrophobic sterilizing filter of the fiber. The water for injection can be stored at 80 ° C or higher, at 65 ° C or above or at 4 ° C or below.
Quality requirements for water for injection
Water for injection is used to prepare a solvent for injecting a liquid medicine and a sterile rinsing agent, or for washing bottles (fine washing), rubber stopper final washing, pure steam generation and medical treatment for the production of sterile powder, infusion, water needle and the like. Clinically water soluble injection powder solvent. Because the formulated drug is directly used for intramuscular or intravenous drip, it is specially injected into the body with a needle. Its quality requirements are particularly high, and it should be provided with various injections.
The same requirements are aseptic, pyrogen-free, clarity, resistivity should be >1MΩ/cm, bacterial endotoxin <0.25EU/ml, microbial index <50CFU/ml. The remaining standards of water quality should be in line with the pure water quality chemical indicators and the total organic carbon concentration (ppb level). This can be inserted into the water supply or return pipe of the injection water by using a special total organic carbon analyzer. It can be directly monitored and the resistivity and temperature values can be measured simultaneously.
In addition to the requirements of pure water, the number of colonies is less than 50 CFU/ml, and it is still required to pass the pyrogen test. According to GMP regulations, pure water and water injection systems must pass GMP verification before they can be put into use. If the product needs to be exported, it must also meet the corresponding requirements of USP, FDA, cGMP, etc. In order to facilitate the use of standards that can be based on the effects of various treatment techniques on the removal of impurities in water, Table 1 lists the requirements of US GMP for water quality and the treatment technologies contained in our GMP Implementation Guidelines to remove impurities from water.
The preparation, storage and distribution of water for injection should prevent the growth and contamination of microorganisms. The materials used in storage tanks and pipelines should be non-toxic and corrosion resistant. Pipes should be designed and installed to avoid dead ends and blind pipes. Storage tanks and pipelines shall have a cleaning and sterilization cycle. The venting port of the water tank for injection should be installed with a hydrophobic sterilizing filter that does not shed fibers. The water for injection can be stored at 80 ° C or higher, at 65 ° C or above, or at 4 ° C or below. Pipes used in pretreatment equipment for water for injection are generally made of ABS engineering plastics, but also PVC, PPR or other suitable materials. However, the distribution system of purified water and water for injection should use the corresponding pipeline materials such as chemical disinfection, pasteurization, heat sterilization, etc., such as PVDF, ABS, PPR, etc., preferably stainless steel, especially the 316L model is the best. Stainless steel is a general term and is strictly divided into stainless steel and acid-resistant steel. Stainless steel is a steel that is resistant to corrosion by weak media such as atmosphere, steam and water, but it is not resistant to corrosion by chemically aggressive media such as acid, alkali or salt, and has rust properties.