GMP certified pharmaceutical water requirements
1. Classification of pharmaceutical water and water quality standards
1. Pharmaceutical water (process water: water used in the production process of pharmaceuticals, including drinking water, purified water, water for injection)
1) Drinking water (Potable-Water): Tap water or deep well water, also known as raw water, usually supplied by the water company. Its quality must conform to the national standard GB5749-85 "Sanitary Standard for Drinking Water". According to the 2010 Chinese Pharmacopoeia, drinking water cannot be directly used as preparation or test water for preparations.
2) Purified Water: Pharmaceutical water obtained by distillation, ion exchange, reverse osmosis or other suitable methods, without any additives. Purified water can be used as a solvent or test water for formulating common pharmaceutical preparations, and should not be used for the preparation of injections.
Purified water prepared by non-heat treatment such as ion exchange method, reverse osmosis method, ultrafiltration method or the like is generally called deionized water.
Purified water prepared by distillation using a specially designed distiller is also generally referred to as distilled water.
3) Water for Injection: Water obtained by purifying the purified water as a raw water, distilling it through a specially designed distiller, cooling and cooling, and then filtering through a membrane.
Water for injection can be used as a solvent for formulating an injection.
4) Sterile Water for Injection: The water obtained by the injection production process is water for injection.
Sterilized water for injection is used as a diluent for the solvent or injection of the sterilized powder.
2. Water quality standards for pharmaceutical water
1) Drinking water: It should meet the national standard of the People's Republic of China, "Sanitary Standard for Drinking Water" (GB5749-85)
2) Purified water: It should meet the purified water standard contained in the 2010 Chinese Pharmacopoeia.
In the water production process, the value of the resistivity of the purified water is usually detected online to reflect the concentration of various ions in the water. The resistivity of purified water in the pharmaceutical industry should generally be ≥ 0.5MΩ.CM/25°C, and the resistivity of purified water for injection and eye container should be ≥ 2MΩ.CM/25°C.
3) Water for injection: It should meet the standard of water for injection contained in the 2010 Chinese Pharmacopoeia.
Second, GMP requirements for pharmaceutical water preparation equipment
1. The structural design should be simple, reliable, and easy to assemble and disassemble.
2. In order to facilitate the disassembly, replacement, and cleaning of parts, the design of the actuator is standardized, generalized, and systematically used as much as possible.
3, the inner and outer wall surface of the equipment, requires smooth and flat, no dead angle, easy to clean and sterilize. The surface of the part should be surface treated with chrome plating to resist corrosion and prevent rust. Avoid using paint outside the equipment to prevent peeling.
4. Preparation of purified water equipment should use low carbon stainless steel or other materials that have been verified to not pollute the water. Equipment for the preparation of purified water should be cleaned regularly and verified for cleaning results.
5. The materials in contact with the water for injection must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials that have been verified to not pollute the water. Equipment for the preparation of water for injection should be cleaned regularly and verified for cleaning results.
6. The storage period of purified water should not be more than 24 hours. The storage tank should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant and do not bleed out contaminated ions. The venting port should be protected by a hydrophobic sterilizing filter that does not shed fibers. The inner wall of the tank should be smooth, and the joints and welds should have no dead angles and trachoma. Sensors that display parameters such as liquid level and temperature pressure that do not form stagnant water contamination should be used. The storage tank should be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effects should be verified.
7. Delivery of pharmaceutical water
1) Purified water and pharmaceutical water should be transported by a stainless steel pump that is easy to disassemble and clean. Where purified water and water for injection are required to be compressed by compressed air or nitrogen, compressed air and nitrogen must be purified.
2) Purified water should be transported by circulating pipeline. The piping design should be simple and blind tubes and dead ends should be avoided. Pipes shall be made of stainless steel pipes or other pipes that have been verified to be non-toxic, corrosion-resistant and do not bleed out contaminated ions. The valve should be a hygienic valve with no dead angle, and the purified water should be marked with the flow direction.
3) Pipes and pumps for conveying purified water and water for injection should be cleaned, disinfected and sterilized regularly, and can be put into use after verification.
8. The design of the pressure vessel shall be undertaken by the licensed unit and qualified personnel, and shall be handled in accordance with the relevant provisions of the People's Republic of China National Standard "Steel Pressure Vessel" (GB150-80) and "Pressure Vessel Safety Technical Supervision Regulations". .
Third, a typical purified water preparation system
Reverse osmosis method: The reverse osmosis method for the preparation of pure water technology is a new technology developed in the 1960s. Because of its simple operation process, the desalination and heat removal sources are highly efficient and economical. The United States Pharmacopoeia began collecting this method from the 19th edition as one of the statutory methods for preparing water for injection.
1 Mechanism: Reverse osmosis is the reverse process of osmosis. It refers to the process of forcing a solvent component in a solution through a suitable semipermeable membrane to retain a solute component by a certain thrust (such as pressure difference, temperature difference, etc.). The process of preparing water for injection by reverse osmosis method is: raw water→pretreatment→first-stage high-pressure pump→first-stage reverse osmosis device→ion exchange resin→secondary high-pressure pump→second-stage reverse osmosis device→pure water
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