Pharmaceutical purified water quality standard:

  • Resistivity: ≥0.5MΩ.CM
  • Conductivity: ≤2μS
  • Ammonia≤0.3μg/ml
  • Nitrate≤0.06μg/ml
  • Heavy metal≤0.5μg/ml

Typical pharmaceutical pure water preparation process

Raw water – raw water pressure pump – multi-media filter – activated carbon filter – water softener – precision filter – first stage reverse osmosis – PH adjustment – intermediate water tank – second stage reverse osmosis (the surface of reverse osmosis membrane is positively charged) – Purified water tank – Pure water pump – Ultraviolet sterilizer – Microporous filter – Reverse osmosis purified water water point

Recommend new process

Raw water – raw water pressurized pump – multi-media filter – activated carbon filter – water softener – precision filter – primary reverse osmosis equipment – intermediate water tank – intermediate water pump – ion exchanger – purified water tank – pure water pump – ultraviolet sterilizer – Microporous filter – point of use

Traditional craft

Raw water – raw water pressure pump – multi-media filter – activated carbon filter – water softener – precision filter – one stage reverse osmosis machine – intermediate water tank – intermediate water pump – EDI system – purified water tank – pure water pump – ultraviolet sterilizer – micro Pore ​​Filter – Water Point

Typical Purified Water Preparation System

Reverse osmosis method: The technology of preparing pure water by reverse osmosis method is a new technology developed in the 1960s. Because of its simple operation process, high demineralization and heat removal efficiency, and relatively economical. This method has been included in the 19th edition of the United States Pharmacopoeia, which is one of the statutory methods for preparing water for injection.
Mechanism: Reverse osmosis is the reverse process of osmosis, which refers to the process of forcing the solvent components in the solution to pass through a suitable semi-permeable membrane by means of a certain thrust (such as pressure difference, temperature difference, etc.) to block a certain solute component.

GMP certified pharmaceutical water requirements

GMP requirements for pharmaceutical water preparation equipment

  1. The structure design should be simple, reliable, and easy to disassemble.
  2. In order to facilitate disassembly, replacement and cleaning of parts, the design of the actuator should use standardized, generalized and systematic parts as much as possible.
  3. The surface of the inner and outer walls of the equipment should be smooth and flat, without dead angle, easy to clean and sterilize. The surface of the parts should be treated with chrome plating to resist corrosion and prevent rusting. Avoid using paint on the outside of the equipment to prevent peeling.
  4. The equipment for preparing purified water should be made of low carbon stainless steel or other materials that have been verified as not polluting the water quality. The equipment for preparing purified water should be cleaned regularly, and the cleaning effect should be verified.
  5. Materials in contact with 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. The equipment for preparing water for injection should be cleaned regularly, and the cleaning effect should be verified.
  6. The storage period of purified water should not be longer than 24 hours, and the storage tank should be made of stainless steel or other materials that have been proven to be non-toxic, corrosion-resistant and do not seep out polluting ions. To protect the vent, a hydrophobic sterilizing filter that does not shed fibers should be installed. The inner wall of the storage tank should be smooth, and there should be no dead ends and trachoma in the joints and welds. Sensors that display parameters such as liquid level, temperature and pressure that will not form stagnant water pollution should be used. The storage tank should be cleaned, disinfected and sterilized regularly, and the effect of cleaning and sterilization should be verified.
  7. Transportation of pharmaceutical water
    1) Purified water and pharmaceutical water should be transported by stainless steel pumps that are easy to disassemble, clean and sterilize. In the case of purified water and water for injection that need to be delivered by compressed air or nitrogen, the compressed air and nitrogen must be purified.
    2) Purified water should be transported by circulating pipeline. The piping design should be simple, and blind pipes and dead ends should be avoided. The piping should be made of stainless steel or other proven non-toxic, corrosion-resistant, and non-exuding contaminant ions. The valve should be a sanitary valve without dead angle, and the flow direction of the purified water should be marked.
    3) The pipelines and delivery pumps for transporting purified water and water for injection should be regularly cleaned, disinfected and sterilized, and can only be put into use after the verification is passed.
  8. The design of pressure vessels must be undertaken by licensed units and qualified personnel, and must be handled in accordance with the relevant provisions of the National Standard of the People’s Republic of China “Steel Pressure Vessels” (GB150-80) and “Pressure Vessel Safety Technical Supervision Regulations” .

Xi’an CHIWATEC Water Treatment Technology is a high-tech enterprise specialized in various water processing devices. Aside from these individual products, which cover a number of types and series, we can also help with related comprehensive engineering projects. Thanks to our hard work and dedication upon our founding, we are now one of the fastest-developing water treatment equipment manufacturers in Western China.

Further reading:

Water Treatment Systems & Reverse Osmosis in Pharmaceutical

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