The reverse osmosis process uses a semi permeable spiral wound membrane to separate and remove soluble solids, organic matter, colloidal substances, and bacteria from water. The raw water is sent under a certain pressure and passes through a reverse osmosis membrane. The water passes through the small pores on the membrane and is collected to obtain pure water. Impurities in the water are concentrated and discharged in the intercepting liquid. RO can remove over 96% of dissolved solids, over 99% of organic matter and colloids, and almost 100% of bacteria from raw water. Secondary reverse osmosis device
Application of Secondary Reverse Osmosis Water Treatment Process
The current advanced water treatment technology, the secondary reverse osmosis water treatment process, has broad application prospects in pharmaceutical production, especially in the GMP transformation of enterprises. Adopting this process not only ensures that the treated water meets the purified water standards specified in the pharmacopoeia, but also avoids environmental pollution that may occur with traditional processes and effectively reduces water treatment costs.
Water is a raw material in pharmaceutical production. In the production of tablets, capsules, oral liquids, and topical medications, all equipment, containers, inner packaging, and tools that come into contact with the drugs must be cleaned with pure water; In the production of sterile preparations, containers, inner packaging, and tools that come into contact with drugs must be cleaned with distilled water; The production of large infusion and injection requires a large amount of distilled water. Whether the water treatment process and equipment are advanced directly affects the quality and cost of drug production. For many years, the traditional process of pharmaceutical companies in China cannot do without ion exchange. The regeneration of ion exchange requires the use of acid and alkali, equipped with acid and alkali storage tanks and neutralization tanks, which not only causes environmental pollution but also increases equipment investment.
Reverse osmosis is one of the effective water treatment methods in modern technology. Its principle is that when dilute solutions (such as fresh water) and concentrated solutions (such as seawater or saltwater) of the same volume are placed on both sides of the same container, separated by a semi permeable membrane in the middle, the solvent in the dilute solution will naturally flow through the semi permeable membrane to the concentrated solution side, causing the liquid level on the concentrated solution side to be higher than that on the dilute solution side by a certain height, forming a pressure difference and reaching osmotic equilibrium. This pressure is called osmotic pressure (the magnitude of osmotic pressure depends on the type of concentrated solution). If a pressure greater than the osmotic pressure is applied to one side of the concentrated solution, the solvent in the concentrated solution will flow towards the dilute solution in the opposite direction of the original permeation direction, called reverse osmosis. Reverse osmosis is a membrane separation technology driven by pressure. When the pressure applied in the water treatment system is greater than the osmotic pressure of the aqueous solution, water molecules will continuously pass through the membrane, flow into the central pipe through the water production channel, and then flow out from the outlet end. Impurities such as ions, organic matter, and bacteria in the water will be intercepted on the inlet side of the membrane and flow out from the outlet end of the concentrated water, thus achieving the purpose of separation and purification.
Secondary reverse osmosis device
The secondary reverse osmosis process requires the use of reverse osmosis twice in the water treatment process. The brief process is as follows: first, the raw water is sent to the raw water tank through a pipeline, and then pressurized and enters the mechanical filter; Inject flocculant through a chemical metering pump between the raw water and the mechanical filter to further coagulate suspended solids in the water and filter them through the mechanical filter; Further remove residual chlorine and organic matter from the water through an activated carbon filter, so that the pre treated water meets the qualified standards. Before the qualified pre-treatment enters reverse osmosis, a chemical metering pump is used to inject scale inhibitor to prevent scaling of the reverse osmosis membrane. Then, it passes through a security filter and is pressurized by a high-pressure pump before entering the first stage reverse osmosis device; After passing through the first stage reverse osmosis device, the produced water enters the intermediate water tank, adjusts the pH value, and then entersSecondary reverse osmosis deviceAfter undergoing secondary reverse osmosis treatment, the produced water enters the water production tank and then undergoes terminal filtration to become qualified purified water. It can be directly transported to various water consumption points or used in the distilled water machine to prepare distilled water.
Compared with traditional water treatment processes, the secondary reverse osmosis process does not require ion exchange, which means it does not require the acid and alkali required for ion exchange regeneration, and does not require acid-base storage tanks or neutralization tanks. This effectively avoids environmental pollution caused by the use of traditional processes and reduces equipment costs. In addition, the secondary reverse osmosis process can also remove colloidal substances, organic compounds, iron ions, and silica that are difficult to remove by traditional processes; Improve the adaptability of water treatment equipment to changes in raw water quality and the reliability of effluent quality; Improve the automation level and technological content of water treatment systems; Reduce the labor intensity of operators, etc.
In the past two years, the secondary reverse osmosis process has been favored by many pharmaceutical companies. Our company has designed and installed secondary reverse osmosis water treatment systems for hundreds of pharmaceutical companies, and many of their production lines have passed GMP certification.
The document describes the production of purified water that meets the quality requirements of the 2015 edition of the Chinese Pharmacopoeia, using drinking water as the raw material, through pre-treatment and the "secondary reverse osmosis" water production process, and then transported to the extraction workshop for use. At the same time, it also describes that the system's design, manufacturing, installation, debugging, and final acceptance meet the relevant requirements of Chinese GMP.
2 design standards
2.1 Equipment Standards
Implementation Regulations of the Drug Administration Law of the People's Republic of China
China GMP2015 Edition
The Chinese Pharmacopoeia 2015 edition, Part II, page 411, Appendix XVI
2.2 Industry Standards
ISPE (Society of Pharmaceutical Engineers) Drug Production Automation Management Specification ® 5- Guidelines for Validation of Drug Production Automation Systems
JB 20067-2005 "General Principles for Compliance of Pharmaceutical Machinery with Good Manufacturing Practice for Drugs"
JB/T 20091-2007 "Guidelines for Validation of Pharmaceutical Machinery (Equipment)"
2.3 National Standards
GB/Z1-2010 "Hygienic Standards for the Design of Industrial Enterprises"
GB/T15706 (1.2) -2007 "Basic Concepts and Design Principles for Mechanical Safety"
GB23821-2009 "Safety Distance for Preventing Upper and Lower Limbs from Touching Dangerous Areas in Mechanical Safety"
GB8196-2003 Safety Standard for Mechanical Equipment Protective Cover
GB5226.1-2008 "Mechanical Electrical Safety - Mechanical Electrical Equipment" Part 1: General Technical Conditions
GBT9969-2008 General Principles for Industrial Product User Manual