Quality Control - Oriented Process Analysis and Practice of Pure Water Engineering in Biopharmaceutical Workshops
创建于06.11
Abstract: This paper focuses on the pure water engineering in biopharmaceutical workshops, deeply analyzing its process flow and quality control points from a scientific research perspective. Relying on the practice of Guangzhou Cleanroom Construction Co., Ltd., it elaborates on the impact of each unit operation on the quality of pure water, providing theoretical and practical references for the construction and optimization of pure water systems in the biopharmaceutical industry.
1. Introduction
In biopharmaceutical production, pure water, as a crucial production factor, directly relates to the safety, effectiveness, and stability of pharmaceuticals. The pure water engineering in biopharmaceutical workshops needs to accurately remove pollutants such as impurities, microorganisms, and pyrogens, meeting strict standards like the "Chinese Pharmacopoeia". Guangzhou Cleanroom Construction Co., Ltd. has been deeply engaged in the biopharmaceutical purification field. Through full - process quality control of pure water engineering, it ensures the safety of pharmaceutical water and contributes to the high - quality development of the industry.
2. Process Flow and Principles of Pure Water Engineering in Biopharmaceutical Workshops
(2.1) Pretreatment Unit
1. Process: Tap Water → Raw Water Tank → Raw Water Pump → Quartz Sand Filter → Activated Carbon Filter → Security Filter
2. Principles and Functions
1. Raw Water Buffering and Conveying: Tap water first flows into the raw water tank. The raw water tank, like a "stabilizer", plays a role in buffering and homogenizing water quality. It can balance the fluctuations of inlet water pressure, making the inlet water quality for subsequent treatment links more stable. The raw water pump provides power for the water flow, just like a "power engine", pushing the water into the subsequent pretreatment links to ensure the smooth circulation of water.
2. Quartz Sand Filtration: The quartz sand filter uses the interception and adsorption characteristics of quartz sand particles to treat raw water. Large - particle suspended impurities such as sediment and rust in the water will be intercepted and adsorbed by the quartz sand particles, thereby reducing the turbidity of the water. This step is like "preliminarily washing the face" of the raw water, removing the large - particle "dirt" first and reducing the burden on subsequent membrane treatment equipment.
3. Activated Carbon Adsorption: The activated carbon filter exerts an adsorption effect by virtue of the porous structure and surface functional groups of activated carbon. Pollutants such as organic matter and residual chlorine in the water will be "captured" by activated carbon. If residual chlorine enters the subsequent reverse osmosis system, it will oxidize the membrane elements, while activated carbon can adsorb and degrade residual chlorine, playing a role in protecting the membrane elements; at the same time, it can also remove some soluble organic matter and further improve water quality, which is equivalent to "deep cleaning" the raw water.
4. Security Filtration Check: The security filter, as the terminal "goalkeeper" of pretreatment, is equipped with a high - precision filter element (usually 5μm). It will intercept the fine particles that leak through in the previous links, preventing these particles from entering the reverse osmosis system, avoiding the scratching and blocking of membrane elements, and ensuring the stable operation of the subsequent reverse osmosis system.
(2.2) Reverse Osmosis Unit
1. Process: Security Filter → Primary High - Pressure Pump → Primary Reverse Osmosis → Secondary High - Pressure Pump → Secondary Reverse Osmosis → RO Water Tank
2. Principles and Functions
1. Reverse Osmosis Desalination and Purification: The operation of reverse osmosis (RO) is based on the principle of a semi - permeable membrane. Driven by the pressure provided by the primary and secondary high - pressure pumps, water, as a solvent, will permeate through the semi - permeable membrane, while solutes such as salts and macromolecular organic matter are intercepted. The primary reverse osmosis can remove more than 90% of dissolved solids, organic matter, and microorganisms, just like "preliminarily refining" the water flow. The secondary reverse osmosis further deeply removes salts and impurities on this basis, making the purity of the effluent higher and meeting the strict requirements of biopharmaceuticals for low salt content and low microbial load, which is equivalent to "secondary purification".
2. RO Water Tank for Water Storage and Buffering: The RO water tank is used to store the water produced by reverse osmosis. It is like a "reservoir", providing stable water supply for subsequent deep - treatment links and water - using points. At the same time, using its own volume, it can buffer the fluctuations of water consumption, ensuring the continuous operation of the entire pure water system and avoiding problems caused by sudden changes in water consumption.
(2.3) EDI Deep - Treatment Unit
1. Process: RO Water Tank → EDI Booster Pump → Ultraviolet Sterilizer → EDI Device → EDI Purified Water Tank
2. Principles and Functions
1. Synergistic Effect of EDI Technology: EDI (Electrodeionization) integrates ion exchange and electrodialysis technologies. Under the action of a direct - current electric field, ions in the water will migrate through the ion - exchange membrane. Through the adsorption - desorption of resin and the electromigration process, continuous desalination is achieved. The EDI booster pump ensures the stable pressure of the water flow entering the EDI device, just like a "pressure regulator". The ultraviolet sterilizer inactivates microorganisms in advance, reducing the possibility of microbial growth in the EDI and subsequent systems, playing a role of "pre - sterilization".
2. Preparation of High - Purity Water: The EDI device can further purify the reverse - osmosis produced water, enabling the resistivity of the effluent to reach about 18.2MΩ·cm (25℃), close to the theoretical value of pure water. It effectively removes residual ions, meeting the requirements of biopharmaceuticals for high - purity water. For example, the production of injections requires pure water with extremely low impurity content, and the EDI device is like an "ultimate purification master". The EDI purified water tank is used to store high - purity produced water, providing high - quality pure water for water - using points accurately.
(2.4) Water Supply and Circulation Unit
1. Process: EDI Purified Water Tank → Purified Water Supply Pump → Ultraviolet Sterilizer → Water - Using Points → Return Water System → EDI Purified Water Tank
2. Principles and Functions
1. Pure Water Conveying and Re - Sterilization: The purified water supply pump provides power for the conveyance of pure water, just like a "water - conveying power source", ensuring that the water flow can reach the water - using points stably. Stations such as liquid preparation and cleaning all require a stable supply of pure water. The ultraviolet sterilizer exerts a sterilization effect again at the water supply end, preventing the growth of microorganisms during the water supply process and maintaining the sterile state of pure water. This is like "the last sterilization insurance" for pure water.
2. Circulation to Ensure Water Quality: The return water system constructs a circulation pipeline, allowing the unused pure water to flow back to the EDI purified water tank, keeping the water in the system in a dynamic circulation. On one hand, it avoids the generation of stagnant water, because stagnant water is prone to microbial growth; on the other hand, it can also use the heat of circulation to maintain a stable water temperature, ensuring the uniformity of water quality. This is in line with the continuous and high - precision production requirements of biopharmaceuticals, making the entire pure water system a "dynamic clean circulation body".
3. Quality Control Points and Practices of Guangzhou Cleanroom Construction Co., Ltd.
(3.1) Quality Control of the Pretreatment Unit
Guangzhou Cleanroom Construction Co., Ltd. regularly monitors the water quality of the inlet and outlet water of the quartz sand and activated carbon filters, focusing on indicators such as turbidity, residual chlorine, and organic matter content. At the same time, it formulates the replacement cycle of filter elements and the backwashing cycle of filter materials. In case of fluctuations in raw water quality, such as an increase in the turbidity of raw water in the rainy season, it will dynamically adjust the parameters of the pretreatment to ensure the stability of the water quality entering the reverse osmosis system, just like ensuring the quality of the "beginning" of the entire pure water project.
(3.2) Quality Control of the Reverse Osmosis Unit
For the reverse - osmosis membrane elements, periodic detection will be carried out, with the membrane flux and desalination rate as the key detection indicators. A combination of online monitoring and offline detection is adopted. When the membrane flux decreases by 10% or the desalination rate decreases by 5%, the membrane elements will be cleaned, maintained, or replaced in a timely manner. It will also optimize the operating parameters such as the pressure of the high - pressure pump and the recovery rate, finding a balance between the quality of produced water and energy consumption, and ensuring the long - term and efficient operation of the reverse - osmosis system, so that this "pure water refining station" can always work stably.
(3.3) Quality Control of the EDI Deep - Treatment Unit
It monitors parameters such as the resistivity, pressure, and flow rate of the inlet and outlet water of the EDI device in real - time, establishing an early - warning mechanism. The EDI resin will be activated and regenerated regularly to ensure the efficiency of ion exchange. At the same time, combined with the monitoring of the operation time and irradiation intensity of the ultraviolet sterilizer, the microbial inactivation effect is ensured, providing a guarantee for the production of high - purity pure water and ensuring that the "ultimate purification link" has no errors.
(3.4) Quality Control of the Water Supply and Circulation Unit
An online water quality monitoring system is constructed, and indicators such as microorganisms, resistivity, and endotoxins are detected in real - time at the water - using points and the return water end. The circulation pipeline will be disinfected and cleaned regularly, and the roughness and material compatibility of the pipeline will be controlled to avoid secondary pollution of water quality by the pipeline. By optimizing the frequency of the water supply pump and the circulation flow, the stable operation of the system is maintained, and the continuous compliance of the water quality at the water - using points is ensured, so that the supply of pure water in the "last kilometer" can also be of high quality.
4. Conclusion
The pure water engineering in biopharmaceutical workshops is a complex system project, and its process flow design and quality control need to be closely centered on the pharmaceutical water standards. Guangzhou Cleanroom Construction Co., Ltd. achieves the high - quality production of pure water for biopharmaceuticals through precise control of each unit operation and full - process quality supervision. In the future, with the iteration of biopharmaceutical technology, pure water engineering needs to further develop towards intelligence and refinement, continuously improving the water quality guarantee capability, providing a more solid support for the safety of drug quality, and promoting the biopharmaceutical industry to reach a new height.
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