In life science laboratories, numerous experiments must be conducted, and pure water is essential for nearly every type of experiment. Additionally, pure water plays a significant role in the biopharmaceutical field, which is increasingly utilized in therapeutic procedures.
Biopharmaceuticals are medical drugs or products produced through biotechnological processes. These products can include proteins or nucleic acids, such as RNA, DNA, oligonucleotides, and antibodies. To produce these biopharmaceuticals, researchers require pure water at every stage of the process. This water must be free of impurities, particularly bacteria, pyrogens, RNases, and DNases, as their presence can significantly affect biological experiments and alter the results of biopharmaceuticals. Laboratory pure water systems must possess robust technical characteristics to consistently generate pure water that meets stringent quality standards. In the biopharmaceutical manufacturing process, quality control tests must be conducted in accordance with the requirements set forth by regulatory agencies at each stage, ranging from simple chemical analyses to determine the characteristics and quality of biopharmaceutical products to more complex procedures. All of these processes and experiments necessitate the use of pure water.
Biopharmaceuticals are raw materials that undergo further processing to become medical drugs. These raw materials, which include active pharmaceutical ingredients (APIs) and other related excipients, are rigorously tested to identify potential impurities. During the quality control process, drug products are evaluated for the required types of impurities. Both raw materials and drug products must be free from any impurities and contaminants. Drug products are tested before they are released to the market.
Demand for Purified Water in Biopharmaceutical Processes
Pharmaceutical laboratories conduct a range of quality inspection tests to identify impurities. These tests include:
Liquid chromatography
Molecular biology techniques
Cell culture
Toxicity analysis
Microbiological testing
Sterility testing
Antibacterial efficacy
Endotoxin testing
Monitoring and identification validation
Sterilization validation
Bioburden analysis
Usually, these testing processes require purified water. Only purified water that meets relevant regulations can ensure the accuracy of test results. All Good Manufacturing Practice (GMP) preparations are also conducted using water. A quality-assured, verifiable laboratory water purification system is essential to obtain the pure water necessary for biopharmaceutical processes and to achieve reliable experimental results.
Pure Water Solutions and Their Applications in Biopharmaceuticals
Pure water systems are utilized to supply high-quality water for various applications in the biopharmaceutical industry. Below are some pure water solutions and their applications in biopharmaceuticals:
In the testing of raw materials and pharmaceutical products
Water is an exceptional solvent capable of dissolving a wide range of substances. In the biopharmaceutical process, numerous components must be dissolved in pure water to facilitate reactions. Raw materials and various excipients related to the experiment are typically dissolved in pure water for impurity testing. Consequently, it is essential to use pure water that meets specific testing requirements. Successful test results can only be assured when contaminants in the pure water are effectively controlled.
In order to achieve optimal results in biopharmaceutical experiments, it is essential to utilize a reliable laboratory pure water system. Before purchasing and installing such a system, several factors must be considered. Strict testing processes require high-quality water. Additionally, it is important to understand the specific purity parameters needed for biopharmaceutical experiments and testing procedures. This knowledge aids the laboratory in accurately testing raw materials and drug products.
GMP Compliance
Quality control is essential in every drug development process. The quality testing protocols are defined by GMP regulations, and biopharmaceutical products must be tested in the laboratory in compliance with these standards. Additionally, GMP regulations mandate the use of reliable and verifiable pure water.
GMP regulations are established by relevant regulatory agencies to ensure the quality of biopharmaceutical products. The most current standards are referred to as current Good Manufacturing Practice (cGMP) regulations. cGMP regulations ensure the reliability and reproducibility of biopharmaceutical products for all consumers. Pure water plays a crucial role in the quality testing procedures outlined in cGMP regulations. The applications of water quality testing include the following:
Sampling
Filtration
Cell culture
Buffer preparation
Biopharmaceutical equipment cleaning
Tap water contains numerous impurities that can adversely impact the quality testing process, potentially hindering the approval of biopharmaceutical processes and drug products. Therefore, it is essential to use pure water to comply with cGMP regulations. In biopharmaceutical laboratories, maintaining consistent pure water quality can yield more reliable results and ensure adherence to GMP standards. Biopharmaceutical companies must select a comprehensive laboratory pure water system that not only produces water meeting pharmacopoeial requirements and standards but is also verifiable, particularly for FDA-related verification, which necessitates English documentation.
Requirements for Water Purification Systems in Biopharmaceuticals
The pure water system in the laboratory for biopharmaceutical work must comply with Good Manufacturing Practice (GMP) regulations. This system should be capable of producing Class 1 ultrapure water for all testing procedures. Ultrapure water must exhibit high resistivity, low total organic carbon (TOC) content, minimal microorganisms, and low endotoxin levels.
In laboratory pure water systems, regular maintenance is essential to produce ultrapure water. This practice ensures the reliability of pure water in biopharmaceutical applications.
Conclusion
Pure water plays a crucial role in biopharmaceutical laboratories. It serves as a vital reagent and is necessary for various steps in quality control procedures. Researchers and scientists utilize laboratory water purification systems to obtain ultrapure water. Reliable and verifiable pure water solutions are essential at all stages of biopharmaceutical quality control.
RephiLe Bioscience, a subsidiary of Duoning Group, is a high-tech enterprise specializing in the research, development, and manufacturing of water purification and laboratory separation and purification products. The company employs international operational management practices, positioning its products as high-tech and of superior quality, driven by innovation and focused on customer service. RephiLe Bioscience has established its own brand, holds independent intellectual property rights, and has formed collaborative relationships with several high-tech institutions both domestically and internationally. Additionally, the company has developed a global marketing network, and its products are currently sold in nearly 100 countries across Europe and the United States.
Super-Genie Smart High-Flow Pure Water Workstation
Super-Genie Smart High-Flow Pure Water Workstation utilizes tap water as its source to produce pure and ultra-pure water, achieving a daily output of up to 14,000 liters. The Super-Genie is capable of monitoring the entire pure water system and pipeline operations through its central host, ensuring stable and reliable water production. It is currently one of the most highly integrated laboratory pure water workstations available on the market.
Genie Smart Pure Water System
The Genie Smart Pure Water System utilizes wireless technology to establish a connection between the host, main control screen, and handle as needed. The main control screen features a highly sensitive 8-inch touch screen that can be operated with either water or latex gloves. It includes intelligent identification codes for consumables and parts, ensuring full traceability, real-time feedback, and remote monitoring.
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