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Requirements for water purification systems for biopharmaceuticals
Publisher: Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd Time：2023-03-07 15:14:46 Number of clicks：328 Close

Biopharmaceutical experimentation is the further processing of raw materials into medical drugs. These raw materials -- including active pharmaceutical ingredients (apis) and other related excipients -- are subjected to rigorous testing to identify potential impurities of any kind. In the process of quality control, drug products need to be tested for impurities of the desired kind. Raw materials and pharmaceutical products shall not contain any impurities and contaminants. Drug products are tested before they are put on the market.


Pharmaceutical laboratories carry out various quality control tests to find impurities in them. These tests include:
Liquid chromatograph
Molecular biology technique
Cell culture
Toxicity analysis
Microbiological test
Sterility test
Antibacterial effect
Endotoxin test
Monitor and identify validation
Sterilization verification
Biological load analysis
Usually these tests require pure water. Only pure water in accordance with relevant regulations can ensure the accuracy of test results. All GMP preparation is also done with the help of water. Only the quality assurance, verifiable laboratory pure water system, to meet the biopharmaceutical process required to obtain pure water, to obtain good experimental results.
Pure water solutions and applications in biopharmaceuticals


Pure water systems are used to provide pure water for a variety of applications in biopharmaceuticals. Here are some pure water solutions in biopharmaceuticals and where they can be used:
In the testing of raw materials and pharmaceutical products
Water is an excellent solvent. It can dissolve many substances. A lot of biopharmaceutical processes need to be dissolved in pure water for reaction. The impurity detection of raw materials and other auxiliary materials related to the experiment usually needs to be dissolved in pure water. Therefore, pure water that meets the test requirements must be used. Only when the pollutants in pure water are controlled, can successful test results be guaranteed.
In order to ensure good results in biopharmaceutical experiments, a reliable laboratory water system should be used. There are many things to be aware of before purchasing and installing a laboratory water supply. Rigorous testing processes require the use of high quality water. In addition, it is necessary to understand the parameters of pure water required for biopharmaceutical experiments and testing processes. This helps in the laboratory testing process of raw materials and pharmaceutical products.
Comply with GMP standard

In every drug development process, quality control is required. These quality testing protocols must be defined by GMP regulations in accordance with which biopharmaceutical products in laboratories can be tested. These GMP regulations also require the use of reliable and verifiable pure water.


GMP regulations are established by the relevant regulatory authorities to test the quality of biopharmaceutical products. The most recent approach is called the cGMP regulations. cGMP regulations assure all consumers that biopharmaceutical products are reliable and repeatable. Pure water is an important part of the relevant quality testing procedures in cGMP regulations. Water quality testing applications are as follows:
sampling
filtration
Cell culture
Buffer preparation
Biopharmaceutical equipment cleaning
Tap water has a wide variety of impurities that can negatively affect the quality testing process, which can hinder biopharmaceutical processes and the approval of pharmaceutical products. Therefore, pure water must be used to comply with cGMP regulations. In biopharmaceutical laboratories, maintaining consistency in pure water quality can yield more positive results and ensure compliance with GMP. Biopharmaceuticals need to select a perfect laboratory pure water system, which can not only produce pure water that meets the requirements of pharmacopoeia and standards, but also must be able to carry out verification, especially for FDA related verification, English verification documents are necessary.

Requirements for water purification systems for biopharmaceuticals


The pure water system of biopharmaceutical working laboratory should meet the requirements of GMP regulations. Laboratory pure water systems should be able to produce Level 1 ultrapure water for all test procedures. Ultrapure water should have good resistivity, low total organic carbon (TOC) and low microbial and endotoxin levels.
In the use of laboratory pure water system, the pure water system should be maintained regularly to produce ultra-pure water. This will ensure the reliability of pure water in biopharmaceuticals.
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