The Water Purification In Biopharmaceuticals

In a laboratory, there are thousands of experiments lined up for execution. These experiments range from small sample solutions to large DNA tests and cycles. Almost every type of lab experiment needs pure water for making samples or testing any fragment of DNA. A major application of pure water is the biopharmaceutical area, which is famous for its use in the therapeutic process. In simple words, biopharmaceuticals are medical drugs or products which are produced with the biotechnology process. The drugs can be proteins, nucleic acids(RNA, DNA, oligonucleotides, antibodies, etc.

For producing such products, the researchers need lab water in each step. And this pure water should be free of any kind of impurities. No contaminant should be there, as the presence of it will alter the biopharmaceutical results in the lab. The laboratory water purifier should be of good technology so that pure water can be obtained consistently.  In biopharmaceutical processes, quality control testing is done in every part according to the World Health Organization policy. All processes can range from simple chemical experiments which determine the identity and quality of the biopharmaceutical products, to more complex processes. All these processes or experiments need water for performance in a laboratory. Some pharmaceutical experiments need simple procedures and some complex substances like pharmacopeial monographs. 

Need Of Pure Water In Biopharmaceuticals Processes

Biopharmaceuticals experiments include raw materials, which are further processed to make a medical drug. These raw materials, including active pharmaceutical ingredients (API) and other related excipients, are rigorously tested with pure water in search of any kind of impurity. The pure water is obtained by a  water purification system for laboratory at any hour of the day. All impurities should be eliminated first from the raw materials before the execution of the experiment. In the process of quality control,  the finished medical drug is all tested for any kind of impurity. Both raw materials and finished products should not have any impurity or contamination.  The finished product is tested before its distribution in the market. 

Various quality check tests are conducted in the pharma laboratories to test any impurities in it. Some are as follows:

All these tests or  processes require pure water for execution. All GMP compilations are also done with the help of water. The water distillation unit for laboratory is installed to obtain pure water for all biopharmaceutical processes. It is important to test the materials with pure water to get good results.  Water purification is the key source of obtaining pure water.

Water Purification Solutions Or Areas In Biopharmaceuticals

As mentioned in the above paragraphs, biopharmaceutical processes use pure water for every purpose of lab testing. The water purification systems for laboratory are used to get the pure water for various applications of biopharmaceuticals.  As a researcher, you can also check a water purification system price online before settling for a purification system.

Following are some of the water purification solutions or areas in biopharmaceuticals :

1.  In Rigorous Testing Of Raw Materials And Finished Products

Water is called an excellent solvent, as it dissolves any kind of substance in it.  Biopharmaceutical processes are full of such applications of pure water from a lab water system. The raw materials and other excipients related to the experiment are rigorously tested for any kind of impurity using pure water.  Thus, water purification is a must in this direction.  The water used to test should be free of contaminants to get successful results. 

To get good results out of the biopharmaceuticals experiments, a laboratory water purifier was used. This purifier is installed to get a consistent water supply. A lot should be studied before installing a lab water system.  The rigorous testing is done with water and it should be ideal for it.  Also, know about the type of water you need for the biopharmaceutical experiments and testing process. This all would help in the testing process of raw materials and finished products in the laboratory. Some water purification systems for laboratory provide such options for types of water. So,  you can always choose the type of lab water you need.

2.  In Compilation With GMP Regulation

In every pharmaceutical drug development process, the quality is being tested. All these testing protocols are defined by the GMP regulations. The biopharmaceutical products in the quality control laboratories have to undergo GMP regulations to be tested.   For these purposes also, pure water is used. The GMP regulations are compiled by the Food and Drug Administration(FDA) for testing the quality of biopharmaceutical products. The recent practices are called cGMP regulations. The FDA units periodically make changes in the GMP regulations to establish strong quality management.

With the aims of cGMP regulations, it assures all its consumers about its reliability and reproducibility. Water is a crucial part of any quality testing procedure. Pure water is needed to test the quality of materials from a water purification system for laboratory use. The quality testing applications of water is as follows:

  • Sampling
  • Filtration
  • Cell culturing
  • Buffer Preparation
  • Rinsing of Equipment of biopharmaceuticals

The tap water is full of many kinds of impurities which would negatively impact the quality tests.  So, it is necessary to pretreat the water for good quality testing procedures.  All kinds of quality analysis tests can be done with pure water obtained through a lab water purification system. Further, tap water can also distort the impurities in the water, which would block the processes of biopharmaceuticals and in approval of the drug product.

When in the biopharmaceutical laboratories, the pure water quality consistency is maintained, it produces more positive results as per GMP regulations. In the presence of pure water, the likelihood of getting more compliance with GMP is higher.  All testing of products and procedures of biopharmaceuticals require water which starts with selecting a perfect laboratory water purification system. The water system should be able to produce water for the processes of quality tests.  With pure water, GMP regulations can be maintained and validated.

The Requirements Of Water Purification System In Biopharmaceuticals

A water purification system for laboratory in a biopharmaceutical work should meet all requirements of GMP regulations. The lab water purification system should be able to produce type I (Ultrapure Water)  for all testing procedures.  Pure water obtained through a lab water system should have good resistivity, low total carbon content(TOC), and low microbiological entities. Low levels of endotoxins are also evaluated in the water. 

Further, in the selection of water purification systems in the laboratory, pharmaceutical quality testing should be performed with water analysis. The water system should be maintained regularly to produce ultrapure water.  This would ensure the reliable production of pure water in biopharmaceuticals. As a researcher or scientist, you have to consider water purification technology also.  The technology also works in this direction of producing ultrapure water from a water distillation unit for laboratories.


Water Purification plays a major role in biopharmaceutical laboratories.  As water is the most important reagent of all, it is needed in all steps of quality control procedures. Researchers and scientists use water purification systems for laboratories to obtain ultrapure water. The above-mentioned water purification solutions are effective in all phases of quality control in biopharmaceuticals.

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