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Purified Water Is Key in Pharmaceutical Quality Control Testing

Date 21 November 2022

Purified water is one of the important reagents used in the pharmaceutical industry.  The water may be present as an excipient or can be used for reconstituting with various products, during the synthesis of medical drugs in a pharma lab. The finished product by the synthetic lab can also include water in it. Purified water plays a major role in the pharmaceutical quality control testing process by accompanying the products at every level. There are several applications of pure water in a pharma laboratory that uses water, such as rinsing the instruments and equipment, primary packing of products, etc.  For all these purposes, the lab fellow needs different grade water. The different grade of water is supplied through a laboratory water purifier, installed in a lab.

In pharmaceutical quality testing procedures, the lab water is differentiated into the following types:

  • Bulk Water: This kind of water is produced on the site of need in bulk amount.
  • Packaged Water: This kind of water is used for packing and sterilizing the products to preserve microbial quality to improve the shelf life.

The above-mentioned water used in pharmaceutical quality testing has specific uses, quality attributes, and acceptable methods of preparation. Further, Type I, Type II, Type III pure water is also used for the quality testing procedures in a pharma lab.  The use of pure water from various water purification systems for laboratory depends on the need of the experiment. The major quality testing need is for microbial growth. A healthy microbial growth should be maintained in the finished product, to prolong the shelf life. This application of quality testing needs more use of purified water in a laboratory.

Pharmaceutical Quality Control Testing

Pharmaceutical quality control testing procedures are essential to any pharma lab. The industry follows the testing procedures to make sure the medicines are safe to use. Further, quality testing is done to see whether the medicines are performing therapeutically well or not. According to the World Health Organisation, these testing procedures can range from simple chemical experiments to complex ones. All these experiments are performed with the help of purified water obtained from a water purification system for laboratory.

The testing procedures also pay attention to the determination of a pharmaceutical‘s chemical identity with the help of thin-layer chromatography,  and infrared spectroscopy.  The raw materials include active pharmaceuticals ingredients(APIs), and excipients must be treated with purified water from a lab water purification system during the quality testing.  The finished product is also tested in this manner, to ensure the shelf life and further, make the product more reliable to use.

Need Of Purified Water For Pharmaceutical Quality Control Testing Procedures

Purified water finds its use in a variety of pharma applications. The Purity of water is a very necessary component in performing the testing procedures.  Tap water or normal water contains many impurities that can alter the testing results. Thus, it is recommended to purify the water in a water distillation unit for laboratory, for obtaining pure water. The lab water or pure water does not contain any impurities, that help in various procedures of quality testing.

The installation of water purification systems for laboratory is useful in all regards. As a researcher, you can also check a water purification system for laboratory price online or in the offline market. Following are some areas, where purified water is used for the testing process:

1.  In Neoparenteral Preparations In Pharmaceutical Applications

Neoparenteral preparations are the major application of the pharmaceutical lab. In these preparations, the purified water is needed in ample amount to clean the involved equipment,  and in some components. In addition to all these, the purified water is also used for different types of tests and assays in a pharma lab. The experiment where the use of purified water is indicated must be used with strict guidelines. No impurity should be there in the water when it is used for the neoparenteral preparations in the lab.

The purified water or lab water used in this purpose of the pharma lab should meet all kinds of requirements of the experiment.  The chemical purity of water obtained from a laboratory water purifier should also be considered.  And further, the water used in experiments should be protected from microbial contamination so that the water can remain useful for a longer time. To ensure a good outcome of the pharmaceutical quality control testing procedures, a researcher should install a reliable water purification system for laboratory. The lab water system should be consisting of validated water purification technology like activated carbon technology, ion-exchange method, electrodeionization, reverse osmosis, etc.  Also to obtain the best quality control results, install the water purification system for laboratory use in ambient conditions, and protect it from microbiological biofilms production. These biofilms can destroy the purity of water and further hinder the quality test procedures in the pharma lab.

2. In Analytical Methods For Detecting Impurities In Finished Products And Raw Materials

In recent years,  the pharma industry has accelerated its medicine production. With this, the need for analytical testing methods is also devised.  To test, a large number of medicinal products is the current hour need. And for this, pure water is needed to detect the impurities in the raw materials as well as in finished products. Some analytical methods are used in this quality testing method. These methods can be highly sophisticated and developed for the monitoring and control of pharma product purity or quality. The most important analytical method is liquid chromatography, mass spectrometry. These methods use pure water to give out good results. A lab water system produces the kind of pure water, one needs for their experiment in a pharma lab.

These analytical methods for testing include a range of microbiological tests and other toxicological tests. Other tests are also there where purified water from a water purification system for laboratory use is included. These tests are molecular biology techniques, cell culture methods, chromatography methods, etc. All such techniques remove impurities from the raw materials and finished products in a pharma lab. The sterility tests are also done in the quality testing procedure for the testing efficiency of the products. To perform such tests, purified water is required in abundance from a lab water system in a highly pure state.

Purified Water Assuring Pharma Lab Quality

Almost all quality control testing laboratories. This assure that the researchers are using purified water obtained from a water distillation unit for laboratory. They assure this by performing quality testing water analysis regularly.  It is believed that the water production in a pharma lab, should be designed very intricately by considering all its components. The installation of a lab water purification system should be done very carefully to obtain a consistent water supply for experiments.

Reliable water quality is obtained by a lab water system to be used in all kinds of pharma quality testing procedures. These quality testing laboratories also make sure that they are only using the appropriate pure water.  All quality control testing tests or procedures are performed by using ultrapure water(type I)  to avoid any kind of contamination. Here ultrapure water is used for the highly sensitive endotoxin-laden analysis in a lab. While type II water can be used for general analysis and microbiological analysis.

 

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