Why Water filtration process is used in pharma industries?
The water filtration process is the process by which undesired chemical compounds, organic and inorganic materials, and biological contaminants are removed from the water. A number of methods and processes are adopted to filter pure water out of the incoming pure water. One of the major uses of the water filtration process is for drinking water. Apart from drinking water, another major consumer of pure water is industries.
Modern industrial and manufacturing processes use water for virtually every process. A prominent use is found in the pharmaceutical product manufacturing sectors. Pharmaceutical product manufacturers employ water filtration processes in their pure water systems to produce pure water for use in the manufacturing process.
Pure water is used for formulation, mixing and is an important ingredient in the medicine and medical device manufacturing market. This water, however, is monitored by strict quality guidelines of USPA and European Pharmacopeia.
What is a shell and tube heat exchanger
A heat exchanger is a device that transfers heat from one fluid to another. A heat exchanger is an essential piece of equipment for the smooth working of many modern machines The most common use of a heat exchanger is in a refrigerator. While all heat exchangers work on the same principle, there are a number of different designs for it. Each heat exchanger is designed to achieve efficient transfer of heat in its respective applications.
One of the vital uses of a heat exchanger is of a shell and tube heat exchanger in a pure water system. A shell and tube heat exchanger, as the name suggests, contains multiple tubes encased in a shell. These shells and tubes are made of thermally conductive materials that allow easy transfer of heat. The tubes carry fluid from their inlet and out from the outlet while the shell passes a separate fluid over these tubes.
The number of tubes dictates how much surface area is exposed to the fluid flowing within the shell. TSA water systems provides shell and tube heat exchanger that are compact, easy to operate at the same time provide excellent heat transfer.
Purified Water Systems in Pharmaceuticals
Pure water systems are employed in pharmaceutical industries to produce high purity water. This water is used as a solvent and ingredient for formulation in multiple pharmaceutical processes. As such this water for pharmaceutical use should meet the standard quality for purified water. Pure water plants utilize a number of techniques and methods to purify water.
One of them is an RO system. RO or reverse osmosis is the process of purifying water by way of reversing the natural osmotic flow of water. This helps the water for pharmaceutical use to be free from bacteria and other impurities. This method is one of the most trusted methods to purify water in pharmaceutical industries.
Pharmaceutical manufacturers need to ensure that the pure water used in their processes is up to the mark and is compliant with various standards set by national and international agencies. A system producing pure water for pharmaceutical use should be designed keeping in mind the quality of the end product.
Water quality specifications for a water system validation
A pure water system is one of the most sensitive units in a manufacturing plant. This holds especially true for pure water systems in pharmaceutical drugs and medical device manufacturing industries. Hence, an efficiently designed pure water system will pass all the required water system validation required by the agencies. Below are some major water quality specifications that a pure water system needs to adhere to –
- Total Organic Carbon (TOC) level – TOC is the total amount of organic content in the pure water system. This is the ultimate microbial test in the water system validation in the pharmaceutical manufacturing industry. A high purity water system will have a TOC monitor on site to facilitate accurate and fast measurement of TOC levels in the water.
- Conductivity or Resistivity – Purified water has very low levels of conductivity, especially if it is produced in systems utilizing deionization methods. In addition to a conductivity meter, water system validation guidelines stipulate the installation of a resistivity meter to accurately effect the measurement of water purity levels.
- Microbial testing – Microbial testing is performed on a system to check for presence of bacteria and endotoxins. Growth of bacteria and other endotoxins is impeded greatly by the design of a water purification system. An efficient water system validation process ensures that the water purification unit passes all the required microbial testing.
An overview of shell and tube heat exchangers
A shell and tube heat exchanger is used in industries to efficiently transfer heat from one medium to another without having them make contact with each other. This is achieved via a cylindrical shell with a bundle of tubes inside them. The tubes are made of heat conductive materials and allow heat exchange between the hot liquid flowing outside the tubes and the cool liquid flowing through the tubes.
They are employed in most modern industries that require removal of process, cooling of hydraulic and oil, condensing vapour or steam or even evaporating liquid or steam, and most importantly pre-heating feed water. Pharmaceutical manufacturers employ shell and heat tube exchanger for exactly purpose, preheating of feed water. This ensures that the feed water is pre-treated before being used in any water purification system.
They are easily dismantled; this means maintenance is relatively easier than other heat exchangers. A shell and tube heat exchanger is compact in size and its capacity can be increased as per the requirements of the manufacturer.
Quality of water for pharma use
Water is one of the most widely used resources in the manufacturing industry. It is used in virtually every industry, sometimes as a raw material, sometimes as a cleaning agent, sometimes even as a carrier of materials around the production line. Naturally, there are different types or grades of water that are used classified as per their purity levels. Pharmaceutical manufacturing utilizes the most high purity level of water.
Water for pharmaceutical use is from formulation, processing, mixing and also as a cleaning agent for equipment and systems. Pharmaceutical manufacturers produce high purity water with the help of pure water systems. Pure water systems employ different techniques or methods to purify water as per the required outcome. A higher water purity level requires more intensive method of purifying water. This makes production of water for pharmaceutical use a resource and design intensive task.
The systems need to be designed in compliance with the standards set by various national and international agencies. TSA water systems is a market leader in manufacturing systems that produce water for pharmaceutical use. Our designs are optimises to maximise purity and minimise wastage.
A brief introduction on Water for injection
Water is an essential ingredient used in the Pharmaceutical industry whether as it is used as solvent, carrier, ingredient, excipient or just used to clean the equipment. It is essential across all the different stages of manufacturing and maintenance in the pharmaceutical industry.
Water for Injection is a specific type of water, held to higher standards of purity and safety as it is to be used in injectibles as a solvent or a carrier. Wfi water is primarily distilled, sterile and pyrogen-free which are fever inducing micro-organisms. It is also prepared according to USP Monographs and local drug manufacturing regulations.
The uses of Wfi water include preparation of parentals or injectable formulations and for cleaning of ampoules which are containers that hold the injectables. Since the water is held to higher standards it must undergo several tests for purity such as pyrogen test and tests for endotoxins and particulate matter. It is also produced by using processes such as distillation, reverse osmosis and membrane process.
