Water Treatment for Pharmaceuticals Industries
Pharmaceutical water purification systems are crucial to every phase of pharmaceutical operations, from research and development through the production of pharmaceutical goods. The pharmaceutical sector is one of the most strictly controlled, and each step of the manufacturing process for pharmaceuticals must be meticulously monitored and filtered to avoid product contamination.
Purified water is one of the main components used in the production of medicines and other active substances in the pharmaceutical industry. Water can be used for cleaning, synthesis, reconstitution of materials, and the creation of finished goods. The many water grades required for pharmaceutical manufacture are described in the USP monographs, along with appropriate techniques to create them.
There are different grades of water depending upon the application in pharmaceutical manufacturing. However, it is similar to the criticality of the process upon which different classes of clean room are based.
Purified Water Generation Plant
Purified water is used in the preparation of all medication containing water except ampoules, injections, some official external preparations such as liniments. Purified Water must meet the requirements for ionic and organic chemical purity and must be protected from microbial contamination.
APK designed Purified Water Generation Plant in Chemical Sanitisable & Hot Water Sanitisable as per customer requirement and end use. APK design Purified Water Generation Plant that has undergone various purification steps, including physical and chemical processes like filtration, ion exchange (IEX), and RO, to remove impurities, UF, EDI, UV for high Purified water.
- Pretreatment
Multimedia Filters: Multimedia filters efficiently remove suspended impurities and turbidity from water. They consist of carefully graded sand layers, offering a reliable way to maintain water clarity. APK supplied MMF in FRP, SS,MSEP MSRL materials.
Activated Carbon Filters: Activated carbon filters effectively remove excess chlorine, odors, color, and colloidal impurities from water. APK supplied ACF in FRP, SS, MSEP, MSRL materials.
Micron Filters: Micron cartridge filters ensure the removal of particulate matter, from 100 micron to 0.2 micron sizes. This helps in reducing the TSS levels in water
Softeners: Softeners use cationic resin to exchange calcium and magnesium ions for sodium ions, preventing scale formation. Regeneration with common salt ensures continuous operation.
Ultrafiltration (UF): UF membranes effectively remove particulate debris and soluble chemicals, making them ideal for pretreatment in desalination, reverse osmosis
Chemical Dosing Systems: APK offer various dosing systems, including chlorine dosing for microbial control, SMBS dosing to neutralize chlorine, pH correction systems, and antiscalant dosing to prevent scale formation. Alum dosing for coagulation, polyelectrolyte dosing for flocculation etc
- Post Treatment
Electro Deionization (EDI): EDI units further polish purified water by removing ions using ion exchange resin and selective membranes, ensuring water meets USP standards.
Ultraviolet Sterilizers (UV): UV disinfection systems provide a chemical-free way to purify water by inactivating microbes, ensuring safe water consumption.
APK provides complete documentation and test certificates for all projects. For critical applications in the Pharmaceutical Industry additional documentation as follows is provided.
For System Manufacturing and Integration. URS/FRS/FATS, Process Safety Analysis [PSA], Process Safety Management [PMS] programs
For System Commissioning and Validation GMP Audit, SOP Development, O & M and PM Manuals and Training, DQ/IQ/OQ/PQ documentation
Water for injection (WFI) / multi column
A “Water For Injection (WFI) plant” is a system designed to produce ultra-pure, sterile water, known as WFI, for use in pharmaceutical manufacturing and medical applications, ensuring the water meets strict standards. Water for Injection is water of extra high quality without significant contamination. Water for Injection (WFI) is sterile water used for the manufacturing of pharmaceutical products which are administered parenterally, ophthalmically, or inhaled. WFI also is used for cell culture growth media, washing, and rinsing bioreactors in fast-growing biologic therapies.
Purified Water Generation System provides purified water as feed to wfi. In wfi column, it undergoes a distillation process. This is accomplished using either vapor compression or multiple effect distilling.
This procedure uses shell and tube heat exchangers (columns) to transfer heat via falling film evaporation. Each drop of water generated is heated to extremely high temperatures, ensuring the sterility requirements needed for WFI. The Pyrogenic load is separated using centrifugal forces created by the upward flow of the steam.
During the process, the feed and distilled water within the plant is constantly moving, so there is no stagnation. Impurities, together with the Pyrogenic load, are continually purged from the final column. The leftover collected water will be drained off during start-up during pre-heating and self-sanitization before WFI is created.
Systems producing WFI also need to undergo a validation process to ensure it is producing water that meets the required specifications in order to be used safely.
Pure steam generation
A Pure Steam Generator (PSG) is a system that produces high-purity steam, often used in critical processes like sterilization, sanitization, and humidification, especially in industries like pharmaceutical, biotechnology, and food processing. Pure steam is steam that has been treated especially to remove all impurities, making it suitable for applications require sterility and purity.
A vertical shell and tube evaporator connected to a feed water reservoir at the top and bottom is a feature of Pure Steam Generators’ design. With the inner surface of the tube in contact with feed water, utility steam is supplied to the evaporator tubes’ external surfaces. Boiling occurs when the feed water is heated, resulting in a vapor/liquid combination that fills the tube’s interior and forms a liquid layer at the tube’s surface. Steam occupies the tube’s interior. Because the liquid in the reservoir and the liquid in the tube have different densities, this causes a flow of feed water from the reservoir to the bottom of the evaporator, adding more feed water to the evaporator.
Sterilizing systems: Pharmaceutical companies that make pharmaceuticals utilize pure steam to sanitize difficult-to-reach equipment including tanks, pipelines, and filters before and after the creation of their products.
Pharmaceutical cleanrooms need to humidify the air to keep it sterile. Inadequate humidity management can halt production and result in contamination that cannot be repaired. Pure steam may be used to carefully manage how much moisture is added to the air, and it does so without significantly changing the air’s temperature.
Sterilizing the items employed in the sterilization process: Sterilizing pharmaceutical items inside the sterilization chamber minimizes cross-contamination during the manufacture of pharmaceuticals.
Purified water distribution system
Purified water distribution systems are utilized in many pharmaceutical units. They effectively distribute the purified and distilled water.
The water that has been purified from the upstream generating system. Water is subsequently sent from the storage tank to multiple user sites in the production area. The Storage tank & Circulation Pump is the main elements in water distribution system. Circulation pumps are responsible for ensuring turbulent flow in pipelines and maintain the required pressure in the system. The level transmitter utilized to manage the water level in the storage tank for purified water takes the required steps to keep the water level in the tank at a sufficient level. The distribution pump, online instruments for monitoring conductivity, temperature, pressure, and level, and a device for maintaining track of the level in the storage tank make up the distribution loop. Manual or Auto Diaphragm valves are used in every user point valve. The water is heated and cycled at high levels whenever the circulation loop has to be sterilized to prevent the formation of bio-films or to meet validation standards.
UV units for water disinfection devices are installed at the PW loop feed lines to minimize the risk of bacterial growth in the system. UV disinfection devices that are installed in water distribution systems for the pharmaceutical industry must be free from dead-legs and completely drainable. Instrument controllers and other ancillaries are provided in the control panel supplied with the purified water system. All automated valves and pumps are operated under the logic-based control of the control panel.
UV units for water disinfection devices are installed at the PW loop feed lines to minimize the risk of bacterial growth in the system. UV disinfection devices that are installed in water distribution systems for the pharmaceutical industry must be free from dead-legs and completely drainable.
Instrument controllers and other ancillaries are provided in the control panel supplied with the purified water system. All automated valves and pumps are operated under the logic-based control of the control panel.
