Water that is used in the medical device production process and pharmaceuticals needs to meet stringent standards. In pharmaceutical engineering, water is the most important solvent. Water can be used as an excipient or can be used for the reconstruction of products, during synthesis, as a cleaning agent, or during the production of the finished product. Depending upon the use, different grades of water quality are required. And, as manufacturers of pharma grade water filtration plants, we keep these requirements in mind. Moreover, Waterman Engineers Australia as an exporter offers comprehensive solutions for pharma-grade water plants, as per the client’s needs. In pharmaceutical production, there are four types of water:
- Potable water
- Purified water
- Highly purified
- Water For Injection (WFI)
Pharma Grade Water Purifying Technique:
Three types of water filtration systems are used in pharmaceutical industries.
Ion Exchange Water Filtration System:
In this system the undesirable water-soluble ions and exchanging with desirable ones. In this water treatment technology, the ionic composition is altered in a desirable direction.
Working of Ion Exchange System:
A microporous exchange resin is the main component for ion exchange systems. This resin is suspended in a loosely held solution. Sulfonated polystyrene beds supersaturated with sodium to cover the bed surface are used for water softening. When water is passed through the resin bed, the ions attach to the resin beads and release the loosely held solution in water.
The resin must be regenerated or exchanged when it becomes saturated. The exchange resin is flushed with brine to regenerate it. Sodium ions present in the salt brine solution are exchanged with the ions and flushed out with wastewater.
Ion Exchange Water Filtration System Advantages:
- Easy to operate.
- Minimal maintenance.
- Extremely effective for removing inorganic ions from water.
- The resin used can be regenerated
Reverse Osmosis Plant Process:
In this process, natural osmotic flow is disrupted by applying pressure to the concentration solution in an osmosis process. This results in the flow of water from a more concentrated to a less concentrated solution.
Working of Reverse Osmosis:
Reverse osmosis plants have multimedia prefilter, water softener or antiscalant dosing system, dichlorination dosing system, reverse osmosis unit with semi-permeable membranes, and ultraviolet sterilizers or post chlorination as a post-treatment.
The reverse osmosis technique is applied in RO plants in which particles larger than 10 microns are removed from feed water by passing it through a multimedia prefilter. Then an antiscalant chemical is injected to prevent hardness fouling that can damage the RO membrane. Hardness, chlorine, odors, color, ion, and sulfur are removed through these pretreatment options. The minerals, impurities, and salts that weren’t removed by the pre-filter are removed by passing water through a reverse osmosis unit in which a high-pressure pump applies extreme pressure to the highly concentrated solution and removes impurities. From the low-pressure end of the membrane, fresh, potable water comes out whereas, the salts, minerals, and impurities are discharged into a drain on the other end. Lastly, to kill bacteria and other microorganisms, water is passed through a UV sterilizer.
Advantages of RO Plant for Pharmaceuticals:
- Safe for the environment.
Pharmaceutical Water Distillation Unit:
In pharmaceutical practice, distillation is a widely used technique. As the feed water contains innumerable violent substances, the first ten to twenty percent of distillate should be discarded. Moreover, the last twenty percent should also be discarded to prevent excessive dryness which can result in the contamination of previous distillate by solid impurities. A liquid mixture containing volatile components is boiled by heat and condensation is used to recover the vapor. Additionally, as supplier we provide the best available solutions to reliably and affordably fulfil the performance requirements of these pharma grade water purifying systems.
Working of Pharma Water Distillation:
Distillation is a commonly utilised method in the profession of pharmacy. The first 10 to 20 percentage of the condensate should be removed since the supply water comprises a plethora of aggressive chemicals. Furthermore, the final 20% should be eliminated as well to avoid an inappropriate dryness that could cause solid contaminants to infiltrate the prior distillate. In order to reclaim the vapor, condensation is employed to boil an aqueous combination holding volatile components.
Pharma Distillation Plant Advantages:
- Effectively removes inorganic compounds.
- Microorganisms are also killed.
- Beneficial minerals are left behind while impurities are removed.
EDI Reverse Osmosis Plant – Electro deionization (EDI System):
A water treatment technology that is electrically driven and used, ion exchange membranes, electricity, and resins to purify water by removing ionized species.
Working of EDI Reverse Osmosis System:
EDI Reverse Osmosis Plant consists of chambers that contain ion exchange resins and are separated by ion-exchange membranes. When water enters the modules, an electrical field at right angles is applied to the flow that forces ions to move through resins and across membranes. The impurities are not bound to a media and are collected in a concentrated stream which is either directed to the drain r recycled.
EDI Reverse Osmosis Plant Advantages:
- Ion exchange beds are regenerated continuously.
- The impurities don’t build up and exhaust the resin.
- Can deliver more consistent purity.
Pharma Grade Water Plants Frequently Asked Questions:
1. What is pharma grade water?
In pharmaceutical production, the water used in processing, sanitizing and as a feedstock in medicines (IV FLUIDS) must meet the strict criteria on purity standards. That water typically known as pharma grade water, with around 0 to 1 ppm TDS. Different grades of water quality are used which depends upon the end use either water is used as a medium or can be used in the manufacturing process during synthesis, as a cleaning agent or during the production of finished product. As per client’s request, two types of water are used in pharmaceutical production:
- Highly Purified
- Water for Injection
2. Major techniques to produce pharma grade water
In pharmaceutical Industries, three types of techniques are used in the form of filtration systems to produce pharma grade water:
ION Exchange Water Filtration Systems: The deplorable water-soluble ions are exchanging with the desirable ones in this system and ionic composition of water is adjust in a desirable direction.
Reverse Osmosis Plant Process: In this technique, the natural osmotic flow of water is disturbed by applying pressure to the concentration solution in an osmosis process. This results in the flow of water from a more concentrated to a less concentrated solution.
Distillation Technique: This is the extensively used technique in pharmaceutical practice.
But the most used technique for bigger quantity is RO followed by EDI.
3. How pharma grade water was being produced through water distillation process?
In order to produce pharma grade water through distillation process, at first 10 to 20 percent of the condensate should be removed since the supply water comprises a large amount of harmful chemicals, later on, the final 20% should be eliminated as well to avoid extra amount of dryness which can result in the contamination of previous distillate by solid impurities. A liquid mixture containing volatile components is boiled by heat and then vapor is recovered with the help of condensation.
4. What is ELECTRODEIONIZATION, EDI?
It is a treatment technology that is driven by electricity and used ion exchange membranes, electricity, and resins to purify water by removing ionized species from water.
5. HOW ELECTRODEIONIZATION EDI IS useful to produce pharma grade water?
It is useful to produce pharma grade water because of the following advantages:
- In this technique, ion exchange beds are regenerated continuously.
- The impurities do not build up and deteriorate the resin.
- It delivers more consistent purity.
6. HOW ELECTRO DEIONISATION WORKS?
EDI plant consists of chambers that contain ion exchange resins and are separated by ion- exchange membranes. When water enters the modules, an electrical field at right angles is applied to the flow that forces ions to move through resins and across membranes. The impurities are not bound to a media and are collected in a concentrated stream which is either directed to the drain or recycled.
7. LATEST TREND to produce pharma grade water RO + EDI
Reverse Osmosis system, EDI is the latest trend to produce pharmaceutical grade water system. The purified water and water for injection can be used for Oral liquid, finished medicine, biological preparation, etc. The GMP, FDA required water systems have activated carbon pasteurization, CIP cleaning system, distribution system ozone sterilization, distribution system pasteurization as apart of system with the most important is the EDI as a polisher to achieve TDS less than 1 ppm approximately
8. What should be conductivity for pharma grade water?
Less than 4 μS/cm
9. What should be conductivity of injection grade water?
Less than 1 μS/cm