Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person s.
Purified Water Distribution System
This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. It also includes a review of the design of the various types of systems and some of the problems that have been associated with these systems.
As with other guides, it is not all-inclusive, but provides background and guidance for the review and evaluation of high purity water systems. One of the basic considerations in the design of a system is the type of product that is to be manufactured. For parenteral products where there is a concern for pyrogens, it is expected that Water for Injection will be used.
This applies to the formulation of products, as well as to the final washing of components and equipment used in their manufacture. However, in the bulk Pharmaceutical and Biotechnology industries and some foreign companies, Ultra Filtration UF is employed to minimize endotoxins in those drug substances that are administered parenterally. For some ophthalmic products, such as the ophthalmic irrigating solution, and some inhalation products, such as Sterile Water for Inhalation, where there are pyrogen specifications, it is expected that Water for Injection be used in their formulation.
However, for most inhalation and ophthalmic products, purified water is used in their formulation. This also applies to topicals, cosmetics and oral products. Another design consideration is the temperature of the system. It is recognized that hot 65 - 80oC systems are self sanitizing.
While the cost of other systems may be less expensive for a company, the cost of maintenance, testing and potential problems may be greater than the cost of energy saved. Whether a system is circulating or one-way is also an important design consideration. Obviously, water in constant motion is less liable to have high levels of contaminant. A one-way water system is basically a "dead-leg". Finally, and possibly the most important consideration, is the risk assessment or level of quality that is desired.
It should be recognized that different products require different quality waters. Parenterals require very pure water with no endotoxins. Topical and oral products require less pure water and do not have a requirement for endotoxins. Even with topical and oral products there are factors that dictate different qualities for water. For example, preservatives in antacids are marginally effective, so more stringent microbial limits have to be set. The quality control department should assess each product manufactured with the water from their system and determine the microbial action limits based on the most microbial sensitive product.
In lieu of stringent water action limits in the system the manufacturer can add a microbial reduction step in the manufacturing process for the sensitive drug product s. A basic reference used for the validation of high purity water systems is the Parenteral Drug Association Technical Report No. The introduction provides guidance and states that, "Validation often involves the use of an appropriate challenge.
In this situation, it would be undesirable to introduce microorganisms into an on-line system; therefore, reliance is placed on periodic testing for microbiological quality and on the installation of monitoring equipment at specific checkpoints to ensure that the total system is operating properly and continuously fulfilling its intended function.Water for injection WFI is used in the pharmaceutical industry to formulate parenteral drugs and for cleaning and other manufacturing operations.
Reverse osmosis followed by a polishing step can be a more efficient and cost-effective solution for WFI production. Because WFI can be incorporated into final drug formulations, the quality requirements are extremely high. Traditionally, WFI has been produced via distillation, but in the United States and Japan, pharmacopeia monographs have allowed other methods, as long as the same quality can be achieved. Following the publication of its new monograph on WFI in Aprilthe European Pharmacopoeia was brought in alignment.
The conductivity of WFI must be less than 1. Total organic carbon TOC must be less than 0. WFI in pharmaceutical manufacturing facilities has traditionally been produced via multiple-effect distillation MED and vapor compression distillation VC in large stainless-steel equipment. This method basically involves boiling water and allowing the steam to travel through a large column or evaporator.
In the case of MED, this process is repeated multiple times to increase equipment efficacy and capacity. Because distillation involves boiling the water, it is an effective method for removing bacteria and endotoxins. In addition, the WFI produced using this method is hot, and distribution of water at a high temperature minimizes the risk of microbial contamination after the purification process is complete. However, due to the high temperature of the process, the water must be pretreated to remove chlorine and other contaminants that can damage the stainless-steel used to construct MED and VC distillation equipment.
Generally speaking, the minimum acceptable feed water for a multiple effect distiller closely approximates compendial Purified Water and WFI by corollarymeaning a significant reduction in scale, chlorine and ion removal is necessary before distillation.
In practice, many systems used for pre-treatment of MED feedwater often produce water quality that meets WFI specifications, which makes membrane production of WFI an attractive alternative.
Reverse osmosis RO technology has been around for over years. Its use for WFI production, however, has only been allowed in the United States for a little over 30 years. Highly purified water was introduced to the European monograph inwhich meets the same quality specification as WFI with respect to conductivity, TOC, bioburden and endotoxin but can be produced using membrane filtration technology that is equivalent to distillation. WFI, however, could only be produced via distillation until The generation of more than a decade of data on the safety and quality of RO-produced water likely led to the acceptance of this method for WFI production.
In the next version of the EU Pharmacopoeia Ph. Like MED and other distillation technologies, pretreatment of the water must be performed before purification via RO, owing to the sensitivity of the polyamide thin-film membrane to damage by chlorine and ammonia.
The pretreated water is passed tangentially across the membrane, producing transmembrane pressure that effectively rejects a water stream containing heavier ions and allows water containing fewer ions to pass through. RO systems are often designed such that approximately 8 of every 10 gallons passed across the RO is recovered; however, systems can be designed with greater efficacy depending on project requirements and budget.
Most systems include two passes. A polishing step, typically electrodeionization EDI followed by ultrafiltration UF is then performed. This step is necessary because, while RO is very good at removing endotoxin, there is some risk that bacteria can grow on the backside of the membrane, generating more endotoxin that could potentially pass downstream. UF ensures that effective endotoxin reduction is achieved through the use of a molecular weight cut-off UF.
RO is performed at ambient conditions, which creates an ideal environment for microbial growth. Heat-sanitizable membrane systems, in particular, allow for control of the formation of biofilms.
Like all other pharmaceutical manufacturing equipment and processes, they must also be qualified and validated.
Systems are typically run for an extended period of time — often a minimum of 30 days — with regular monitoring to characterize their performance with respect to water purity and to demonstrate a controlled and consistent process. The decision to select RO or distillation for WFI production requires consideration of several factors. The first is capital cost. A typical traditional MED system takes up a large amount of plant floor space and consumes a significant quantity of energy for steam generation and cooling, contributing to high operating costs.
Vapor compression distillers can require significantly less pre-treatment and can be competitive in larger scale WFI production; however, cost and space constraints can be a challenge. In contrast, membrane systems generally do not require steam or cooling.
Sanitization of the RO membranes and piping can be accomplished using an electric heater, but steam can be used if available. Since the membrane WFI generation system is the terminal process the space requirements for the MED can be eliminated.
There is also potentially less welding required and less stainless steel used in their production, allowing for faster delivery.Home Sterile Water.
Preparation Process for Water for Injection WFI in Pharmaceuticals Water for injection is used in sterile manufacturing and its preparation and storage is a critical process. Ankur Choudhary Print Question Forum 3 comments.
Water for Injection WFI preparation process and purified water preparation process. The analytical standards for the two water are almost very similar, the only difference is that Water for Injection WFI system in pharmaceuticals has stricter bacterial control standards than USP standards for purified water process and has to pass the bacterial endotoxin test. Preparation methods are very similar to a particular point, however, Water for Injection WFI preparation process in pharmaceuticals must include distillation or double pass reverse osmosis techniques.
Dechlorination: This refers to the removal of chlorine from the water. There are several ways of dechlorination. This include injection of a reducing agent like sodium metabisulfite and exposure to a high dosage of UV rays can dechlorinate. However, the most common one is filtration through activated carbon media.
Water for Injection WFI preparation process in pharmaceuticals is dechlorinated by carbon. Carbon dechlorinates by chemically reacting with the free chlorine in water to form hydrochloric acid and carbon monoxide or dioxide. High doses of UV light rays are widely used in water purification systems for both disinfection and TOC reduction. Another use of UV is dechlorination though it is a relatively new process. Ion removal: There are basically three types of ion reduction processes these include membrane processes, ion exchange processes, and distillation processes.
Membranes are used in water purification systems to remove ions, remove particulate, remove organic compounds, and remove living organisms. Membranes are different from one another in terms of pore size, molecular weight, and even on ion rejection.
Ion removal membranes include membranes such as reverse osmosis membranes and nanofiltration membranes. These are used in ion reduction processes. The ion exchange systems provide additional ion reduction process, making the water much lower in conductivity than required and it also provides a back up for membrane process. Distillation can also be used to remove ion, however, it is very expensive.
Bacterial control: In bacteria control, one has to be careful to ensure that bacteria does not pass to pharmaceutical water for injection. Bacteria control includes both procedures and equipment.The Multiple effect stills consist of a series of pressure vessels in the form of columns, called distillation columns or effects, that are interconnected, communicating vessels.
Each column is divided into two parts:. Pharmaceutical water, defined in the European Ph and the USP, is used for preparing parenterally administered medicines, when the water is used as a vehicle bulk water for injection and to dissolve or dilute substances or preparations for parenteral administration before use sterilized water for injection.
According to the Ph Eur 4, water for injection can only be produced by distillation, using drinking or purified water as a source. Plant steam is applied only to the first column evaporator effect with the subsequent columns using the steam produced in the previous column as the source of energy. Similarly, cooling water is applied only at the condenser to condense pure steam into water for injection. The columns subsequent to the first column use feed water as the cooling source, which is evaporated, as the pure steam from the preceding column is condensed producing water for injection.
Easy to Maintain — Latest PLC controls and commercially available components enable lower maintenance costs. Highest WFI Quality — Patented three stage pyrogen separation and continuous blowdown removal from each distillation column.
Water For Injection Generation Plant
Easy to Validate — Units are fully tested and pre-validated to customer specifications during factory qualification.
Toggle navigation Menu. WFI Generation. Home WFI Generation. Each column is divided into two parts: A double tube sheet DTS heat exchanger that acts as an evaporator, And an upper chamber used to separate pyrogens preventing the drops carrying impurities from reaching the end of the column. The group is supplied as a compact unit on a skid with all components readily accessible. Cost Savings — Patented column design helps lower energy consumption.Available in capacities ranging from 80 - LPH, the Multicolumn Distilled plant is used for its economy, low maintenance and low operation costs.
If WFI is to be stored overnight or for a longer period of time, then it is essential to keep it in hot condition, at around 80 C.
Distilled Water Storage Tank with jacketed design, where heating medium is either boiler steam or electrical heaters in the jacket, provides you with an ideal solution. WFI Storage tank will have the following special features. Pure Steam Generator for the Pharmaceutical and Biotech Industries is the most reliable technology for producing pure, Pyrogen free sterile Steam.
The use of Pure Steam Generator will have the following advantages:. Pharmaceutical Machinery. Call Now! Compact in design. Electro polished creviceless inner contact surfaces. PLC based system for automated operation. Sanitary triclover fittings for quick and easy preventive maintenance. Double tube Sheet construction for the first column, where boiler steam is present.
Synoptic panel board with facility for logging the data can also be given. WFI Storage tank will have the following special features The tank is designed to withstand pressure as well as vacuum.
Therefore it can be steam sterilized. No stagnant points which will promote bacterial growth. All surfaces are creviceless and having high degree of finish. Insulation with SS welded sheeting and jacket provided on the tank will minimize heat loss. Electropolished interiors are provided as optional. Temperature Indicator cum Control Arrangement. Level Indicator cum Controller.
Pressure Gauge and Safety Valve. Diaphragm Valve. SS panel. Externals Mechanically polished to grit finish. Welding technique - Automatic Orbital Welding. All interconnections through triclovers.Purified water plant complete detail in Hindi
All valves are of self draining type. All gaskets are of Teflon. Entire installation will be completely drainable. Slope of the low point must be 1: minimum. Following accessories are supplied as a part of the loop system WFI circulation pump.Post a Comment. Home Protocol Validation. Performance Qualification Protocol for Water for Injection WFI System Learn the validation procedure and how to write the validation protocol for water for injection system in pharmaceuticals.
The objective of this protocol is to qualify and certify the performance of the Water for Injection generation, storage and distribution system. This protocol is applicable to water for injection generation, storage and distribution system. C, and Engineering department. C and Production department. It removes the impurities at sterile temperature without using any filtration medium. Number of effects is connected in series. Source of energy for the first effect is Boiler Steam and the remaining effects use the intrinsic heat to supplement consumption needs of heating energy.
The falling film is heated with plant steam and causing it to a instant flash evaporation. This flash evaporation helps the steam to leave behind the heavier particles or droplets First stage of Separation. This transformation from water to steam significantly increases the velocity as it approaches the bottom of the column with high pressure.
This directional change induces the separation of large water droplets Secondary Separationwhich falls into the bottom of the column, where they are collected with excess feed water that has not evaporated. The resulting centrifugal action forces the remaining microscopic droplets and impurities including the Endotoxins to the outer surface, which then gets blow down through the windows provided on the separator Third stage Separation.
The resulting steam is pure pyrogen free sterile steam. Normal minimum velocity of WFI in loop is 2. The water quality parameters such as Total Organic Carbon, Conductivity and temperature are monitored online. The duration of this phase will be 21 days.
During reduced sampling frequency, all sampling points of WFI shall be covered within a week time in rotation.The designing of the Purified Water Distribution System requires detailed engineering towards achieving a sterile environment. Features Hassle-free operation Occupy less space Optimum performance. Thank you Your Enquiry has been sent successfully. Thank you! Your enquiry has been sent successfully. Your requirement has been sent successfully. Our Products.
Purified Water Distribution System We are a leading Manufacturer of purified water distribution system, purified water generation system, edi system, wfi distribution loop system, purified water storage tank and pharmaceuticals water generation system from Ahmedabad, India.
Purified Water Distribution System. Get Best Quote. Request Callback. I am interested. Purified Water Generation System. EDI System. Purified Water Storage Tank. Pharmaceuticals Water Generation System. Ask For Price. Product Price : Get Latest Price. Purified Water Distribution Systems. Water Distribution Systems.
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