Pharmaceutical water system design operation and validation pdf. Assessment of purified water quality in pharmaceutical. Approaches to commissioning and qualification of pharmaceutical water and steam systems, discusses practices and activities associated with the commissioning and qualification verification of pharmaceutical water and steam systems. Pharmaceutical water systems training course classroom.
Water, highly purified water, pyrogen free water and wfi to international pharmaceutical standards is widely recognised as a critical process. Terms such as pure steam, pyrogen free steam and low endotoxin steam are encountered in the pharmaceutical industry, and may have specifications that are the same or different to those of clean steam used on other sites. Reverse osmosis system contains a semipermeable membrane that allows passing the water and rejects the contaminants. Pharmaceutical water production, storage and distribution systems. To better control this critical media, the pharmaceutical industry has defined two. System design, operation, and validation, second edition crc press book a major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industriesused as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. Waste water treatment in the pharmaceutical industry. This article is intended to discuss the effectiveness, consistency and reproducibility of a water treatment system along with its validation aspects. The best and easiest to read technical books on water systemsbar none. Venkateswara reddy and others published water treatment process in pharma. Reverse osmosis system basics for water purification. General principlesrequirements for pharmaceutical water systems. Material and methods the investigated system the system for water purification is intended to remove.
With thousands of water purification machines successfully installed around the world, meco serves leading pharmaceutical and biotech companies with over 25 million gallons of product water each day. Water is the most common used liquid in the pharmaceutical industry, not only as an ingredient in many. Insulating materials exposed to stainless steel surfaces should be free of chlorides to avoid the phenomenon of stress corrosion cracking that can lead to system contamination and the destruction of tanks and critical system components. For nonparenteral products it may be used in product formulation and final washing of process equipment and containers. Oct 20, 2017 when choosing a purified water system for the pharmaceutical industry, there are a variety of different approaches to be considered. Pharmaceutical utilities, current regulation, qualification. In order to assess the quality of different water treatment steps, water samples were taken from each processing stage in the water station and analyzed microbiologically using standard procedure. Purified water is used as an excipient in the production of nonparenteral preparations and in other pharmaceutical applications, such as cleaning of certain equipment and nonparenteral productcontact components. Sampling a pou must include any pathway that the water travels to reach the process. Services used by a factory include compressed gases, water, vacuum, electricity and room air conditioning. Water for pharmaceutical use international journal of. Water is one of the major commodities used by the pharmaceutical industry. Water solutions for the pharmaceutical industry water is the most common used liquid in the pharmaceutical industry, not only as an ingredient in many formulations, but also as a cleaning agent.
Pharmaceutical water production, storage and distribution. Water is a chemical substance with the chemical formula h 2 o. This process is used to remove the particles including ions from the water. The production of purified water, highly purified water and water for injection to international pharmaceutical standards is widely recognised as a. Journal of chemical and pharmaceutical research, 2015, 74. On water systems the details are what makes the difference between a system that works well and is easy to maintain. It is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients apis and intermediates, and analytical reagents. Defined as the location where water, from the distribution system, is used. Because of the multiplicity of endotoxin sources in a water system, endotoxin quantitation in a water system is not a good indicator of the level of biofilm abundance within a. Direct connections to processes or auxiliary equipment should be designed to prevent reverse flow into the controlled water system. Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a major concern. The discussions focused on three aspects of rouge, including. Sample as close as possible to the process equipment.
Choice of materials, quality control engineering, system design. How to get the ideal purified water system for the. The guide focuses on items which directly affect quality. We deliver complete water treatment solutions that meet and exceed these standards through. Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Oct 18, 2017 the pharma industry needs to think about how to use water more efficiently, because the cost is going up, says krpan. Drinking water, water for injection, distribution system of water, different grades of water quality. May 03, 2016 purified water system in pharmaceuticals 1. Unless otherwise specified, purified wateris also to be used for all tests and assays for which water is indicated. Purified water systems for pharmaceutical manufacturing.
Pharmaceutical utilities, current regulation, qualification and validation. Water for pharmaceutical use global research online. Hence, this article in detail discuss the effectiveness, reproducibility and consistency of a water treatment system along with its validation aspects. The meco global portfolio includes the broadest range of engineered products for pure steam, purified water pw, highly purified water hpw and. Water solutions for the pharmaceutical industry veolia water. General principles for pharmaceutical water systems.
Purified water system in pharmaceuticals slideshare. Water treatment describes those industrialscale processes used to make water more acceptable for a desired enduse. Technical parameters such as cross flow rates and membrane flux are among the most conservative in the industry. Zero liquid discharge, a concept that is new to the pharma industry, is a potential solution to the watershortage problem that involves recycling or reusing process water. This second edition of the ispe good practice guide. Water is extensively used as a raw material, ingredient, and solvent in the processing, formulation. The distribution design should include the placement of sampling valves in the storage tank and at other locations, such as in the return line of the recirculating water system. Highgrade stainless steel with specified sulphur and low delta ferrite content is our standard. Strategic of applying free chemical usage in purified water system. Key wordspurified water system, pharmaceutical industry, free chemical. Nov 03, 2017 pharmaceutical water system ppt what is pharmaceutical water principles pdf.
Within the pharmaceutical industry, water is most commonly used in liquid form, not only as an ingredient in many formulations but also as a cleaning agent. A system consisting of one or more components to form a structure designed to 217 collectively operate, function or perform and provide a service such as electricity, water, 218 ventilation or other. The goal of water treatment process is to remove existing contaminants in the water. The ideal approach combines validation requirements, cost efficiencies, and service requirements for the pharmaceutical industry. For quick and easy installation, the pharma x is supplied as a complete insulated module with a pitot tube arrangement and either manual or automatic valves. With a proven track record of more than 90 years as a supplier to the pharmaceutical industry, we guarantee safe, easy and problemfree installation. Pou sampling for qc, should mimic the way the water is used for manufacturing. Pdf various grades of water are essentially used in most of the pharmaceutical preparations and related industrial processes.
Pharmaceutical water system ppt what is pharmaceutical. Water quality play important role in pharmaceutical industry, water quality should be measure by various parameter of water and also various. The production of purified water, highly purified water and. But the reality shows that the potable water could be from public water supply system or natural sources, natural sources could include springs, wells, rivers and lakes although reasonably pure, it is always variable due to seasonal variations, regional variation in water quality is influenced by, e. Guideline on water for pharmaceutical use european medicines. Reverse osmosis is the bestknown filtration method and it is widely used in pharmaceutical water systems. This classroom course on pharmaceutical water systems has been substantially updated to feature the guiding principles of the ispe baseline guide with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. Pharmaceutical water system ppt what is pharmaceutical water principles pdf. Pdf design, qualification, and validation of water systems. The format is greatgive you the scientific theory and also combines practical application details. The free form of endotoxins may be released from cell surfaces of the bacteria that colonize the water system, or from the feed water that may enter the water system. Meco reverse osmosis ro units incorporate all of the components and instrumentation required for operation, as well as the versatility to adapt to specific customer requirements.
Production of purified water, highly purified water, pyrogen free water and wfi to international pharmaceutical standards is widely recognised as a critical process. By this they mean access to the system for sanitization or. These can be use for drinking water, industry, medical and many other uses. Cop held a series of workshops on pharmaceutical water and steam. The wastewater is highly variable with high solvent concentrations. Water system in pharmaceutical industry pharmastate blog. Water systems for pharmaceutical facilities index of. Type of water purified water water for injection product to be manufactured temperature of system 3.
Introduction ater is a key ingredient used in many pharmaceutical and life sciences operations. Installed in a water system, the pharma x module can be regarded as a subloop of the main loop. Purified water systems may be used for a variety of purposes in pharmaceutical manufacturing. Pharmaceutical water purification solutions biotech meco. All product wetted parts in the pharma x are electropolished and the tubes as seamless. Water is a liquid at standard condition for temperature and pressure, but it often coexists on earth with its solid state and. There is a wide range of waste water streams produced as byproducts of chemical synthesis, fermentation, and formulation operations in the pharmaceutical and. Water is a component of every pharmaceutical product, so water system must be validated to ensure the consistent production of high. The production of potable water purified water used in pharma processes is usually produced insitu from local potable water which has been produced by the treatment of natural water sources. Water for pharmaceutical industry purposes 2 water is one of the most commonly used substances, vehicle, raw materials, or an ingredient in the production.