The pharma pure water guide contents introduction 2. Water for injection systems wfi pharmaceutical machinery. When quality, compliance, flexibility and efficiency are the essence of your existing or new purified or wfi water system, there is no better place to turn to than honeyman. Design concept for the validation of a water for injection system parenteral drug associations 2015 pda technical report no. Most of the known elements can be found dissolved in water, some in high concentrations and others only in trace amounts. Design of purified water and water for injection systems.
Water for injection wfi uspjp permits distillation or a purification process that is equivalent or superior to distillation in the. Water for injections wfi should be prepared from drinking potable water. Bhpw and wfi have identical microbiological requirements. Wfi generation systems utilising ro as the method of purification require careful consideration during validation, due to the potential risks. 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 use of clean steam in the biopharmaceutical industries is covered by good manufacturing practice gmp. In another system with endotoxin problems, it was noted that there was approximately 50 liters of wfi in the condenser at the startup. With over 50 years experience and with the industrial industryleading spectrum of technologies and products bwt is providing optimal solutions for all clean. Pharmaceutical equipment for water treatment, process and filling. Water for injection wfi preparation process and purified water preparation process.
Design of purified water and water for injection systems hugh hodkinson engineers ireland. Case study microbiological excursion during a phase i pq. The wfi system will store and circulate water at 80c from a 400 gallon ss316l storage tank and through ss316l piping to three distribution points. This classroom course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate usp and noncompendial waters. A full understanding of the drug production process is the key concept for correct design, born from almost 50 years of experience. Water for injection generation plant pharmaceutical wfi. Purified water, wfi and pure steam generation the honeyman group has builtup a longstanding reputation as the industrys leading expert in purified water, wfi and pure steam generation. Pure steam generators, multipleeffect water stills and application engineering assistance to make sterile water for injection in pharmaceutical manufacturing. Pharmaceutical waters guide for regulatory compliance, analysis. Tecninox has a great experience in design, supply, installation and validation of pu rified water, wfi distribution system. It must meet the same chemical specification as pw, but a. Pharmaceutical water systems training course classroom. Depending on the water purification process online ph measurements may be found in the generation system.
Bramcor engineering team focuses mostly on fluid drugs sterile production processes. In the upper right corner of the page, click on water facilities inventory report wfi. Pure steam generators wfi stills steris life sciences. Qualification of purified water and water for injection. Validation of water for injections wfi for biopharmaceutical. Pdf on jan 1, 2009, t h meltzer and others published reverse osmosis as a means of water for injection production. In addition to the normal parameters, special attention is on the parameters that influence the microbiological quality. Furthermore, a system concept will be presented for a membranebased wfi generation. Generation storage and distribution system for purified.
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. The correct selection of the process and system dimensions are key to the proper functioning of a membranebased wfi generation system, and the process combination depends on the quality of the feed water. There are basically two types of water preparation in pharmaceuticals. Since this water could lie in the condenser for up to. Purified water pw generation system each plant for the production of purified water is custom made, whether its capacity is 100 lh or over 25 m3 h. More substances dissolve in water than any other solvent. Experts in high purity water for pharmaceutical use. Generation system infeed generation system outfeed as close as possible to each user point. Water for injection generation plant download brochure product enquiry over the last 30 years, pharmalab has been the leading supplier of plants producing water for injection, which meets international standards, including usp, ip, bp and jp. Clean and pure steam systems biopharmaceutical industry. Pw must meet a chemical specification for conductivity and total organic carbon toc, and a microbial specification. Pdf reverse osmosis as a means of water for injection. Main target is avoiding of potential of microbial growth.
Water for injection system qualification process solutions. Enter your 5digit water system number in the water system id, click search. The system can therefore provide a simultaneous production of pure steam and water for injection. Pw and wfi storage and distribution systems design. As such the qualities at the point of use are regulated in the different international pharmacopeia. The storage and distribution system has the role to provide a buffer by holding the required quantity of water, based on the daily water usage and the water generation capacity, and supply it to the users at the points of use pou, while maintaining the chemical and microbial quality of water. Parenteral drug associations 1983 pda technical report no. Of the four systems considered, the ufvc system represents the secondmostexpensive capital expenditure behind the rome system but offers significant operating advantages relative to the membranebased system and the me system.
In the vc process, the vapor produced by evaporating the water is compressed to increase the saturation pressure and temperature. Pw and wfi storage and distribution systems design and. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water. In addition to noncompendial systems, pharmaceutical facilities typically include systems for delivering pharmacopoeial purified. Pharmaceutical water is, perhaps, the most important of all pharmaceutical utilities. Performance qualification protocol for water for injection. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In europe, wfi can only be produced by distillation. Pdf design, qualification, and validation of water systems. You may purchase usp24 by calling customer service at 800 8776733. Contact us to discuss your water system related challenges. Wfi distribution loop system has the following special features. There is also equivalent european pharmacopia ep and japanese pharmacopia jp, the limitations of which are very similar.
Many years of experience and continuous development has led to all our plants being very user friendly and robust. If available space is tight, we can efficiently integrate generation, storage and distribution into a single packaged assembly. Preparation process for water for injection wfi in. Usp allows for wfi production by ro or by distillation. Usp24 contains complete versions of all pharmaceutical water monographs p. Every plant is designed with the customer and all the design parameters in minute details and with the same passion and dedication towards building an effective, safe and reliable system. Vapor compression distillation pharma vapor compressions. March 12, 2017 pw and wfi design and operation 7 us food and drug administration fda 21 cfr part 210 21 cfr part 211 21 cfr part 11 pharmacopeias of us, europe, japan usp, ep, jp various gmps from european countries eudralex volume 4, gmp guidelines part 1, basic requirements for medicinal products annex 1 manufacture of sterile products. A response to the position of the european medicines agency find, read and. General principles for pharmaceutical water systems. Ozone is commonly used for sanitization of cold storage and distribution system and to prevent microbiological growth, however this is not a requirement of the usp. The following topics to be covered during training. Free water and wfi to international pharmaceutical standards is widely recognised as a critical process.
Principle and operating of water for injection system. Wfi pure steam generation bwt best water technology. The objective of this protocol is to qualify and certify the performance of the water for injection generation, storage and distribution system. This training is related to the water for injection generation, storage and distribution system and being imparted to the people involved in the wfi water system validation. The ufvcbased wfi generation system has the following energy and water recovery profile. Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a. Our first step in any successful project is being able to clearly define outcomes and goals. The system for the cold generation of wfi bwt best water. Ipec offers generation and distribution systems to provide a complete water solution for your next project. To establish the methodology for the performance qualification of wfi generation, storage and distribution system id.
569 135 243 328 487 1257 573 1363 801 844 973 1557 1608 181 588 673 1102 851 950 939 1082 1485 872 224 507 279 287 2 1180 692 769 659 1392 1350