.bwtlogo0{fill-rule:evenodd;clip-rule:evenodd;} HOME WATER FOR INJEC­TION MEMBRANE PROCESS HOME PURI­FIED WATER MEMBRANE PROCESS DISTIL­LA­TION PROCESS PURE STEAM AQU@SERVICE SERVICES AQU@VIEW AUTOMA­TION QUALITY CORE TECH­NOLO­GIES 360° SOLU­TION PRODUCT OVERVIEW ABOUT BWT PHARMA & BIOTECH About BWT Careers Contact MEMBRANE-BASED WFI PRODUC­TION. THREE TIMES AS GOOD. The Euro­pean Phar­ma­copoeia and the United States Phar­ma­copoeia allow various processes. Primary cause: WFI produc­tion is safe. The OSMOTRON WFI handles this task in a reli­able, cost-effective, and envi­ron­men­tally friendly manner. Reasons for membrane-based WFI produc­tion To view this video please enable JavaScript, and consider upgrading to a web browser that supports HTML5 video REASONS FOR MEMBRANE-BASED WFI PRODUCTION A PERFECT DUO PRETREATMENT: SOFTENING OR ANTISCALANT SERVICE CONTACT THE ROAD TO MEMBRANE-BASED WFI MEMBRANE-BASED WFI For a long time, the only permitted method in Ph. Eur. for WFI gener­a­tion was distil­la­tion. Discus­sions and inves­ti­ga­tions on alter­na­tive processes that could also demon­strate the required levels of safety carried on for decades, notably in USP. The "interim quality" of highly Puri­fied Water was intro­duced until the change in the mono­graphs (0169) for producing WFI was published in April 2017, permit­ting alter­na­tive suit­able produc­tion methods. Bene­fits of WFI from the membrane process Previous Extra secure. The cost-effectively gener­ated WFI can be used for all purposes. This quality level ensures safety and saves time through addi­tional and earlier alarm and action limits. Envi­ron­men­tally friendly Removal of the distil­la­tion process and down­sizing the facil­i­ties results in huge energy savings. This is a good measure to combat global warming. Not using salt also helps our air and our water. Next Provi­sions In a risk-based approach, BWT engi­neers have taken all applic­able regu­la­tions into account when designing membrane-based WFI systems. In addi­tion to the Euro­pean Phar­ma­copoeia (Ph. Eur.), these include the United States Phar­ma­co­poeia (USP), the provi­sional Q&A docu­ment from the Euro­pean Medi­cines Agency (EMA), the latest draft of the revised Annex 1 as well as the ISPE manual "Herstel­lung von WFI ohne Destil­la­ti­ons­ver­fahren" (Gener­ating WFI without distil­la­tion) from the ISPE DACH Group "Pharma Wasser und Dampf" (Pharma water and steam). The result are two stan­dard­ized systems: OSMOTRON WFI and LOOPO WFI. When a tank and loops are added, they have every­thing needed for producing safe, cost-effective WFI between a potable water inlet and the point of use of systems tech­nology. Prod­ucts BWT OSMOTRON WFI The solu­tion for membrane-based WFI gener­a­tion. Featuring a triple membrane barrier for maximum safety. The dual-stage reverse osmosis func­tion is effec­tive while the exclu­sive, pharma-compliant SEPTRON WFI module for elec­trodeion­iza­tion and inte­grated final ultra­fil­tra­tion step ensure the... Find out more BWT LOOPO WFI The ulti­mate solu­tion for storage, distri­b­u­tion, and moni­toring of WFI at ambient temper­a­ture. Safety is ensured in the crit­ical WFI tank via contin­uous ozone sani­ti­za­tion and peri­odic LOOP sani­ti­za­tion with ozone or hot water > 75° Celsius. Find out more Good reasons for the membrane-based WFI gener­a­tion Previous Good for the envi­ron­ment No distil­la­tion means: Except for sani­ti­za­tion, no energy is used for heating and cooling. The membrane unit delivers a higher water yield instead of distil­la­tion and pretreat­ment. Not using salt is doubly good for the envi­ron­ment: simpli­fied handling reduces the CO2 foot­print consid­er­ably within trans­port logis­tics and, as no soft­ener regen­er­a­tion takes place, waste water containing chlo­ride is also a thing of the past. Avoiding consump­tion is intel­li­gent, sustain­able envi­ron­mental protec­tion. Next 1 2 3 Prod­ucts for membrane-based WFI produc­tion, ambient storage and distri­b­u­tion OSMOTRON WFI The shortest and most cost-effective way from potable water to WFI. LOOPO WFI Safely store and distribute WFI at ambient temper­a­ture 360° moni­toring and main­te­nance The right strategy to control risks. BWT places emphasis on moni­toring and main­te­nance for constantly safe system oper­a­tion and main­taining long-term value. The Euro­pean and the US Phar­ma­copoeia does - too. That's why we take a holistic, risk-based approach across the whole of the life cycle. That is Quality by Design. A matter of the right pretreat­ment Anti­s­calant or soft­ener - which pretreat­ment is best for membrane-based WFI produc­tion? The answer must be within the frame­work of an indi­vidual risk assess­ment. Previous The impor­tance of risk assess­ment when designing units for ultra-pure media has been given extra weight since the approval of membrane-based non-distillation processes for gener­ating WFI. Primary focus lies on pretreat­ment. Without proper pretreat­ment, the hard­eners dissolved in potable water quickly clog up the most impor­tant work stage, namely the reverse osmosis filtra­tion. Two processes offer the solu­tion: Soft­ening through ion exchange or a dose of anti­s­calant. Next 1 2 3 Down­load docu­ments WFI and Pure Steam in Best Quality PDF, 2 Mb Down­load Membrane-based WFI in Best Quality PDF, 1502 Kb Down­load AQU@ Service - Crit­ical Util­i­ties in the best hands PDF, 3 Mb Down­load Advice Belgium RESPONSIBLE BWT LOCATION BWT Belgium BV. Leuvensesteenweg 633 1930 Zaventem Belgium +32 2 758 03 10 bwt@bwt.be Contact us CONTACT PERSONS WFI systems are in the best hands during their entire life cycle with BWT AQU@Service. Discover what makes good service. Your system is in the best hands with BWT. Receive pure trust. Previous In the best hands. GMP main­te­nance by BWT The service engi­neer analyzes the process data at the begin­ning. He discusses results with the customer and carries out appro­priate measures if neces­sary. Find out more Next 1 2 3 4 5 back to top Follow us Face­book LinkedIn Solutions Puri­fied Water Water for Injec­tion Membrane process Distil­la­tion process Pure Steam Service Core Tech­nolo­gies About BWT Pharma About BWT Pharma & Biotech Careers Contact Miscellaneous Data Privacy Cookies Legal Notice © 2021 BWT Holding GmbH, A-5310 Mondsee EN