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Puri­fied Water in line with Ph. Eur. and USP

Top-​quality Puri­fied Water. Every­where and any time.

BWT systems make life simple, better and safe. Discover homog­e­nized systems and compre­hen­sive services for the gener­a­tion, storage, and distri­b­u­tion of Puri­fied Water.
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    • PW quality in accordance with pharmacopoeias
    • BWT systems
    • Technologies
    • Service
    • FAQ
    • Contact

    Puri­fied water require­ments

    Ph. Eur. & USP

    Phar­ma­copoeias clearly set out quality require­ments for puri­fied water

    Puri­fied Water, also known as Aqua Purifi­cata, is an essen­tial raw mate­rial. Large quan­ti­ties are frequently required. It is produced on-​site, directly from the potable water that is avail­able. The Euro­pean Phar­ma­copoeia (Ph. Eur.), as well as the United States Phar­ma­copoeia (USP) and the Chinese Phar­ma­copoeia (ChP), set out clear thresh­olds for puri­fied water quality at the point of use. They clearly state maximum values for the micro­bi­o­log­ical load in the form of colony-​forming units, the conduc­tivity of the Puri­fied Water, and quan­tity of organic carbon.

    Forward-​looking customers set out even more strin­gent require­ments in their ultra-​pure systems for gener­a­tors to ensure produc­tion is far beyond threshold values. This ensures there is enough margin between the ultra-​pure media system and the point of use for alarm and action limits—without the poten­tial risk of an "out of spec­i­fi­ca­tion" inci­dent. Since conduc­tivity is changed by adding CO2, it is also worth using measures such as CO2 traps for tank venti­la­tion in the storage and distri­b­u­tion system, for example.

    USP Ph. Eur. ChP
    TOC ppm C ≤ 0.50 ≤ 0.50 Same as Ph. Eur.
    Conduc­tivity µS/cm ≤ 1.3 (25°C) ≤ 4.3 (20°C) Same as Ph. Eur.
    Nitrate (NO3) - ≤ 0.2 ppm ≤ 0.000006%
    Heavy metals
    		- ≤ 0.1 ppm Pb ≤ 0.00001%
    Aerobic bacteria CFU/ml ≤ 100 ≤ 100 Same as Ph. Eur.

    BWT OSMOTRON Pro

    It is widely believed to be the undis­puted bench­mark in producing Puri­fied Water. Every­thing is installed on a compact frame: Prefilter, soft­ening, reverse osmosis, and SEPTRON elec­trodeion­iza­tion. And addi­tional the inte­grated AQU@View Automa­tion gives oper­a­tors full control of the process at all times.

    • Stan­dard­ized, ready for connec­tion, and prequal­i­fied
    • Readily acces­sible for sampling and main­te­nance
    • Ready for the future: Modular expan­sion
    • Up to 12 m³/h PW on one frame, up to 30 m³/h as multi-​skid
    • Our top seller: World­wide > 1,000 systems in oper­a­tion
    Osmotron Osmotron

    BWT LOOPO

    Great things in small pack­ages. In our opinion, there is only one correct answer for the safe storage and distri­b­u­tion of PW to the point of use: The LOOPO. Thanks to the ozone elec­trolytic gener­ated directly from Puri­fied Water by STER­ITRON, the micro­bi­o­log­i­cally crit­ical tank is safe. Water is free of ozone in the loop since BEWADES UV removes it until it is below a detectable level - unless it is required to auto­mat­i­cally ozonate the distri­b­u­tion loop peri­od­i­cally.

    The LOOPO is avail­able in stan­dard­ized models for flow rate and sani­ti­za­tion config­u­ra­tions.

    Loopo Loopo

    Prod­ucts for PW gener­a­tion, ambient storage and distri­b­u­tion

    Compact, stan­dard­ized systems combine all neces­sary process steps and tech­nolo­gies to reli­ably ensure the highest levels of safety within the process. Every unit is fully tested and qual­i­fied in the factory before delivery (FAT). It is then preval­i­dated and deliv­ered with full docu­men­ta­tion.

    Septronline
     
    SEPTRON­Line Puri­fied Water The compact and econom­ical solu­tion.
    Osmoline
     
    OSMO­Line Puri­fied Water The open stan­dard compact unit with excel­lent automa­tion.
    Osmotron
     
    OSMOTRON Pro Puri­fied Water The measure. The refer­ence. Synony­mous with PW gener­a­tion. Excep­tional.
     
    LOOPO­Line Puri­fied Water Gener­a­tion, storage, distri­b­u­tion, and moni­toring in an extremely small foot­print.
    Loopo WFI
     
    LOOPO C Puri­fied Water The solu­tion for safe PW storage, distri­b­u­tion, and moni­toring.
    Biostil
     
    ULTRA­STIL Puri­fied Water Robust and reli­able pretreat­ment with more demanding feed water.

    Outstanding Puri­fied Water tech­nolo­gies

    Exclu­sive BWT solu­tions for the pharma and biotech sectors

    Our objec­tive: Deliv­ering the best solu­tions to our customers. That's why we work constantly to improve processes and tech­nolo­gies. Our primary focus is on quality, safety, envi­ron­mental protec­tion, and cost-​effectiveness.

    SEPTRON Elec­trodeion­iza­tion

    The module, which was specially devel­oped for the phar­ma­ceu­tical industry, deion­izes RO permeate. The func­tion is a combi­na­tion prin­ciple of ion exchange and elec­tro­dial­ysis.

    • 316 L housing
    • Seal-​free spiral-​wound tech­nology
    • Through­flow with little dead space
    • 100% factory tested & certi­fied
    Find out more
    Septron

    Advice

    United States

    Responsible BWT Location

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    AQU@Service for PW systems

    Maximum safety, reli­a­bility, and value reten­tion in crit­ical produc­tion appli­ca­tions are achieved via quality systems, preven­ta­tive service, and intel­li­gent spare parts manage­ment.

    The planned AQU@Service with replace­ment of all wear parts, docu­mented cali­bra­tion of sensors, and replace­ment of all seals and membranes means you're on the safe side with BWT when audits and inspec­tions occur.

    FAQ

    Is the Biocidal Prod­ucts Regu­la­tion a problem?

    No. BWT is active in EurO3zon in close coop­er­a­tion with market players.

    How much does a PW system from BWT cost?

    Expe­ri­ences gleaned from hundreds of projects and thou­sands of completed systems mean that BWT has a wide range of stan­dard­ized units for producing PW and WFI. They are impres­sively reli­able and the compo­nents are intel­li­gently config­ured.

    The unit is designed based on water analysis. Major cost drivers include indi­vidual customer require­ments and wide-​ranging URSs that go far beyond what is tech­ni­cally expe­dient. BWT Pharma & Biotech also provides advice to its customers in this sector in order to provide the best solu­tion for ultra-​pure media require­ments.

    Is it true that the output of units can be easily expanded?

    It is defi­nitely the case in certain areas. As an example, an OSMOTRON Pro, with a capacity of 3 m³/h PW can be upgraded during sched­uled main­te­nance to produce up to 6 m³/h PW in the stan­dard ranges. However, physics is a barrier for the loops—only a maximum quan­tity of water can flow through a specific diam­eter in a specific period of time. Together with BWT, plan­ners and project managers can find the ideal solu­tion for any neces­sary modi­fi­ca­tions along with all neces­sary loops.

    Is ozone really safe for storing puri­fied water?

    Certainly—thou­sands of instal­la­tions for hundreds of customers demon­strate this. If we didn't think so, we simply wouldn't use it. It has been used in water treat­ment for decades. A constant ozone concen­tra­tion of 20—30 ppb effi­ciently and contin­u­ously prevents any germ growth, partic­u­larly in the PW tanks which are micro­bi­o­log­i­cally crit­ical without ozone. The ozone is reli­ably removed by UV until it is below detectable levels before the water reaches the loop on the way to the point of use. The entire loop system is peri­od­i­cally and auto­mat­i­cally sani­tized with ozone.

    Is water analysis always neces­sary and which values are impor­tant?

    Yes. Every process stage used has certain oper­ating para­me­ters which must be followed. This is impor­tant to ensure the expected product quality as well as a long service life for the system and the compo­nents. Are fluc­tu­a­tions expected with the feed water, such as through seasonal fluc­tu­a­tions or different sources of supply, or even several? For this reason, every design of a perfect system starts with metic­u­lous and complete water analysis.

    This is why the total and compo­si­tion of the various compo­nents is so impor­tant. On occa­sion, these cause reci­p­rocal effects in the process tech­nology. Chlo­rine, silica, iron, hard­eners, suspended sedi­ments, micro­bi­ology, dissolved gases, the silt density index, and temper­a­ture are always extremely impor­tant.

    Is a large system with high levels of output more future-​proof?

    To start with, the whole system covers treat­ment, storage, as well as distri­b­u­tion. It must be holis­ti­cally consid­ered and correctly propor­tioned. Expe­ri­ence shows that treat­ment systems are frequently too large and rarely too small. This phenom­enon is often observed in the start-​up phases.

    The conse­quences include long periods of down­time and short periods of running time, which put exces­sive load on the compo­nents. Micro­bi­o­log­ical risk increases due to standing water during the periods of down­time. A circular flow oper­a­tion is an emer­gency solu­tion at best in both proce­dural and finan­cial terms.

    For this reason: Clear consump­tion analysis and correct design are impor­tant from the start. Frequently: It is usually better to have a smaller gener­ator that runs constantly in the start-​up phase and provide it with a larger tank. Output can be adjusted later either via expan­sion or a redun­dant unit.