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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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Purified water requirements

Ph. Eur. & USP

Pharmacopeias 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 Phar­ma­copeia (USP) and the Chinese Phar­ma­copeia (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
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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 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.

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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.

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
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Septron

STERITRON

The crit­ical micro­bi­o­log­ical tank must be under control to ensure that PW is safely stored. This is ensured with elec­trolyt­i­cally gener­ated ozone directly from Puri­fied Water, without addi­tives. The result is effi­cient, cost-​effective and contin­uous sani­tizing of the ware­house and distri­b­u­tion system.

  • Extremely effec­tive germ reduc­tion
  • Cost-​effective instal­la­tion & oper­a­tion
  • Simple instal­la­tion, commis­sioning & oper­a­tion
  • Contin­uous tank and regular auto­mated loop sani­ti­za­tion
  • Envi­ron­men­tally friendly.
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Pharma

BEWADES UV

Disin­fects Puri­fied Water and removes ozone until it is below the detec­tion limit. Specially designed for the pharma industry—316 L stain­less steel for parts that come into contact with the media, elec­trop­o­l­ished with rough­ness < 0.5 μm

  • Safe ozone reduc­tion
  • Effi­cient PW disin­fec­tion
  • Low oper­a­tion & main­te­nance costs
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Bewades UV

SEPTRON BioSafe

Puri­fied Water with enhanced micro­bi­o­log­ical safety: The SEPTRON EDI module with inte­grated final ultra-​filtration membrane. Welcome to the future of PW gener­a­tion.

  • Maximum safety
  • Highest yield
  • Minimum foot­print
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Septron

AQU@Sense MB

Micro­bi­o­log­ical quality of Puri­fied Water at a glance at all times. Simply reli­able. The flow cyto­metric process delivers impres­sively accu­rate results.

  • Online or offline measure­ment
  • In-​depth analysis option for micro­bi­ol­o­gists
  • Prompt status infor­ma­tion & reac­tion option
  • Reli­able counting of all cells, not just colonies
  • Simple data transfer for system inte­gra­tion
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Aqua Sense

Advice

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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.
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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.

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