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. |
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.
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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.