Questions You Should Know about purified water generation system

The Importance of Asking Key Questions

When selecting a pure water system for your industrial needs, making an informed choice is crucial to ensuring both operational efficiency and cost-effectiveness. With various technologies and solutions available, it can be overwhelming to determine which system best suits your requirements. To simplify this process, focus on two key questions when selecting a pure water system. Addressing these questions will guide you in selecting the optimal system for your business.

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What Is the Quality of Water You Need?

One of the key questions to ask when selecting a pure water system is, “What is the quality of water you need?” Understanding the specific water quality needed for your applications is crucial when selecting the right purification system. It’s essential to consider how you will use the water and whether it must meet specific quality standards.

• Application Requirements: What is the intended use of the water in your business? Different applications have varying water purity standards. For example, pharmaceutical manufacturing may require high purity water according to ASTM standards, while general industrial applications might have less stringent requirements.

What Is the Quantity of Water You Need?

The other key question to ask when selecting a pure water system is, “What is the quantity of water you need?” The quantity of water required is another crucial factor that impacts the choice of a pure water system. Assessing your water usage needs involves considering:

• Flow Rate: What is the volume of water you require per unit of time? Systems are designed to handle different flow rates, so selecting one that matches your consumption patterns is vital for continuous operations without interruptions.
• Peak Demand: What is your maximum water demand during peak usage times? A system should be capable of handling these peak demands to avoid any downtime or production delays.

The Importance of Choosing the Right Pure Water System

Choosing the right pure water system begins with a clear understanding of your water quality and quantity needs. By addressing these key questions —what is the quality of the water you need, and what is the quantity of water you need—you can make an informed decision that ensures your water treatment system meets both your operational requirements and industry standards.

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19. What are the most common issues encountered in the WFI production systems produced under GMP. What should we look for?

1. One common problem is where there is a cold WFI sub-loop off of a heated system with a large shell and tube heat exchangers used for cooling in that sub-loop. When the sub-loop is hot water sanitized, not enough contact time is allowed for the cooling heat exchangers (and their trapped chilled water) to get them thoroughly hot and sanitized. When incompletely sanitized, any surviving biofilm will immediately reinoculate the cold sub-loop after resumed cold operation and be present as detectable micro counts.
2. Other common problems with cold WFI systems are dead legs, sometimes temporary ones that are created by open hard-piped connections to equipment that is not in use and not drawing water. The hot water during sanitization doesn’t mix well with the trapped water in that dead leg, so the dead leg never gets sanitized. If there was any contamination that got into that side leg during previous use, it will grow unabated in the unsanitized dead leg and continuously contaminate the loop water.
3. Another common problem is overwhelming the distillation purification process with a high level of endotoxin in the water going to the still (100+ EU/mL). This can happen with poor maintenance of pretreatment unit ops such as carbon beds, and also when coincident with high endotoxin levels in the city water when they switch over to straight chlorine from chloramine for a part of a year.

False

22. When sampling water ports should we hook up process hoses?  Is this a requirement or a recommendation?

1. If the sampling is for QC “release” of the water for manufacturing use, then the outlet used by manufacturing must be sampled in EXACTLY the same fashion as it is used by manufacturing – same outlet sanitization (if any), same manufacturing hose (no matter how grungy or poorly maintained), same pre-flushing (if any), same everything. The purpose of the sample data is to duplicate the same quality of water that manufacturing is using, so you have to duplicate in sample collection how the water is drawn from the system for use. Those procedures of water use can significantly contaminate pristine water within a water system when it exits, so that “nasty” water is delivered to a manufacturing operation. If you sample the water differently (better) than it is used by manufacturing, you will get lower (better) micro counts that are not representative of the water quality that is actually be used. Sampling like manufacturing water use for QC release is required by FDA to be identical. If it is not, this could earn you an FDA483 observation or worse.
2. If the water is being sampled for process control (PC) for the purpose of water system monitoring and systemic microbial control, it might be done through sampling ports that are not used by manufacturing. Since we know that the outlets themselves can contribute to the bioburden of the collected water, extreme efforts can be used to assure that the outlet does not add to the microbial content of the water as it exits the system (using extreme outlet sanitization, very vigorous and thorough flushing, sterile hoses, etc.). For PC, you are interested in the quality of the water within the system behind the valve and do not want contamination in a sampling port to bias the interpretation of the data.
3. However, water collected from sampling ports (rather than manufacturing use outlets) usually cannot be used for final release (QC) of water since it is not collected in the manner it is actually used. Manufacturing does not generally use water drawn from sampling ports.

False

23. What is your risk in increasing endotoxin levels due to the different sanitization methods?

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1. Endotoxin levels are typically a concern only for WFI systems. Most WFI systems are sanitized by elevated temperatures (hot water is better than steam since no special engineering is needed for hot water sanitization and it is plenty adequate), though more may employ ozone in the coming years as ambient non-distillation purification technologies become more widespread with EP’s relaxation of the methods of preparing WFI in their WFI monograph. Since thermal or ozone sanitization of WFI systems is typically no less frequent than weekly, that is not enough time for biofilm (with its endotoxin) to develop in the system and be released by periodic sanitization.  If the systems are much less frequently sanitized, there is a chance that developing biofilm could release detectable endotoxin when killed by periodic sanitization.
2. If chemical sanitizers other than ozone are used (this would be very atypical for a WFI system or an endotoxin-controlled Purified Water system), the sanitizer would have to be rinsed out, which would also rinse out any released endotoxin.

False