|Design, Qualification, and Performance of a Cost-Effective Water Purification System for a GMP Pilot Plant
Joseph Tunner, George Katsoulis, Jeffrey Denoncourt, and Sean Murphy; Reprinted from PHARMACEUTICAL ENGINEERING�� The Official Magazine of ISPE, July/August 2006, Vol. 26 No. 4
Reprinted from PHARMACEUTICAL ENGINEERING�� The Official Magazine of ISPE, July/August 2006, Vol. 26 No. 4 2006
|Water Purification Technologies and Silica Breakthrough
American Laboratory News April 2002
The presence of silica in ultrapure water has long been recognized as an issue in several areas of research and routine testing. In particular, applications in the microelectronics industry are particularly known for their sensitivity to silica, but instruments such as weatherometers, autoclaves, and clinical analyzers also require silica-free water to avoid instrument defection and erroneous results. Hence, the avoidance of silica in the final purification system should be a basic and primary concern. It is therefore extremely important to have a well-designed pretreatment system to remove the bulk of silica and to avoid silica release. While some pretreatment methods and systems are very efficient in removing silica, others have a low efficacy due to the materials used or to system misuse. The most widely used water purification technologies are deionization (DI), reverse osmosis (RO), and electrodeionization (EDI). Their effect on and pertinence for silica removal are discussed in terms of silica chemistry and behaviour under different conditions in this paper and comparative data is presented for these three purification technologies.
RiOs™ systems are ideal for laboratories needing reliable production of Reverse Osmosis, RO (Type 3) water from potable tap water. RO pure water produced by RiOs™ systems is ideal for non-critical laboratory applications, such as:
- Glassware rinsing
- Water baths
- Feed water for humidifiers, autoclaves, glassware washers, washing machines
- Feed water for ultrapure water systems
Systems are available in 30, 50, 100, 150 and 200 liter models to match the specific volume needs of your laboratory. They can provide up to 8000 L of RO water per day. RiOs™ can be integrated into a centralized system, providing total control of all parameters within the system itself as well as within the external pure water distribution loop.
RiOs™ water • Intelligent purification
RiOs™ is built on an optimized and efficient purification sequence: Tap water first enters the Progard® pretreatment cartridge which efficiently removes particles & colloids, free chlorine and hardness. Pretreated water passes through the reverse osmosis membrane which removes up to 99% of all ionic & organic contaminants, microorganisms and particles. The benefits of RiOs™ intelligent reverse osmosis are:
- No risk of water shortage, even in winter – intelligent RO adapts its production rate to tap water temperature (7-30°C).
- Continuously, high quality RO permeate – intelligent RO is always working to the best of its ability, discarding primary low-quality permeate, protecting downstream purification technologies.
- Environment conscious, water savings – intelligent RO optimizes the recovery of rejected water and in turn maximizes Progard® lifetime.
One complete purification and control unit
System provides total control of all functions, operating parameters and standard accessory components within the unit itself and on the external pure water distribution loop.
- Built-in UV lamp for bacteria-sensitive applications
- Easy-to-replace pretreatment packs, tailored to the feed water source
- Built-in conductivity monitoring to ensure water quality
Advanced support & validation
A complete range of Services, including Validation support, is provided by certified Field Service Engineers using calibrated equipment and Qualification Workbooks. For full confidence in your RiOs™ system, it is delivered with a Certificate of Calibration for the built-in temperature and resistivity meters, and a Certificate of Conformity ensuring that it has been built and tested fully assembled following internal Standard Operating Procedures. The manufacturing site is ISO® 9001 v.2000 and ISO® 140001 certified.
RiOs™ Large RO water (Type 3)
|Ionic rejection||> 95 %|
|Organic rejection for MW > 200 Dalton||> 99 %|
|Particulates rejection||> 99 %|
|Bacteria||< 10 CFU/mL|
|Production flow Rate||30 L/h (RiOs™ 30)
50 L/h (RiOs™ 50)
100 L/h (RiOs™ 100)
150 L/h (RiOs™ 150)
200 L/h (RiOs™ 200)
|water quality||Potable tap water|
|Feed water conductivity at 25°C||< 2000 µS/cm|
|Feed water pressure||2 - 6 bar|
|Feed water temperature||5 - 35°C|
|Feed water chlorine||Application Specialist will determine pretreatment required|
|Feed water fouling index||Application Specialist will determine pretreatment required|
|Feed water pH||4 - 10 pH units|
|Feed water connection||½ in Gaz M|
|Dimensions (H x W x D)||734 x 662 x 441 mm (28.9 x 26.1 x 17.4 in)|
|Operating weight||33 - 40 kg (72.8 - 88.2 lb)|
|Data port connection||RS232|
RiOs™ systems are tested by an independent and accredited company for compliance with the CE directives related to safety and electromagnetic compatibility. The report can be consulted on demand. RiOs™ systems are built using components and practices recommended by UL and have been cUL marked. The registration can be verified on the UL web site ( http://www.ul.com).