water Clean.
watts Green.
waste Lean.
USP WATER
“USP water” is the subject of an official monograph in the current US PHARMACOPEIA. Several different grades of water used for pharmaceutical purposes are described in the USP monographs. These waters can be divided into two general types: “bulk” waters, which are typically produced on-site where they are used; and “sterile waters”, which are produced, packaged, and sterilized to preserve microbial quality throughout their packaged shelf life. specifications for each type.
Standards
The monographs for bulk waters include:
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Purified Water (PW)
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Water For Injection (WFI)
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Water for Hemodialysis
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Pure Steam
The USP PW and WFI are components or "ingredient materials" intended to be used in the production of drug products. USP WFI can only be produced by distillation or reverse osmosis.
The quality of the water produced must meet the following requirements in accordance with latest edition of the US Pharmacopoeia specified by parameter:
The quality of the water produced will meet the following requirements in accordance with latest edition of the US Pharmacopoeia specified by parameter:
The European Pharmacopoeia (Ph Eur) has similar requirements with added specifications for nitrates and heavy metals:
What We Do
w3Synergy designs and fabricates the water treatment equipment required by the pharmaceutical and biotech industry. w3Synergy systems are fully-automated, self-cleaning by recirculating highly purified water that can be heated for sanitization. Automated hot water sanitization sequence eliminates the need for chemical sanitization or a separate CIP skid.
A USP water system engineered by w3Synergy can be defined as a treatment train comprised of an array of separation technologies. The process steps specifically used for USP water are categorized as follows:
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Media Filtration
Chlorine, chloramine, and bromine are disinfectants used in waters supplied by municipalities. Granulated activated carbon (GAC) media is typically used to remove these types of organics from the water. GAC is also an effective method of removing manmade chemicals such as per- and polyfluorinated substances (PFAS).
“Softener” media containing ion exchange (IX) resin is used for surface waters containing high levels of hardness (caused by the presence of calcium and magnesium ions). Selective IX resin is also available to remove PFAS.
Microfiltration
w3Synergy provides cartridge and bag filtration with pore sizes ranging from 1 micron to 5 microns in the pretreatment stages and 0.2μm absolute at the final treatment stages.
Membrane Filtration
W3Synergy fabricates a broad range of membrane filtration equipment including ultrafiltration, nanofiltration, and reverse osmosis.
Ultrafiltration is used to remove suspended solids (TSS), colloidal material, and removal of bacterial endotoxins and nucleases.
Reverse osmosis is used to lower the level of total dissolved solids (TDS) in supply water due to the presence of ions, salts, and minerals found in the water. The TDS as measured in parts per million (PPM) will vary in the supply water seasonally and geographically. Conductivity expressed as microsiemens per centimeter (uS/cm) is another method of monitoring the presence of these dissolved solids.
RO membranes can reject bacteria, pyrogens, and some organic solids as well.
Double-pass RO, where the product (permeate) from the first pass of the RO is further purified using a second (pass) RO, is available to further decrease the conductivity of the water.
Full-fit, hot water sanitizable RO membranes remove greater than 99% of the dissolved solids/ions (TDS) from the feed water. RO membranes are heat set at 85oC at the factory ready for use.
w3Synergy beverage systems utilize the latest energy-saving low pressure RO membranes along with variable-frequency drives on our pump motors. To reduce the use of supply or makeup water, w3Synergy skids incorporate integrated concentrate recovery which cuts in half the quantity of brackish water discharged to the sewer.
Electro- Deionization
The EDI process uses a combination of ion-selective membranes and ion-exchange to remove ions remaining in the RO permeate to the desired target of <1.3 µS/cm. The EDI stack is designed for hot water sanitization.
Energy-efficient power supply for the EDI stack operates under constant voltage allowing the current to fluctuate for optimal control of the EDI process.
In source waters containing elevated dissolved carbon dioxide, a membrane contactor degassifier may be used upstream to enhance the effectiveness of DI or EDI in the presence of dissolved carbon dioxide.
Disinfection
After the water has been filtered, disinfection is an additional method used to kill any remaining pathogens including parasites, bacteria, or viruses.
Ultraviolet light (UV) can eliminate trace organics at 185nm and inactivate microorganisms at 254nm. The oxidation of trace organics results in pure water with low TOC levels
Treated Water Storage and Distribution
w3Synergy fabricates custom-designed Storage & Distribution Systems specific to our clients’ needs and requirements. The components of these systems typically include Product Storage Tank, Distribution Pump, and Disinfection Loop.
A UV sterilizer provides disinfection of pathogens and is sized based on the desired rate of circulation through the loop. A 0.2μm absolute filter is included in the loop.
Clean-In-Place
w3Synergy fabricates both pre-engineered and custom-designed CIP skids for periodic cleaning of RO membrane systems, process & storage tanks, piping, and/or fermentation reactors. The chemical tanks and pumps on the skid are sized consistent with the application.
Monitoring & Automation
w3Synergy UPW water treatment systems are fully automated with the option of either Allen Bradley, Siemens or Idec PLC. Automation allows for remote continuous online monitoring & control.
Available on-line instrumentation includes:
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UV intensity monitor
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TOC analyzer
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Bioburden
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Chlorine
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pH
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ORP
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Conductivity
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Resistivity
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Turbidity
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Pressure
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Flow
Contact Us
w3Synergy is ready to help you with your next water purification or water reuse project.
Contact our engineering team to learn more:
858.215.4122