MemGEN™ Water Generation System

The MemGEN water generation solution is a pre-engineered high purity water system that uses dechlorination, ultraviolet (UV) disinfection, reverse osmosis (RO), and continuous electrodeionization (CEDI) and optional ultrafiltration to provide Purified Water (PW) or Water for Injection (WFI) for pharmaceutical customers. 

The MemGEN solution is engineered for end-to-end process efficiency, integrating regulatory design expertise to ensure compliance with global pharmacopeia standards as a standard system eliminating time consuming and costly specification development and evaluation. We have also streamlined the quoting, installation, and service process for faster delivery and ease of operation.

Yes, the pretreatment, system operations and configured nature of the MemGEN design can be adjusted to handle differing feed water conditions. Through its extensive, best-in-class engineering design, the MemGEN generation system can adapt system operation to maintain required water quality and production capacity across a wide range of incoming water conditions.

MemGEN was designed to meet or exceed the USP Monograph Water Quality Requirements for Purified Water (PW) or Water for Injection (WFI) as well as other global standards.

The MemGEN solution is engineered specifically for GMP-regulated environments and supports both cGMP and 21 CFR Part 11 compliance. It does this through a hygienic design, controlled repeatable processes, full traceability/documentation, and alarm/deviation management. The enhanced software package for setpoint change audit trail enables the user a viewable log of changes to key setpoints that are recorded for traceability.

Each system undergoes a rigorous Factory Acceptance Test and includes comprehensive validation documentation formatted per GAMP 5 requirements guidelines.

Validation documentation supplied with every unit

• Signed Factory Acceptance Test (FAT) (Non-Witnessed)
• Site Acceptance Test (SAT)
• Installation Qualifications (IQ)
• Operation Qualifications (OQ)
• Performance Qualifications (PQ)
• Functional Requirement Specifications (FRS)
• Detailed Design Specifications (DDS)
• Software Design Specifications (SDS)
• QA test records
• Material & Instrument calibration certs from manufacturer
• Instrument calibration documents from manufacturer
• Video boroscoping of sanitary manifolds (10% w/ minimum of one weld per manifold assembly)
• Pre-RO membrane tubing (non-validated manifolds):  material certifications, surface finish certificate of conformation.
• Post RO membrane tubing (validated manifolds): weld maps, welder certifications, weld procedure qualification, passivation certificate, surface finish certificate
• Equipment list, (Input/Output) I/O list
• Human-Machine Interface (HMI) screen prints
• Witnessed Factory Acceptance Test

MemGEN comes equipped with an Allen Bradley Compact Logix Programmable Logic Controller (PLC) and a Panelview Plus HMI touchscreen. MemGEN can be equipped with Link2Site for 24/7 remote monitoring.

The MemGEN solution reduces microbial risk with multiple microbial barriers and thermal sanitization.

The MemGEN water generation solution is designed for enhanced lifetime value with durable, high-quality components and ease of operation and maintenance. MemGEN’s Ionpure® CEDI modules are a lifecycle advantage compared to competitive electrodeionization modules that are often replaced every 1-2 years at a high cost. When paired with Xylem’s sustained treatment expertise, remote monitoring capabilities via Sophis™ digital services, experienced service personnel, and robust system engineering. This integrated approach enables continuous performance optimization, extending system lifecycle and reducing total cost of ownership by optimizing each treatment technology for maximum consumable life.

By prioritizing technologies such as pumps with integrated variable speed drives, high-efficiency UV systems, and three operating modes (high recovery recirculation and start-stop) including the system can be tuned to each facility’s unique requirements. This flexibility pre-engineered into the MemGEN solution helps strike the right balance between energy consumption and water usage.

Xylem provides technical support like remote troubleshooting, online video tutorials, on-site inspections, and dedicated technical support hotlines. Support options include programs for specific equipment like MemGEN, as well as more comprehensive service platforms like Evoqua's Water One service platform. Paired with our extensive branch network across the U.S., this enables Xylem to serve as a true partner for both equipment manufacturing and technical service expertise.

Commissioning & startup

Xylem will demonstrate that the system is operating in accordance with its design specifications, including providing IQ, OQ, and SAT execution with a Turn Over Package and/or onsite operating data. We will also support the customer with training and other resources to ensure successful equipment and project handoff.

Water One® Services

Water One® Services is a revolutionary digital water management solution with 24/7 remote monitoring that combines Xylem’s water expertise, proactive and comprehensive service, proven technology, and data intelligence. It keeps your water treatment system fully optimized by using smart technology to drive efficiency in both operation and service. Taking water management off your hands so you can stay focused on your core business objectives.

Maintenance contracts

Xylem offers maintenance contracts that are cost effective service agreements tailored to meet your specific requirements and budget. Xylem also has local AquaPros on-call 24/7 to support emergencies after hours for our customers.

Equipment repair & refurbishment

Xylem offers fast, reliable onsite repair services at your facility to minimize downtime and get out-of-service equipment back up and running quickly.

Membrane cleaning and exchanges

For Xylem customers who have membrane-based treatment systems on site, we offer membrane cleaning services. We can clean existing membranes onsite or offsite and provide any necessary membrane changeouts.

Shutdown, turnaround & outage

Xylem has extensive experience managing shutdown and turnaround projects, using a wide range of mobile and temporary solutions to support large, planned maintenance activities. It is important to note that trailers are most effective for source water for CIP skids, utility, and some other non-compendial water specifications.