A well-designed generation system based on the requirements of actual processes is critical to reliable pharmaceutical water supply.
WEMAC provides purified water (PW) and water for injection (WFI) generation systems that can be customized and configured according to source water quality, required capacity, product water quality, sanitization method, and site conditions. The water generation systems, using pharmaceutical water treatment technology, hygienic design, and automated process control, are suitable for establishing new production facility, increasing production capacity and upgrading existing system. The water generation systems help pharmaceutical, biopharmaceutical, and other companies with reliable and efficient high-purity process water supply.
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Purified Water System
(PW Generation System)The purified water (PW) generation system uses advanced reverse osmosis technology to remove impurities, bacteria, viruses, and other harmful substances from feed water.
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Water for Injection System
(WFI Generation System)Water for injection (WFI) is pharmaceutical-grade water that complies with the requirements specified in the relevant pharmacopoeia.
During the initiative stage, we determine system boundaries and technical approach based on source water analysis, product water quality, required system capacity, point-of-use requirements, operating strategy, site conditions, and applicable standards specified by the clients.
We provide project-specific configurations of purified water, water for injection, pure steam, storage and distribution, and related process systems. And accordingly we complete the design of main equipment, piping, instrumentation, controls, and connecting parts.
The manufacturing and integration of key equipment, hygienic piping, process skids, and control systems take place at WEMAC’s pharmaceutical equipment manufacturing facility.
The pharmaceutical equipment manufacturing facility covers an area of 61,700 m2 and is equipped with sheet metal processing, automated welding, waterjet/plasma cutting, CNC machining, and related inspection equipment. The manufacturing facility enables manufacturing, assembly, and system integration of pharmaceutical water equipment and systems.
For equipment and hygienic piping that directly contacts product water, we can conduct automated and orbital welding, surface treatment, pickling and passivation, as well as associated inspection and documentation depending on the project requirements.
For production inspection and quality control, we use methods such as spectroscopic analysis, borescope inspection, surface roughness measurement, and non-destructive testing (NDT) to help ensure quality control and traceability throughout material handling, welding and equipment manufacturing.
316L stainless steel, other key materials and purchasable components can be provided with associated documentation detailing material, inspection and calibration.
Before the delivery, the water treatment systems can undergo system assembly, control function checks and factory acceptance test within the specified limits at the equipment manufacturing facility.
The specifics of factory acceptance test are determined according to project user requirements specification (URS) and acceptance plan agreed upon by both parties and may involve verification of equipment integrity, control logic, instrumentation, pressure and leak tightness, operation functionality, and associated documentation. The client can choose on-site or remote acceptance based on project schedules.
For projects requiring overseas delivery, we provide export packaging, technical documentation, installation and commissioning support according to agreed terms.
Our engineers can provide on-site support including completing or supervising equipment positioning, system connection, start-up and commissioning, operation checks, operator training, and assistance in site acceptance test (SAT).
Electrical systems, control interfaces, technical documentation, and selected system configurations can be customized based on project country, site conditions and client’s requirements.
For pharmaceutical projects, we provide design, manufacturing, testing, installation, and operation documentation related to equipment and system delivery based on agreed terms and the client’s requirements. During verification, we assist the client with their needs.
We also provide complete English documentation package covering DQ, IQ, OQ, and PQ, and have supported multiple clients in verifying the compliance with the FDA and GMP. We can provide related electronic records like FDA 21 CFR Part 11 and audit trails during on-site inspection guided by GMP or local drug regulatory requirements.
We also provide simplified operation manual in local languages.
After the water treatment system is put in operation, WEMAC continue to provide remote technical support, on-site support, spare parts and consumables supply, maintenance guidance, and related technical documentation to help ensure continuous reliable operation of the pharmaceutical water system.
- Remote technical support: response time within 4 business hours
- Emergency spare parts supply: international express shipping via DHL/FedEx
- Consumables change: We provide timetables for changing filter cartridges, membrane elements, UV lamps, etc.
- Scheduled follow-up: We follow up on system operation every 6-12 months.
- Documentation support: multilingual operation manuals, validation documentation, and as-built drawings