Hot Water Sanitation Pharmaceutical Used Pre-Treatment System
Hot Water Sanitation Pharmaceutical Used Pre-Treatment System
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Pre-treatment system provided good quality influent water for Reverse Osmosis system.
Remove the particles that could damage Reverse Osmosis membrane
Remove calcium and magnesium ions to avoid incrustation
Remove calcium and magnesium ions to avoid incrustation
Choose excellent ductility and toughness SUS316L stainless steel as the water tank material, and select a heat-resistant control valve that is resistant to temperatures of 80 °C.
Hot Water Sanitation Reverse Osmosis System Water Purification System
Hot Water Sanitation Reverse Osmosis System Water Purification System
Reverse osmosis (RO) membranes are capable of removing up to 99% of dissolved salts from raw water. They also provide an effective barrier against bacteria and organic contaminants, ensuring high-purity water suitable for a wide range of applications.
The double-pass RO system is designed in compliance with the standards set by international pharmacopeias, ensuring suitability for pharmaceutical-grade purified water production.
The concentrate (reject water) from the first-stage RO is fully discharged, while the concentrate from the second-stage RO is recycled back into the process. This design effectively increases the overall water recovery rate of the system.
Based on customer requirements, the system is equipped with a circulation mode during standby periods to prevent bacterial growth caused by stagnant water and to minimize wastewater discharge.
Hot Water Sanitizable Continuous Electrodeionization (CEDI) System
Hot Water Sanitizable Continuous Electrodeionization (CEDI) System
The CEDI process operates by applying a direct electric field across the module to separate positive and negative ions in the water. These ions are then selectively removed through ion-exchange membranes, producing low-conductivity deionized water continuously and without the need for chemical regeneration.
The RO + CEDI deionization system delivers ultra-low conductivity water and serves as an effective alternative to traditional double-pass RO systems.
The CEDI system utilizes a recirculation control design to stabilize water quality at high resistivity levels while minimizing resin fatigue and fouling. This not only enhances operational stability but also extends the lifespan of the module by up to 2 times compared to standard operation.
製Purified Water (PW) & Water for Injection (WFI)
Pharmaceutical-grade water is classified into various quality levels based on its intended use. According to the United States Pharmacopoeia (USP), Water for Pharmaceutical Purposes is the primary standard, supported by guidance from the U.S. Food and Drug Administration (FDA) on high-purity water system inspections.
From both chemical and microbiological perspectives, this discussion explores the performance evaluation of purified water systems used in pharmaceutical manufacturing. It also addresses the design considerations and potential challenges associated with different purification units. Relevant background information and evaluation criteria are provided to assist in assessing the suitability and compliance of pharmaceutical water systems.
Microbial control is the primary concern in pharmaceutical water systems. The design of the production, storage, and distribution components must prevent microbial contamination and the formation of endotoxins.
Regular sanitization and microbiological monitoring are essential. Therefore, system design must incorporate features such as no dead legs in piping, complete drainability during shutdown, and hot water sanitization loops. In addition, the system must be supported by comprehensive validation documentation to ensure full compliance with regulatory requirements.
Based on water quality requirements, pharmaceutical water is generally classified into the following categories:
Purified Water (PW): Used as an ingredient in the formulation of pharmaceutical products, as well as for cleaning equipment and in the production of active pharmaceutical ingredients (APIs).
Water for Injection (WFI): Used as a raw material for injectable preparations, and also for cleaning certain pharmaceutical equipment and in API manufacturing.
All pharmaceutical-grade water must meet stringent limits for ionic and organic chemical purity, and systems must be designed to prevent microbial growth.
Potable water is typically used as the feed source, which is then treated using deionization, distillation, ion exchange, reverse osmosis, filtration, or other appropriate methods. The purified water system must be fully validated to ensure compliance with regulatory standards.
Our company has proven experience in PIC/S GMP-compliant pharmaceutical projects, delivering advanced water treatment technologies and equipment for both domestic and international clients.
We offer customized system design based on specific water quality requirements, supported by a professional and experienced team for facility construction and after-sales service.
Comprehensive validation documentation and test reports are provided to support clients in achieving DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
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