The purified water/water for injection(WFI) combined distribution system is a kind of equipment integration device, which can fully convert and utilize resources and energy, greatly reduce production costs, save equipment floor space, and reduce equipment investment costs. At the same time, wfi skid can integrate the operation control system of the equipment, and the flow picture of the wfi skid equipment can be freely switched and selected on the same operation interface.
◆ The wfi skid has no stagnant conditions and areas of low flow rate.
◆ The wfi skid has temperature control.
◆ The wfi skid has proper slope of the pipeline to ensure drainability.
◆ Stainless steel surface finish with appropriate roughness in order to avoid nutrient and biofilm accumulation.
◆ No deadlegs area of the wfi skid.
◆ Periodic sanitisation or sterilisation of the storage tank and loop.
◆ The wfi skid has storage tank protected with 0.2 micron hydrophobic vent filter.
◆ Sufficient instrumentation and monitoring equipments.
Water for Injection (WFI) is a pharmaceutical grade of water that is used in the preparation of sterile medications, particularly those that are administered via injection or intravenously. It is produced under highly controlled conditions to ensure its purity and sterility, meeting the standards set forth by regulatory agencies such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.).
Water for Injection must meet stringent requirements regarding its chemical composition, microbial content, and endotoxin levels to ensure it is suitable for use in pharmaceutical applications. It is essentially water that has been purified through processes such as distillation, reverse osmosis, or ultrafiltration, and then subjected to further treatment and testing to ensure its quality and safety for use in healthcare settings.
The primary purpose of Water for Injection is to serve as a solvent or diluent for pharmaceutical substances, allowing for the preparation of sterile solutions or suspensions for injection. It is also used in the manufacturing process of various pharmaceutical products, including parenteral (injectable) medications, intravenous fluids, and medical devices.
◆ High Purity: The Biocell WFI skid ensures the production of water with exceptionally high purity levels, meeting or exceeding regulatory standards. This purity is crucial for the preparation of sterile medications and intravenous solutions.
◆ Consistent Quality: The skid is designed to provide consistent quality of WFI, minimizing variability in the water used for pharmaceutical manufacturing processes. This consistency helps ensure the reliability and reproducibility of pharmaceutical products.
◆ Compact Design: The skid is compact and space-efficient, making it suitable for installations where space is limited. Its compact design also simplifies transportation and installation, reducing overall costs and logistical challenges.
◆ Easy Integration: Biocell WFI skids are designed for easy integration into existing pharmaceutical manufacturing systems. They can be seamlessly integrated with other equipment and processes, allowing for smooth operation and minimal downtime during installation or upgrades.
◆ Compliance: The skid is designed and manufactured in compliance with relevant industry regulations and standards, such as those set forth by regulatory agencies like the FDA and EMA. This ensures that pharmaceutical manufacturers can confidently use Biocell WFI skids in their operations while meeting regulatory requirements.
Distilled water and Water for Injection (WFI) differ mainly in purity and intended use. Distilled water is produced by boiling and condensing steam, removing many impurities, and is used in labs, cleaning, and household appliances. However, it doesn’t meet the stringent standards required for medical applications.
WFI, produced using specialized Water for Injection machines, undergoes advanced purification processes like multi-stage distillation or reverse osmosis followed by distillation. It must meet strict pharmacopeial standards (USP, EP) for conductivity, Total Organic Carbon (TOC), and microbial content, ensuring it is pyrogen-free. WFI is essential for pharmaceutical and medical applications, such as preparing injections and cleaning equipment, where the highest purity is critical.
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