WFI WATER FOR INJECTION, HERE IS SOME EXPLANATION.

BRAM-COR S.p.Ais a leading company in customized pharmaceutical equipment manufacturing and in biopharmaceutical turnkey plants. Its target in design, testing and validation activities focuses on the overall compliance of the equipment to the needs of pharmaceutical industry. For this reason, BRAM-COR is the sponsor of “wfi-waterforinjection.com”. In this regards, our site clarifies some aspects related to the use of WFI Water for Injection and grade waters, specially to produce IV fluids and parenteral solutions. Although the correct water treatment system is the basis for the final quality of any pharmaceutical solution, there are factual differences of evaluation regarding the choice of technologies. 

WATER FOR INJECTION DEFINITION, THIS IS THE QUESTION!

What WFI Water for Injection means in Europe rather than in Japan or US? Which one is better between vapor compression or multiple effect distillation? Reverse osmosis systems can produce cold WFI? There are differences between sterile and bacteriostatic wfi? What are the values of reverse osmosis, ultrafiltration or UV treatment? All these technologies are part of our core business, so these pages offer a concrete knowledge of the leading considerations in pharmaceutical field. We hope to be useful not only for our customers, but also for the many students asking us questions about the different grades of water used in biotechnologies and in pharmaceutical applications.

WFI WATER. THE ROOTS OF BRAM-COR EXPERTISE

To produce WFI-Water for Injection you need a distiller; USP admits also “a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms” (like Reverse Osmosis coupled with electro-deionization, nanofiltration and, downstream, ultrafiltration). Going to visit our main web site (bram-cor.com), you can discover BRAM-COR expertise in many types of pharmaceutical equipment, from water treatment to processing and filling. Therefore WFI equipment manufacturing starts from those International Good Manufacturing Practices (cGMP) that are common to all BRAM-COR machinary.  It must be also considered that all the different Pharmacopoeias in the world are the baseline to BRAM-COR work. So, we have an infinity of customizations. Furthermore, we proudly remark that our equipment is entirely manufactured and customized in Italy. In fact, BRAM-COR experience and passion for stainless steel processing enable to care for quality in details. Moreover, energy saving concerns, sanitary quality and certifications, long-term reliability are a rule for BRAM-COR distillers and water treatment systems. On the map below you can see where the BRAM-COR systems work.

 

 

 

THE CHOICE OF SANITARY MATERIALS

In this composite outlook, special care is given by BRAM-COR to the choice of sanitary materials. So, product-contact surfaces are in certified AISI 316L stainless steel, with standard roughness, while EPDM or PTFE gaskets ensure perfect sealing. Moreover, advanced process analytical technologies are applied for monitoring issues and professional GAMP compliant automation is provided for system control. Naturally, any kind of pre-treatment options, monitoring of critical parameters, regulatory requirement for product quality, consumptions, microbiological control, operation and maintenance requirements, lifecycle costs are key points in our design of all processing steps, from feed water to the point of use.

 

Direct link to BRAM-COR main site for specific equipment to produce pharmaceutical waters:

PRTW Water Pretreatment System

CROS Reverse Osmosis System

STMC Vapor Compression Distiller

SMPT Multiple Effect Distiller

CPSG Pure Steam Generator

DPSG Single Effect Distiller

GENO Ozone Generator

LOOP Distribution System

SCADA Control System

DTS Heat/Cool Exchanger

STOC Storage Tank

KOMB WFI + PS Generator

STDA Standard Accessories & Components

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