BRAM-COR SpA - Via Mercalli 12/A - 43122 Parma - Italy info@bram-cor.com +39 0521 538711

WATER FOR INJECTION (WFI) SYSTEMS

Our site clarifies some aspects related to the use of Water for Injection and other pharmaceutical grade waters, specially to produce IV fluids and parenteral solutions. When a water complies with the pharmacopoeias requirements is called compendial water. 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 to produce each compendial water.

Water for Injection definition

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. To discover all types of pharmaceutical water in this website: WFI and compendial waters in pharmacopoeias

Bram-Cor water Treatment Room

Water for Injection Systems

Water For Injection can be produced through distillation or through a downstream unit of ultrafiltration in a Reverse Osmosis system. Therefore, to produce Water for Injection (WFI) in a absolutely safe way, usually you need a distiller; USP admits also RO systems, such as “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). To discover how to get WFI in this website: Methods to produce Water for Injection

DEC 2019, Bram-Cor main factory, Parma (Italy). Set of seven STMC distiller in construction. They will be delivered in the course of 2020
Bram-Cor main factory, Parma (Italy). Set of seven STMC distillers in construction. Today they are at the forefront of vaccine production.

Water for Injection equipment manufacturing

If you 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 machinery. 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.

 

Videos from BRAM-COR Youtube Channel

In an intensive day of contacts and presentations, Francesco Vasé presented the cornerstones of the Bram-Cor offer for the pharmaceutical industry, the company's core business.
CPHI BARCELONA 2023 Interview with Bram-Cor sales director Francesco Vasé
Bram-Cor integrates its PW-WFI-PS Generation equipment with state-of-the-art distribution loops. The Loop design is the result of a careful evaluation of Points of Use delivery criteria such as: - Maximum istantaneous flow rate - Pressure & temperature requirements - Sanitization issues - Periodic consumption requirements and duration - Method of delivery (automatic or manual) The loop construction and installation is carried out by qualified welders following Bram-Cor sanitary piping procedures, according to ASME BPE standards.
Bram-Cor Distribution Systems - Points of Use (POUs)
BRAM-COR PHARMACEUTICAL TECHNOLOGIES Water Treatment Systems + Processing systems + Filling Systems producing PW / WFI and IV Fluids / Parenteral solutions. Thanks to a fruitful experience in many branches of making pharmaceuticals, BRAM-COR has matured a coherent path, able to face meaningful business opportunities for customers who wish to diversify or set up production lines of parenteral solutions, both for bags and for bottles, within turnkey or segmented projects. In this video, we can see a complete line producing LVP (Large Volume Parenterals).
Bram Cor Water treatment + processing systems producing IV Fluids
From a 3D view, a formulation vessel for pharmaceutical purposes, such as parenteral solutions and Intravenous fluids. Bram-Cor offers a complete range of preparation lines suitable for any pharmaceutical formulation: - BIOREACTORS (reactor vessels, pressure vessels) - MIXING TANKS (pressure tanks, mobile mixing vessels) - CUSTOMIZED FORMULATION TANKS (for high purity water mixing with powders) - ATMOSPHERIC TRANSFER TANKS The accurate finishing and the high quality of the materials used in the construction of all our equipment ensure aseptic drug manufacturing, in accordance with international cGMP and pharmacopoeias.
Bram-Cor DISS Formulation systems - Pharmaceutical Processing
DISTILLATION. THE MAIN WAY TO PRODUCE WATER FOR INJECTION. These frames from Bram-Cor, Italy, show the process steps of a vapor compression distiller, producing WFI (Water For Injection) for pharmaceutical purposes. BRAM-COR STMC Vapor Compression Distiller (VCD) produces compendial water for pharmaceutical applications and parenteral preparations, such as LVP, SVP, any injectable product, washing medias and special solutions where both quality factors (such as the sterility, elimination of the pyrogens and of the chlorine solvents with low molecular weight) and economical factors, (low running costs) are critical for the success of the pharmaceutical process. Each STMC can produce both cold Distillate or hot Distillate with huge savings of energy costs and with no need of cooling water. BRAM-COR vapor compression distillers operate with electrical heating or plant steam heating or even through both electrical and steam heating systems. Capacities range: from 20 to 20.000 lph with one/more blowers. The recognized benefits of the BRAM-COR Vapor Compression Distillation technology are : • Low energy consumption • No need of cooling water to condensate the pure steam • No need for high quality inlet water (in some cases even softened water can feed the VC still) • Very high quality of the WFI thanks to the strong degassying process • No need to pressurize the inlet water • WFI outflow at high pressure (1–1.5 bar) without any additional pump • Extreme safe process, with no risk of any cross contamination through plant steam or inlet water • Highest flexibility in terms of capacities and WFI temperatures • Reduced Maintenance
Water for Injection systems - How Vapor Compression distiller works
Bram-Cor turnkey line, with water pretreatment, producing PW via Reverse Osmosis system, and Water for Injection (WFI) via Vapor Compression Distillation system. Downstream of the plant you can see loop, storage and user point for WFI.There are also separate loop, storage and user point for Purified Water (PW).
Water for Injection systems - Bram-Cor Turnkey Line producing WFI via Vapor Compression Distillation
Bram-Cor pharmaceutical turnkey line for sanitization, with water pretreatment, PW via Reverse Osmosis, storage, loop, Pure Steam Generation system. In this line, downstream, you can see a Bram-Cor DISS mobile preparation/formulation systems (dissolutor/mixer) located in the first clean rooms (autoclave is present in the second clean room).
Sanitization of pharma processing systems - Bram-Cor turnkey plant with Pure/Clean Steam Generator
PURIFIED WATER SYSTEMS AND "COLD" WFI PRODUCTION FOR PHARMACEUTICAL MANUFACTURING BRAM-COR ensures a clear answer to any request related to water treatments for pharmaceutical water production and any other critical water application (e.g. cosmetics, health-care, human and animal aliments). We apply a very focalised and precise approach and a wide range of specific knowledge. Our reverse osmosis CROS systems, are designed to produce purified water (PW) and water for injection (WFI), through a number of water treatment phases, based on specific feed water’s quality and on the specified production’s necessities. Specifically, Mod plants. CROS with reverse osmosis technology for pharmaceutical use (Sanitary Reverse Osmosis Systems) produce PW in a highly convenient and efficient manner and, with downhill systems, an additional ultrafiltration and for WFI. CROS operates through different water treatment phases, both related to the specific water quality and to the production necessities. The treatment phases include: - Sodium hypochloride dosing station for water disinfection and oxidation of organic substances, reducing the bacterial charge - Sodium metabisulphite dosing station for neutralization and chlorine - Double filtration system to eliminate solid substances in inlet water - Single or double osmotic stage - Continous Electro-Deionizer - UV lamps - Final sterile filtration -0,22 µm While WFI needs downhill ultrafiltration, purified water, traditionally produced through reversed osmosis, is commonly produced through: Single stage RO + Electrodeionization Double stage RO Double stage RO + Electrodeionization
Purified Water production. Bram-Cor CROS Reverse Osmosis Systems. 3D view.
WATER FOR INJECTION PRODUCTION FOR PHARMACEUTICAL MANUFACTURING BRAM-COR SMPT Multiple Effect Distillers are designed and manufactured according to cGMP to produce compendial Water for Injection (WFI). Each unit contains a number of boiling columns (or effects) with the first column producing pure steam, which is condensed and re-distilled in the following columns, decreasing the operational costs. Heating for evaporation and cooling for condensation processes are performed by double tube sheet (DTS) exchangers. The higher the quantity of columns the lower overall the consumption of the equipment. A special labyrinth-separator installed at the top of each column separates the steam generated by the evaporation process from entrained substance in the steam itself. The result is a pure, “dry”, pyrogen-free steam, condensed in compendial Water for Injection. The first column of the Still may be used to produce alternatively or even at same time, also Clean Steam. Pressure vessels are designed according to ASME and PED regulation and the equipment features: - Double tube sheet heath exchangers - Certified AISI 316L stainless steel mirror-polished and passivated product contact surfaces - AISI 304 frame, jackets and control board - PTFE gaskets - Pneumatic valves with Teflon membranes and AISI 316 L SS polished body - ASTM C-795 – compliant insulation. Capacities range: from 50 to 15.000 lph with three to ten columns.
Water for Injection systems. Bram-Cor SMPT Multi Effect Distiller. 3D view.
Carica altro... Subscribe

BRAM-COR Catalogue PDF viewer

Catalogue. Click on the image to see “at a glance” Bram-Cor equipment for pharmaceutical manufacturing.

 

How the equipment produces WFI

First of all, to discover how Vapor Compression Still (VCD) works: Vapor compression distillation process

Similarly, to discover how Multi Effect Distiller (MED) works: Multiple effect distillation process

Furthermore, to discover how reverse Osmosis + Ultrafiltration (RO+UF) works: Reverse Osmosis + Ultrafiltration system 

Site sponsored by BRAM-COR Italy | waterforinjection.com Cookie Policy

USEFUL LINKS

bram-cor.com – main site

 

To view Bram-Cor Equipment catalogue

Where Bram-Cor Equipment works

 

About pharmaceutical water treatment systems:

multiple-effect-water-distiller.com

vapor-compression-distiller.com

pharmaceutical-reverse-osmosis-systems.com

pure-steam-generator.com

 

About pharmaceutical process systems and turnkey plants:

bram-cor-pharmaprocessing.com

ivfluids-parenteralsolutions.com

pharmaceutical-turnkey.com

Bram-Cor You Tube Channel

SUBSCRIBE

Keep in touch with BRAM-COR SPA

* indicates required

Among the many possible forms of contact, we only ask you to allow the sending of emails from our offices, checking this option:

You can unsubscribe at any time by clicking the link in the footer of our emails. For information about our privacy practices, please visit our website.

We use Mailchimp as our marketing platform. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. Learn more about Mailchimp's privacy practices here.

Copyright © 2024 · All Rights Reserved · Water for Injection Systems

Nonprofit Website by GivingPress · RSS Feed · Accedi