WATER FOR INJECTION SYSTEMS

proud to be AT the heart of the pharmaceutical manufacturing system

Water is an intrinsic component of all pharmaceutical formulations; without water there can be no preparations to make vaccines, IV Fluids, parenteral solutions, ointments, eye drops, antibiotics, creams and all drugs that require a solvent compatible with human nature. This BRAM-COR site clarifies some aspects related to the use of Water for Injection and other pharmaceutical grade waters, especially for the production of I.V. fluids and parenteral solutions. 

Water for Injection definition

What is the meaning of “Water for Injection” 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? When a water meets the pharmacopoeias requirements of a pharmacopoeia is called a compendial water. Although the correct water treatment system is the basis for the final quality of any pharmaceutical solution, there are factual differences in evaluation of the technologies used to produce each compendial water. All these technologies are part of our core business, so these pages offer a concrete knowledge of the leading considerations in pharmaceutical field. Our hope is that this site will be useful not only to our customers, but also to the many students who ask 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

You can also read a “Guideline on the quality of water for pharmaceutical use” from EMA (European Medicines Agency) (Site source: https://www.ema.europa.eu/en/homepage)

Bram-Cor water Treatment Room

Water for Injection distillers

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 also allows 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

On the side: Bram-Cor main factory, Parma (Italy). Set of seven STMC distillers in construction. Today they are at the forefront of vaccine production.

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 TECHNOLOGIES FOR WFI AND PW FORMULATIONS, INTRAVENOUS AND PARENTERAL SOLUTIONS

Water for Injection equipment manufacturing

WFI equipment is made in compliance with International Good Manufacturing Practices (cGMP), which are common to all BRAM-COR machines. It must also be remembered that all the different Pharmacopoeias in the world are the basis form BRAM-COR’s work. So we have an infinite number of customizations. Visit our main web site (bram-cor.com) to discover BRAM-COR’s expertise in many types of pharmaceutical equipment, from water treatment to processing and filling.

We are also proud to say that our equipment is entirely manufactured and customized in Italy. In fact, BRAM-COR experience and passion for working with stainless steel, allow usmto care for quality in every details. In addition, energy saving, sanitary quality and certifications, long-term reliability are the rule for BRAM-COR distillers and water treatment systems.

How the equipment produces WFI

BRAM-COR Catalogue PDF viewer

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

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.
PURE STEAM GENERATION FOR PHARMACEUTICAL AND INDUSTRIAL MANUFACTURING BRAM-COR Pure Steam Generators Mod. CPSG produce dry, saturated steam, suitable for sterilization of pharmaceutical production plants, for direct contact with Active Pharmaceutical Ingredients, for Parenteral and Non-Parenteral dosage form applications. The steam, when condensed, meets USP requirements for Water-for-Injection. The steam is purified using centrifugal and gravity separation methods. In detail: - The evaporation column is designed to minimize steam speed to avoid the entrainment of water droplets, which are separated from the steam by means of a special separator. - A Double Tube Sheet Heat Exchanger provides heating of pre-treated feed water above the boiling temperature, generating pure steam which expands into the evaporation column. Heating medium in the DTS Heat Exchanger is typically industrial steam at 100 to 120 psig (6 to 8 barg). - Pure steam pressure is maintained by an electronic control system, modulating the supply steam control valve and monitoring the evaporator feed water. The system shall be fed with Purified Water and heated and heated using industrial steam, however heating can also be achieved using superheated water or with direct electrical power supply. Capacities range: from 20 to 8000 kg/h.
Bram-Cor CPSG - Pure Steam Generator - 3D view.
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