SISTEMI PER PRODURRE ACQUA PER INIETTABILI

ORGOGLIOSI DI ESSERE AL CENTRO DEL SISTEMA PRODUTTIVO FARMACEUTICO

L'acqua è un componente intrinseco di tutte le formulazioni farmaceutiche; senza di essa non potrebbero esistere preparazioni fondametali per la realizzazione di vaccini, fluidi per flebo, soluzioni parenterali, unguenti, colliri, antibiotici, creme ed ogni altro farmaco che richieda un solvente compatibile con la natura umana. Questo sito BRAM-COR chiarisce alcuni aspetti relativi all'utilizzo di acqua per iniettabili e di altre tipologie di acque farmaceutiche, con particolare attenzione alla produzione di fluidi per flebo e soluzioni parenterali.

Definizione di acqua per iniettabili
(aqua ad iniectabilia)

Qual è il significato di “Acqua per Iniettabili” in Europa piuttosto che in Giappone o negli Stati Uniti? Qual è la tecnologia migliore tra la distillazione a vapore compresso e quella a multiplo effetto? I sistemi di osmosi inversa possono produrre WFI a freddo in modo sicuro? Ci sono differenze tra WFI sterile e WFI batteriostatica? Quali sono i valori richiesti per osmosi inversa, ultrafiltrazione o trattamento UV?

Quando un'acqua soddisfa i requisiti stabiliti da una farmacopea, essa viene definita "compendiale". La scelta del sistema di trattamento dell'acqua è cruciale per garantire la qualità dei prodotti farmaceutici finali. Tuttavia, esistono approcci differenti nella valutazione e nell’applicazione delle tecnologie in uso. Tutte queste tecnologie fanno parte del core business di BRAM-COR, quindi le pagine offrono conoscenze pratiche e specifiche sulle principali considerazioni tecniche e regolatorie richieste nel settore farmaceutico.
Ci auguriamo che questo sito possa essere utile non solo ai nostri clienti, ma anche ai tanti studenti e ai professionisti interessati a comprendere meglio i vari tipi di acqua utilizzati nelle biotecnologie e nelle applicazioni farmaceutiche.
Scopri tutte le acque compendiali in questo sito: WFI e acque compendiali nelle farmacopee

Sala per il trattamento dell'acqua Bram-Cor

Generatori di acqua per iniettabili

L'acqua per iniettabili può essere ottenuta tramite distillazione o utilizzando un'unità di ultrafiltrazione posizionata a valle di un sistema a osmosi inversa. Tuttavia, per produrre acqua per iniettabili (WFI) in modo assolutamente sicuro, di solito è preferibile ricorrere ad un distillatore.
La USP, ciò nonostante, ammette anche i sistemi di osmosi inversa come "un processo di purificazione equivalente o superiore alla distillazione nella rimozione di sostanze chimiche e microrganismi" (come osmosi inversa associata a elettrodeionizzazione, nanofiltrazione e ultrafiltrazione a valle).
Per scoprire come ottenere WFI visita questo sito: Metodi per produrre Acqua per Iniettabili

DICEMBRE 2019, stabilimento principale di Bram-Cor, Parma (Italia). Set di sette distillatori STMC in costruzione. Saranno consegnati nel corso del 2020

Sopra: Stabilimento principale di Bram-Cor, Parma (Italia). Set di sette distillatori STMC in costruzione. Oggi all'avanguardia nella produzione di vaccini.

LE TECNOLOGIE BRAM-COR PER LA PRODUZIONE DI WFI E PW, SOLUZIONI ENDOVENOSE E PARENTERALI

Sistemi di produzione di acqua per iniettabili

sistemi di produzione WFI di BRAM-COR sono progettati e realizzati seguendo rigorosamente le current Good Manufacturing Practices (cGMP), un principio che caratterizza tutte le macchine dell'azienda. Va inoltre ricordato che il lavoro di BRAM-COR si basa sulle prescrizioni di tutte le farmacopee internazionali,offrendo così una gamma praticamente infinita di soluzioni personalizzabili.

Visita il nostro sito ufficiale (bram-cor.com) per scoprire l'ampia esperienza di BRAM-COR nel campo delle attrezzature farmaceutiche, dal trattamento dell'acqua, alla formulazione e al riempimento.

Siamo particolarmente fieri del fatto che tutte le nostre apparecchiature siano interamente progettate e personalizzate in Italia. La profonda competenza e passione di BRAM-COR nella lavorazione dell'acciaio inossidabile ci consentono di garantire un livello superiore di qualità in ogni dettaglio. I nostri distillatori e i sistemi per il trattamento dell'acqua si distinguono inoltre per aspetti fondamentali come il risparmio energetico, la qualità sanitaria certificata e l'affidabilità a lungo termine.

Come i distillatori producono acqua per iniettabili

Catalogo BRAM-COR Visualizzatore PDF

Catalogo. Clicca sull'immagine a lato per vedere "in sintesi" le attrezzature Bram-Cor per la produzione farmaceutica.

Video dal canale YouTube di BRAM-COR

July 8,9 2025 - Amman - JordanGuests of our local partner Pharma Active, we are happy to be present at this important appointment. Arab Pharma is an exclusive pharma exhibition under the umbrella of AUPAM. Why ARAB PHARMA? • An international exhibition on COMPLETE pharma manufacturing • Bringing together the regional buyers and international suppliers • Most effective and interactive forum to participate, explore, resource, connect and network • Strong database of the industry • 192+ exhibiting companies • Exhibition provides the scope to understand the buyers' need • Exhibit and find out the Local Associate to business in Arab nations
Bram Cor with PharmaActive in Amman at ArabPharma 2025
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 MANUFACTURINGBRAM-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 µmWhile 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 MANUFACTURINGBRAM-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.
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