BRAM-COR VAPOR COMPRESSION DISTILLERS CAN VIRTUALLY WORK WITH ANY WATER!
SAFE PRODUCTION OF WATER FOR INJECTION ACCORDING TO GMP AND FDA RULES
Water For Injection can be produced through distillation or through a downstream unit of ultrafiltration in a Reverse Osmosis system. The more safe methods are the distillation processes. Vapor compression distillation is a formidable distillation system because it uses a very profitable technology: the mechanical compression of the vapor generated by the machine, which involve a quick change of state.
Not only that, but it is also necessary to consider the design and construction quality of the entire distillation system, suitable for use in the pharmaceutical industry. BRAM-COR project drivers are aimed at satisfying all pharmaceutical regulatory and QA requirements, aligning the Vapor Compression Distiller manufacturing to the international cGMP (Good Manufacturing Practices) and Pharmacopoeias.
Furthermore, there are customized models with pretreatment systems integrated on the same skid: STMC AEL/AST, with automatic water softeners, and REL/RST, with water pretreatment + reverse osmosis system. For this reason, BRAM-COR STMC vapor recompression still can virtually work with any water available on site.
FULLY AUTOMATIC CONTROL SYSTEMS
BRAM-COR target in STMC design, manufacturing, documentation, testing and validation activities focuses on the overall compliance of equipment to the needs of the pharmaceutical and biotechnology industry. Highly customized, STMC models have fully automatic control systems (Siemens® or Rockwell® automation unit; touch screen SCADA for compliance to 21 CFR PART 11).
STMC Vapor Compression Distillers ( see here BRAM-COR Water Treatment Systems) produce WFI (Water For Injection) according to USP, EP and FDA rules. The distillate is free from Oxygen, Carbon Dioxide, Chlorine solvents, Salts, Heavy Metal, which are eliminated by the two special degassing systems. Example: considering an infeed water with a conductivity not higher than 1 microSiemens, the STMC distiller can produce a distillate at 25/30°C at a conductivity of 0,08 microSiemens/cm and a pH of 6,9÷7.
VAPOR COMPRESSION DISTILLATION KEY FACTOR: INTERNAL PRESSURE HIGHER THAN ATMOSPHERIC
STMC Vapor Compression Distillers always work at an internal pressure higher than atmospheric, preventing outside air from entering the plant. In every distillation phase, the distillate is always at a pressure higher than the feed water thereby ensuring that in the likelihood of leakage, the feed water will never enter the distillate circuit.
BRAM-COR STMC CAN WORK WITH ELECTRICAL AND/OR STEAM HEATING
BRAM-COR Pharmaceutical Vapor Compression distillers STMC can produce both cold Distillate or hot Distillate with huge savings of energy costs and with no need of cooling water. It can work:
- with electric heating (STMC EL, AEL, REL )
- with steam heating (3 bar) exclusively (STMC ST, AST, RST)
- or both with electrical and steam heating (STMC ES). This type of heating is useful when the distiller works 24 hours/day usually, and when there is a lack of industrial steam overnight.
WITH BRAM-COR VAPOR COMPRESSION DISTILLER A LOT OF SECURE BENEFITS
There are a lot of secure benefits in the use of BRAM-COR Vapor Compression distillation system.:
- 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.
See this page for specific knowledge.
EXPERIENCE & EXCELLENCE, FROM DESIGN TO AFTER SALES SERVICES
BRAM-COR is a leading company in customized pharmaceutical technologies and in biopharmaceutical turnkey plants, with a long term experience, dating back to 1964.
So, a proper high level of professional services integrates the STMC Distillers top quality, including:
- Technical Documentation
- Factory Acceptance Test
- Commissioning, Site Acceptance Test & Start-up
- After Sales Service
BRAM-COR worldwide network of skilled agents and our affiliated companies ensure assistance to our Clients in over 50 countries, from the very beginning of a pharmaceutical project throughout decades after start-up. Moreover, BRAM-COR After Sales Department grants punctual and quick deliveries of spares and ongoing technical support.
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