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. BRAM-COR Vapor compression still can work with any feed water; furthermore, customized models with pretreatment systems integrated on the same skid (STMC AEL/AST, electrical/steam heating with automatic water softeners; REL/RST, electrical/steam heating with water pretreatment + reverse osmosis system) allow STMC distillers to virtually work with any water available on site.
Pharmaceutical Vapor Compression Distillation (VCD), improperly known as thermocompression or such as mechanical vapor recompression (MVR) or mechanical vapor compression (MVC), too, is the main way to produce grade waters for pharmaceutical production environment. Therefore, BRAM-COR STMC Vapor Compression Distiller (VCD) produces compendial distilled water (WFI, Water For Injection) 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.
BRAM-COR STMC "thermocompression" still can produce both cold Distillate or hot Distillate with huge savings of energy costs and with no need of cooling water. STMC 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 degassing 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
The design, construction and documentation of BRAM-COR STMC distiller strictly complies with GMP and FDA regulations, ensuring an easy certification by the relevant authorities. In detail:
•The Distiller is made in certified AISI 316L stainless steel
•All internal parts in contact with the infeed water, the Pure Steam and the Distillate, are mirror-polished
•All hydraulic connections are sanitary tri-clamp or flange connection
•All gaskets are made in PTFE
•All weldings are T.I.G
•Vapor is compressed by a special blower.
A full automation (Siemens®, Rockwell®, SCADA system) ensures easy operation and total monitoring of critical parameters, by means of certified in-line instruments and of a careful alarm policy. Access policy and records can be managed according to 21 CFR PART 11.
See also our website vapor-compression-distiller.com