WATER FOR INJECTION FROM MULTI EFFECT DISTILLATION
BRAM-COR offers a wide range of Multiple Effect Distillation systems. SMPT, our Multiple Effect Distiller, is designed and manufactured according to cGMP to produce compendial Water for Injection. 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.
Each component is identified by a unique TAG, engraved on metal plate, for total traceability in the relevant technical documentation. Functional testing is ensured by automation experts, with special care for monitoring of critical parameters. Documentation, inspection and field testing are included in our project management. Capacities range: from 50 to 15,000 kg/h.
BRAM-COR SMPT – TECHNICAL REFERENCES
| Destination of use | Production of Water for Injection for pharmaceutical use. The SMPT distillers (from 3 to 10 columns) produce sterile and free from pyrogen water, in accordance with cGMP and FDA regulations. |
| Technology | Each unit contains boiling columns (or effects) with the first column producing pure steam, which is condensed in the following column decreasing the operational costs,or used as PS. The higher the quantity of columns, the lower overall the consumption of the equipment. The quantity of columns therefore does not influence the quality nor the output of the equipment. |
| Technical features | • cGMP design and construction, made in Italy |
| • All product contact surfaces in AISI 316 L stainless steel | |
| • Jackets, frame and control board in AISI 304 stainless steel | |
| • All welds are executed by qualified welders | |
| • Gaskets in EPDM or PTFE or Silicone | |
| • Pneumatic valves with Teflon/PTFE membranes and AISI 316 L SS polished body | |
| • ASTM C-795 – compliant insulation | |
| • Instruments: conductivity meter, pressure transducers, temperature probes, level transmitter, flow meter | |
| • Adjustable feet | |
| • Self-sanitizable | |
| • Available pure steam production from the first column | |
| • Available in steam operated or electrically operated model | |
| Control system | Functions operated by the PLC (Programmable Logic Controller): • Input of measured values and setting of limit values • Automatic Sequences (production, sanitization, …) • Control Functions (PID control for valves and speed of pump) • Alarm management and Verification of parameters • Input of measured values and setting of limit values • Output commands for digital and analogic values |
| Visualization system | HMI (Human Machine Interface): • Display of machine state • Controls management • Verification of alarms • Set points inserting and limit values setting • Graphic interface SCADA (Supervisory Control And Data Acquisition) / SCADA SERVER • All HMI values and controls • Data historicization • Historical alarms• Trend • Report • Recipes formulation / Batch • Data backup / Restore All automation systems can be in compliance to 21 CFR PART 11 or Siemens Operator Panel, through audit management and electronic signature. Access management included (user/password). |
| Communication system | Bram-Cor automation systems can virtually communicate with all network partners through maximum security protocol (Ethernet, Profinet, OPC Unified Architecture, …) Options: • Teleservice (malfunctions managed remotely by Bram-Cor) • Remote Control (customer operator receives a message / a text message / a warning mail) • Server-side data centralization (customer can centralize data on his service, or Bram-Cor provides it) |
| Sterilization | Sterilization can be performed as one-shot selection before production start or as a single phase, to be periodically performed on the WFI system. |
