Each BRAM-COR CROS system is a highly customized equipment, designed starting from local feedwater analysis and from customer’s production requirements, in order to ensure the quality attributes for PW defined by the international pharmacopoeias and by customer’s URS.

Coupled with polishing Ultrafiltration, this membrane process technology is used to produce cold WFI, as an alternative to distillation for the pharmaceutical industry, or Ultrapure Water for other industrial fields, such as semiconductors.

In association with GMP storage and distribution systems, designed to prevent biofilm growth ensuring continuous disinfection, WFI generators based on non-distillation technology are suitable for pharmaceutical production processes using cold WFI without expensive thermal treatment.

• Production of Purified Water (PW) and/or Water for Injection (WFI) for pharmaceutical/cosmetic use and laboratories.

• Production of Ultrapure Water for microelectronics and other industrial fields.

• Designed, automated and validated according to GAMP 5, fully compliant with the latest specifications of latest ASME BPE, international GMP, USP and Ph. Eur.
• In-line measurement of process parameters (such as conductivity, temperature, pH)
• Water recirculation during idle periods to prevent biofilm growth
• Centrifugal booster pump in SS with electronic pressure transducers automatically regulating pump capacity
• All surfaces in contact with PW are in certified AISI 316L stainless steel and in compatible materials according to applications
• Equipment skids and control cabinets in AISI 304 stainless steel
• Orbital and manual welds executed by qualified welders
• Full traceability of all components
• Sampling points after each treatment step
• Comprehensive and standardized Commissioning & qualification package (FAT, IQ, OQ)
• Reduction of microbial contamination through regular hot water sanitization
• Possibility to produce WFI through Ultrafiltration unit (UF)
• Can be combined with customized feed water pretreatment systems and with PW or cold WFI storage and distribution 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

  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 and 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).

• CROS Reverse Osmotic equipment is endowed with a Recycling system of the concentrate in order to obtain a higher recovery with a lower consumption of inlet water.

• Features include:
  • Centrifugal booster pump in compliant materials, electronic pressure transducers automatically regulating the pump capacity;
  • AISI 316L Stainless steel membrane vessels;
  • Sanitary in-line instrumentation to monitor product critical parameters, such as conductivity, pressure, flow, temperature, pH.

• CROS customizable configurations, are:
  • Single stage RO + Electrodeionization
  • Single stage RO + Electrodeionization + Ultrafiltration
  • Double stage RO – Double stage RO + Electrodeionization
  • Double stage RO + Electrodeionization + Ultrafiltration

• The Reverse Osmosis unit can also use the latest hot water sanitizable advanced membrane technology to remove up to 99% of dissolved inorganics and organics, colloids and particles.
• CROS is available either in single or twin pass Reverse Osmosis, with additional permeate refining and disinfection systems, such as EDI module, gas stripping station, UV reactor, and Ultrafiltration module, according to the URS.