BRAM-COR Pharmaceutical Water Treatment Systems are designed to produce;
- Purified Water
- Water for injection (WFI)
- Clean Pure Steam Generation
Pre-treatment options, monitoring of critical parameters, regulatory requirement for product quality, consumptions, microbiological control, operation and maintenance requirements, lifecycle costs are taken into considerations in the design of all processing steps, from feed water to the point of use.
Special care is given to the choice of sanitary materials. Product-contact surfaces are in certified AISI 316L stainless steel, with standard roughness ≤ 0.4 µm. PTFE gaskets ensure perfect sealing. Advanced Process Analytical Technologies are applied for monitoring issues and professional GAMP compliant automation is provided for system control.
Purified Water Generation
Purified water is usually obtained through single stage RO + Electrodeionization, double stage RO and double stage RO + EDI. In each RO stage, water is processed through thin film composite RO membranes, offering the highest rejection of contaminants. Two different flows are generated by the RO system: permeate water, corresponding to PW specification, and RO concentrate, which is recycled in the system in order to obtain a higher recovery with a lower consumption of inlet water. CROS equipments, with a range of capacity spanning from 100 up to 20,000 lph, are manufactured according to all cGMP and FDA rules, including:
- Centrifugal booster pump in AISI 316L stainless steel, completely mirror polished both internally and externally
- AISI 316L stainless steel membrane vessels
- Sanitary in-line instrumentation to monitor product critical parameters, such as conductivity and temperature
- Full automation managed through GAMP-compliant hardware and software
- Framework and control board in AISI 304 stainless steel satin finished
- CIP sanitization or HOT WATER sanitization.
Water for injection (WFI) from Multiple Distillation
Heating for evaporation and cooling for condensation processes are performed by double tube sheet heat and cool exchangers. Condensation is achieved by means of the thin-falling film system. The process is repeated in each column; the higher the number, the lower 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. Pressure vessels are designed according to PED regulation, and the equipment features:
- Double tube sheet heat 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 PTFE membranes and AISI 316 L SS electro-polished body
- ASTM C-795-compliant insulation
Clean Pure Steam Generation (CPSG)
cGMP and PED standards are baseline criteria in our CPSG Pure Steam Generators design and construction: material and instruments are certificated and all welds are made by qualified welders.
- The evaporation column is designed to minimise steam speed to avoid the entrainment of water droplets, which are separated from the steam by means of a special separator.
- A Double Tube Sheet Heat Exchanger provides heating of pre-treated feed water above the boiling temperature, generating Pure Steam which expands into the evaporation column. Heating medium in the DTS Heath Exchanger is typically industrial steam at 100 to 120 psig (7.9 to 2.0 bars).
- Pure Steam pressure is maintained by an electronic control system, modulating the supply steam control valve and monitoring the evaporator feed water. The system shall be fed with Purified Water.
KPSG Kettle Pure Steam Generators provided with a horizontal evaporation chamber with kettle end, are also available for special space needs.
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