WFI BY PURE STEAM GENERATOR (PSG)
PHARMACEUTICAL PURE STEAM & INDUSTRIAL CLEAN STEAM
Pure Steam (PS), often referred to as Clean Steam (CS) in industry, is the right way to solve the problem of sterilization of plants and equipment, not only in WFI manufacturing, but virtually in every critical point of any process line (biopharma, food, beverage, cosmetics and so on).
Pharmaceutical Pure Steam Generator Mod. CPSG produces dry, saturated steam, suitable for sterilization of pharmaceutical production plants, for direct contact with Active Pharmaceutical Ingredients, for Parenteral and Non-Parenteral dosage form applications. The steam, when condensed, meets USP requirements for Water for Injection (WFI). The steam is purified using centrifugal and gravity separation methods.
Two coupled Bram-Cor CPSG Pure Steam Generators in a water treatment room
cGMP and PED standards are baseline criteria in Bram-Cor CPSG design and construction: material and instruments are certificated and all welds are made by qualified welders. In detail:
- The evaporation column is designed to minimize 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. The heating medium in the DTS Heat Exchanger is typically industrial steam at 100 to 120 psig (6 to 8 barg).
- 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 and heated basically through Plant Steam but also by Electricity or even Superheated Water. Capacities range: from 20 to 5000 kg/h.
| PURE STEAM - quality critical attributes | ||
| PHISICAL / CHEMICAL | Ph. Eur. | USP |
| Conductivity | Not defined | ≤ 1.3 μS/cm @25°C |
| TOC | Not defined | ≤ 0.50 mg/L |
| MICROBIOLOGICAL | Ph. Eur. | USP |
| Bacterial count | ≤ 10 CFU/100 ml | ≤ 10 CFU/100 ml |
| Bacterial endotoxins | < 0.25 IU/ml | < 0.25 EU/ml |
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