ASME BPE Pharmaceutical Pure Steam Generator cGMP/USP/EP/FDA/WHO/PIC/S

详情

APPLICATION:

KSG pure steam generator is designed to meet cGMP requirements and is used to produce high-quality pure steam. Its pure steam quality meets the requirements of China, Europe and the United Sates Pharmacopoeia. Adopt falling film type evaporator and a unique separation technology for producing pyrogen-free pure steam. This design approach has been proven reliable in over ***0 validated installations. In addition, Kaisen also owns a number of patents related to Pure Steam Generator and carries out continuous innovation, so as to provide customers with first-class equipment which is always in the leading position in the industry.

MAIN FEATURES:

• Unique three-stage separation technology
• Separation of non-condensable gases from feed water is a standard feature designed to reduce the content of non-condensable gases from a maximum of 6 % to less than 3.5 %
• With the concept of risk prevention design
• Provides fast, smooth, continuous operation and avoids repeated cycling (starting and stopping) of the unit, which conserves utilities and provides a consistent pure steam pressure.
• Double tube sheet expansion design
• Automatic control and adjustment of the plant steam and feed water that correspond to the selected user configurable pure steam pressure
• Pure steam pressure variations do not typically exceed ±5% from the user configured set point in static conditions; Stabilizing time after pure steam demand variations is approximately *0 seconds
• Due to the Kaisen design a pure steam pressure reducing valve is not required
• Fast response during varying pure steam demand
• Carry out production and quality control in accordance with V-Model, and form a complete document system that meets the requirements of US FDA, EU GMP, and WHO GMP
• The High standard pure steam specification (non-temperature compensated conductivity 0.**0.5μs/cm at *5℃, endotoxin <0.*1EU/ml)