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Pure Steam Generator
INJECTABLE ITEMS
Description
Pure Steam Generators are used for the sterilization of certain items, such as fermenters and filters, whenever any item comes into direct contact with a sterile medicinal product. They are utilized in various articles within the pharmaceutical industry. The Pure Steam Generator Plant is available in different configurations and comes with a wide range of instrumentation for fully automated operation. It is designed and fabricated according to the ASME Section VII Division 1 and TEMA fabrication codes.
- Standard Model Capacity: 50 to 3000 liters/hr
- Application: To produce pyrogen-free sterile steam that conforms to IP/BP/USP standards for sterilizing process vessels, pipelines, and autoclaves, and to maintain the humidity of the manufacturing area.
- Optional Accessories: NCGR Column; SCADA with IPC
Features
- Electro-polished SS316L tubes provide a smoother surface for complete water drainage and reduce erosion-corrosion.
- Double tube sheet construction for the main evaporator and pre-heater column prevents cross-contamination.
- All pipe joints are orbital welded.
- Food-grade PTFE ‘O’ rings are used, compliant with USP Class VI.
- Low maintenance cost.
- High-pressure centrifugal pump for feed water.
- Online monitoring of feed water and WFI conductivity.
- Fully automated PLC-based system with four levels of password protection and basic 21 CFR compliance, including online printing.
- Auto-drainage system for the first column.
- Complete steam station for raw steam, featuring a PID pneumatic globe valve.
- Cartridge-type filter housing for feed water.
Technical Specifications
SYSTEM REQUIREMENT
Feed Water:
- Purified water as per USP29 with a max conductivity of 1 micro-ohm.
- Pressure should be 1kg/cm2 higher than the raw steam pressure.
- Temperature Ambient 30OOC.
Feed Steam:
- Steam must be saturated, dry, and free from oil, vapors & other impurities. (A steam filter to obtain 3B, clear quality steam).
- Steam pressure min 6kg/cm2 is essential to guarantee pyrogen-free distillate.