SMART STILL – COMBINATION OF WFI GENERATION PLANT AND PURE STEAM GENERATOR

Product Details :

Pharmalab has been a leading supplier of Water for Injection Plant and Pure Steam Generators for more than three decades. With an aim of providing better solution to its customers, Pharmalab has designed a Smart Still, combination of WFI generation plant and Pure Steam generator,to produce WFI and Pure Steam from a single unit. It is designed to produce WFI & Pure Steam either simultaneously or independently. Smart Still is designed to meet the stringent standards set by major pharmacopoeias like USP, IP, BP, and JP. The still is manufactured as per FDA – current Good Manufacturing Practices (cGMP) and in accordance to ASME requirement. The WFI and Pure Steam is produced on the basic principle of Distillation by Thin Film Evaporation.

This process involves a shell and tube heat exchangers (column) where heat transfer is done by falling film evaporation. High temperature is reached for every drop of water and steam produced, thus ensuring sterility levels demanded for WFI & Pure Steam. Separation of the pyrogenic load is achieved through centrifugal force generated during the upward movement of the steam. Pure Steam generated from this equipment surpasses the steam quality test like non-condensable gases, degree of superheat and saturation test as per HTM 2010 & EN285 requirement. Our plant is designed to be crevice-free as crevices promote stagnation and stimulate bacterial growth. All columns are designed to ASME specifications and are approved by CE for PED regulations as per European Union requirement.

ADVANTAGES :

• Reduces Space Requirement
• Investment cost
• Validation process
• Heat Emission
• Maintenance cost
• Control system
• Manpower

OUTSTANDING FEATURES :

• The plant is completely made in AISI 316L stainless steel with active surface being electropolished.
• Double tube sheet for first heat exchanger where boiler steam is used.
• Unique in-built degasifying (NCGR) system in first column for removal of non-condensable gases from feed water.
• Consistent WFI output temperature.
• Expanded tube for tube-to-tube sheet joints.
• PLC based operation along with all interlocks and validated logic with skid mounted AISI 304 stainless steel control panel.
• Complete documentation to serve international audit requirements.
• Compact design ensures less footprint and shorter column height reduces ceiling height requirement.
• Unique column design requires no additional height for tube bundle removal from top.
• Reduced rouging effect by reduction of pure steam contact surface area within the column.
• Increased life cycle of equipment.
• Ease of maintenance due to reduced working height for pure steam piping and shorter column height.
• The piping system is manufactured with electropolished pipes with Orbital welding, boroscopy sanitary fittings and pharmaceutical grade gasket.
• The insulation is made of rock wool covered by AISI 304 stainless steel sheet.
• The frame is made of AISI 304 stainless steel.

OPTIONAL FEATURES :

• Proportionate Capacity control with full automation
• SCADA communication and 21CFR part 11 compliance
• Drain cooling arrangement to meet environmental norms
• Manufacturing and performance to meet international guidelines like ASME BPE, ‘U’ Stamp and CE for PED regulation
• Self-Sterilization mode
• Stand-by mode
• Preventive maintenance alert through HMI
• VFD based control system to improve efficiency and reduce operating cost
• Cooling water reduction by 80%
• Cooling water recirculation
• Full drainability

Standard designs available with set ratio of WFI to Pure Steam output

Customized designs possible with different ratio of WFI to Pure Steam output as per need