Design Qualification of Ointment Manufacturing Vessel

• Design Qualification of Ointment Manufacturing VesselOBJECTIVE
• To design, engineer, and supply the Ointment Manufacturing Vessel and to provide assurance that the machine is manufactured and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same at utmost transparency.

• SCOPE
• The scope of this qualification document is limited to the Design Qualification of Ointment Manufacturing Vessel. This qualification document is part of a validation activity for the Ointment Manufacturing Vessel

• RESPONSIBILITIES
  • CLIENT
    • To Check and Approve the design qualification.
  • MANUFACTURER
    • To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
      • Machine overview,
      • General arrangement drawing,
      • Equipment orientation with layout,
      • Specifications of the sub-components/ bought out items, and their make, model & quantity, and backup records/ brochures,
      • Details of Utilities,
      • Identification of components for calibration
      • Material of construction of all components
      • Safety features and alarms

• Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT document.
• To confirm the safe delivery of the equipment to the user site.
• To ensure that no un-authorized and or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.
• To ensure the proper installation and commissioning of the equipment.

• MACHINE DESCRIPTION
• Main Manufacturing Vessel
• Main vessel facilitates the Mixing and emulsification of both wax and water phases to form ointment. This is a jacketed cylindrical vessel and works under vacuum. The S.S. jacket is provided for hot water heating. The hot water enters from the water inlet and the condensates leaves through the bottom outlet provide to the jacket. The jacket is insulted with 50 mm thick Rock Wool Material to prevent the heat loss.
• At time of cooling the cooling water enters from bottom of jacket for cooling purpose.
• The torrospherical top dish is bolted to the vessel and vessel and is provided with white silicon gasket fitted in its groove to make the vessel air tight. Mounted on the top dish are manhole, light glass and sight glass. The inlet for oil inlet and water inlet are also welded to the product shell.
• The vessel is provide with specially designed anchor type agitator , driven by a 3 HP, 3 phase, 415 volts,1440 RPM STD TEFC electric motor. The drive is transmitted through the 5” CRS, Ration 50:1 reduction gearbox to achieve approx. 14 – 28 rpm of agitator. The driving shaft is provided with stuffing box in order to prevent leakage of air inside the vacuumised vessel. The floating type Teflon scrapers bolted of the anchor prevent the accumulation of material on the inner walls of vessel.
• The built in high speed emulsifier is mounted sideways on the main vessel at predesigned angle. The emulsifier is directly coupled to the extending SS 316 shaft of 10 Hp, 1440 PRM STD TEFC motor. The high speed emulsifier plays very critical role of making a Homogeneous Wax- water emulsion thus forming the ointment. Specially designed mechanical seal is provided to homogenizer casing to prevent leakage.
• The vessel is provided with the Flush Bottom full flush Bore – Valve of 2” to facilitate the Ointment Discharge. The Discharge is connected to Transfer Pump, which transfers the finished product to the storage Vessel. The PT – 100 temperature sensor helps in monitoring the Temperature inside the vessel.
• Interconnecting Piping
• The SS 316 piping is duly Elector-polished from inside and dull polished from outside.
• All the joints are TC types. The piping can broadly be classified as follows:

• From Wax phase vessel to ointment manufacturing vessel.
• From to ointment manufacturing vessel to Transfer Pump.
• Control panel
• The control panel is totally fabricated out of stainless steel SS 304 14 SWG. The panel houses all the necessary controls, safeties, indicators, contactors and switches. Supply voltage 415 V, 50 Hz, 0 Neutral, 1 Earthing.
• Working Platform
• SS 304 dimple plated platform with SS railing and stair case is provided for the proper operation and controlling of plant.

• TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS

• DETAILS OF UTILITIES
  • Power Consumption
  • Stabilized electrical supply 17 HP Load; 415 V, 50 Hz Freq. with proper earthing to be connected to the control panel.

•  MATERIAL OF CONSTRUCTION

•  Critical Instrument for calibration
  • Temperature Sensor (Jacketed Vessel)
  • Temperature Sensor (Main Vessel)
  • indicator cum controller (Main Vessel)
  • indicator cum controller (Storage Vessel)
  • Pressure Gauge (Jacketed Vessel)
  • Pressure Gauge (Main Vessel)
• ENCLOSURES

• FAT PROCEDURE
• Factory Acceptance Test Procedure shall be as follows:
• After the completion of erection work of the machine, client shall be informed to perform the factory acceptance test (FAT).
• Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT document as per the details given below:

• Test criteria
• Design Verification Check list
• Deficiency & Corrective Action report
• Pre-installation requirements
• Final report

• CHANGE CONTROL PROCEDURE
• Change in the agreed design shall be addressed through the well-defined Change control procedure.

• DESIGN QUALIFICATION REPORT

• LIST OF ABBREVIATIONS

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