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
DescriptionSpecification
A         Ointment Manufacturing Vessel
1. Ointment Manufacturing Vessel
ModelGMV 400 Liters
Make
Dimension2100 mm (L) X 2100 mm (H) X 1200 mm(W)
Design conditionsJacket: 3 kg/cm2  – working

4.5 kg/cm2  – Test

Shell:   3 kg/cm2  – working

4.5 kg/cm2  – Test

At 600 mmHg of vacuum

FinishInternal–  Mirror

External – Matt

Capacity400 Liters (Gross)

350 Liters (Working )

Cladding14 SWG, AISI 304
ShellCylindrical with flat bottom, 6 mm Thickness, AISI 316 with lift up type lid opening
Baffles2 Nos.
Supporting StructureSS Pipes support mounted on floor
ScrapperTeflon scrapper bolted to anchor
2. Nozzle for jacket
Qty.03 Nos.
Steam inlet and cooling water outlet25 NB
Steam outlet and cooling water inlet25 NB
Jacket vent25 mm (d) with plug
3. Nozzle for vessel
Qty.10 Nos.
Charge hole150 mm (D)
Sight glass100 mm (D)
Vacuum Nozzle25  mm threaded type with vacuum breakers & valves
Discharge50 mm with flush bottom full bore valve on side
Temp. sensor portSensor port for pt – 100 sensor
Charging hopper25 mm flange type nozzle with 10 liters capacity hopper
Oil phase25 mm (D) with valve
Water phase25 mm (D) with valve
Light glass100 mm (D) with light fixture
Recirculation50 mm (D), SS 316 pipe with shaft sealing
4. Agitator
AgitatorAnchor type
MOCSS 316
Dimensions80 mm (L) X 16 mm (T)
Shaft50 mm (D),  SS 316 with Shaft Sealing
5. Motor  (Gelatin Mixing Vessel)
MakeHindustan Motors
Type3 Ph, induction motor, STD TEFC electric motor
Power Rating3 HP / 2.2 KW / 50 Hz / 415 V / 1425 RPM
MakeHindustan Motors
6.Gear Box
MakeGreaves
TypeV 500 ZW
Ratio50:1
7. Motor (Homogenizer)
MakeHindustan Motors
Type3 Ph, induction motor, STD TEFC electric motor
Power Rating10 HP / 7.5 KW / 50 Hz / 415 V / 1440 RPM
8. Filling Pump
MakePositive Metering Pumps
ModelPL3530GMP
TypePlunger / Reciprocating type
Power Rating1 HP
Capacity0 – 600 LPH
9. Filling Pump Motor
MakeHindustan Motors
Type3 Ph, induction motor, STD TEFC electric motor
Power Rating1 HP / 415 V / 1405 RPM
10.Temperature Sensor
MakeNikesh Ind.
ModelPT 100,
Range0-400 0C
11. Temp. Indicator cum controller for main vessel
MakeSelectron
TypeDTC 203
Incoming signalRTD PT – 100, 3 Wire
Voltage230 vAC / 50 Hz
12. RPM Indicator for Anchor
MakeSelectron
TypePIC 101
Power Rating230 VAC / 50 Hz
13.  RPM Indicator for Homogenizer
MakeSelectron
TypePIC 101
Power Rating230 VAC / 50 Hz
14.Timer For Homogenizer
MakeSelectron
TypeXT 56
Power Rating230 VAC
MakeSelectron
15.              Pressure gauge
MakeLA
Range0-10.6 Kg/cm2
Least Count2 Kg/cm2
16. Water Level Controller
MakeMinilec
ModelWLC D1
Supply240 V
17. Variable Frequency Drive (Anchor)
MakeAllen Bradley
ModelPower Flex 4
Power Rating3 HP / 3 PH / 415 VAC
18. Variable Frequency Drive (Homogenizer)
MakeAllen Bradley
ModelPower Flex 40
Power Rating10 HP / 3 PH / 415 VAC
19.Control Panel
RYB phase indicator01 No.
RPm meter for anchor & homogenizer01 No. each
Process timer01 No.
ON / OFF push button for anchor meter01 No.
ON / OFF push button for homogenizer01 No.
Process timer switch01 No.
Potentiometer01 No.
Emergency push button01 No.
Steam ON selector switch01 No.
Machine lamp selector switch01 No.
B   Storage Vessel
Qty.01 No.
Gross capacity200 Ltrs.
ShellCylindrical with conical bottom
Product outlet50 mm (D) Discharge with valve
C   Jacketed Storage Vessel
1.0  Storage Vessel
Qty.01 No.
ShellCylindrical with conical bottom
Product outlet50 mm (D) Discharge with valve
Support structure04 Nos. AISI 304 pipes with stiffening and caster wheel
Nozzle for water inlet40 mm
Nozzle for water outlet40 mm
Jacket vent25 mm
2.0 Temperature Sensor
MakeNikesh Ind.
ModelPT 100,
Range0-400 0C
3.0  Electric Heater
TypeSS tubular, immersion            Heater
Power Rating 4 KW
Qty03 Nos
4.0   Digital Temp. Indicator Cum Controllers
MakeSlectron
ModelDTC 503
Power Rating270 VAC / 50-60 Hz
5.0  Pressure Gauge
MakeLA
Range0-10.6 Kg/cm2
Least Count2 Kg/cm2
6.0 Control Panel
TypeBox type
Main ON / OFF Switch01 No.
ON /OFF push button for electric heater01 No.

 

  • 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.
DescriptionSpecified
Power Consumption
GMV Agitator Motor3 HP
Homogenizer Motor10 HP
Filling Pump – 11 HP
Vacuum Pump3 HP
Cooling Water
Salts free cooling water150C for OMV and Mechanical Seal
Pneumatic Supply
Compressed Air Supply8 kg/cm2
  •  MATERIAL OF CONSTRUCTION
DescriptionSpecification
ShellAISI 316
Top DishAISI 316
JacketAISI 304
CladdingAISI 304
Supporting StructureAISI 304
Driven ShaftAISI 316
AnchorAISI 316
Homogenizer ShaftAISI 316
PipingAISI 316
Working PlatformAISI 304
Control PanelAISI 304
Torrospherical Top dish sealing GasketFood Grade White Silicon Gasket
scraperTeflon
Bottom cone of storage VesselAISI 316
  •  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
Sr. No.DescriptionDrawing No.
1General arrangement drawing of Ointment Manufacturing Vessel       

 

  • 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
cGMP Current Good Manufacturing Practices
GEPGood Engineering practices
FATFactory Acceptance Test
URSUser Requirement Specifications
SSStainless Steel
DQDesign Qualification
ACAlternate Current.
MSMild steel
PLCProgrammable Logic Control
MNPMatt Nickel Plated
KWKilo Watt
DQDesign Qualification
HzHeartz.
KgKilogram.
FATFactory acceptance test
C.I.Cast Iron
No.Number

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