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

Description	Specification
A         Ointment Manufacturing Vessel
1. Ointment Manufacturing Vessel
Model	GMV 400 Liters
Make
Dimension	2100 mm (L) X 2100 mm (H) X 1200 mm(W)
Design conditions	Jacket: 3 kg/cm2  – working 4.5 kg/cm2  – Test Shell:   3 kg/cm2  – working 4.5 kg/cm2  – Test At 600 mmHg of vacuum
Finish	Internal–  Mirror External – Matt
Capacity	400 Liters (Gross) 350 Liters (Working )
Cladding	14 SWG, AISI 304
Shell	Cylindrical with flat bottom, 6 mm Thickness, AISI 316 with lift up type lid opening
Baffles	2 Nos.
Supporting Structure	SS Pipes support mounted on floor
Scrapper	Teflon scrapper bolted to anchor
2. Nozzle for jacket
Qty.	03 Nos.
Steam inlet and cooling water outlet	25 NB
Steam outlet and cooling water inlet	25 NB
Jacket vent	25 mm (d) with plug
3. Nozzle for vessel
Qty.	10 Nos.
Charge hole	150 mm (D)
Sight glass	100 mm (D)
Vacuum Nozzle	25  mm threaded type with vacuum breakers & valves
Discharge	50 mm with flush bottom full bore valve on side
Temp. sensor port	Sensor port for pt – 100 sensor
Charging hopper	25 mm flange type nozzle with 10 liters capacity hopper
Oil phase	25 mm (D) with valve
Water phase	25 mm (D) with valve
Light glass	100 mm (D) with light fixture
Recirculation	50 mm (D), SS 316 pipe with shaft sealing
4. Agitator
Agitator	Anchor type
MOC	SS 316
Dimensions	80 mm (L) X 16 mm (T)
Shaft	50 mm (D),  SS 316 with Shaft Sealing
5. Motor  (Gelatin Mixing Vessel)
Make	Hindustan Motors
Type	3 Ph, induction motor, STD TEFC electric motor
Power Rating	3 HP / 2.2 KW / 50 Hz / 415 V / 1425 RPM
Make	Hindustan Motors
6.Gear Box
Make	Greaves
Type	V 500 ZW
Ratio	50:1
7. Motor (Homogenizer)
Make	Hindustan Motors
Type	3 Ph, induction motor, STD TEFC electric motor
Power Rating	10 HP / 7.5 KW / 50 Hz / 415 V / 1440 RPM
8. Filling Pump
Make	Positive Metering Pumps
Model	PL3530GMP
Type	Plunger / Reciprocating type
Power Rating	1 HP
Capacity	0 – 600 LPH
9. Filling Pump Motor
Make	Hindustan Motors
Type	3 Ph, induction motor, STD TEFC electric motor
Power Rating	1 HP / 415 V / 1405 RPM
10.Temperature Sensor
Make	Nikesh Ind.
Model	PT 100,
Range	0-400 0C
11. Temp. Indicator cum controller for main vessel
Make	Selectron
Type	DTC 203
Incoming signal	RTD PT – 100, 3 Wire
Voltage	230 vAC / 50 Hz
12. RPM Indicator for Anchor
Make	Selectron
Type	PIC 101
Power Rating	230 VAC / 50 Hz
13.  RPM Indicator for Homogenizer
Make	Selectron
Type	PIC 101
Power Rating	230 VAC / 50 Hz
14.Timer For Homogenizer
Make	Selectron
Type	XT 56
Power Rating	230 VAC
Make	Selectron
15.              Pressure gauge
Make	LA
Range	0-10.6 Kg/cm2
Least Count	2 Kg/cm2
16. Water Level Controller
Make	Minilec
Model	WLC D1
Supply	240 V
17. Variable Frequency Drive (Anchor)
Make	Allen Bradley
Model	Power Flex 4
Power Rating	3 HP / 3 PH / 415 VAC
18. Variable Frequency Drive (Homogenizer)
Make	Allen Bradley
Model	Power Flex 40
Power Rating	10 HP / 3 PH / 415 VAC
19.Control Panel
RYB phase indicator	01 No.
RPm meter for anchor & homogenizer	01 No. each
Process timer	01 No.
ON / OFF push button for anchor meter	01 No.
ON / OFF push button for homogenizer	01 No.
Process timer switch	01 No.
Potentiometer	01 No.
Emergency push button	01 No.
Steam ON selector switch	01 No.
Machine lamp selector switch	01 No.
B   Storage Vessel
Qty.	01 No.
Gross capacity	200 Ltrs.
Shell	Cylindrical with conical bottom
Product outlet	50 mm (D) Discharge with valve
C   Jacketed Storage Vessel
1.0  Storage Vessel
Qty.	01 No.
Shell	Cylindrical with conical bottom
Product outlet	50 mm (D) Discharge with valve
Support structure	04 Nos. AISI 304 pipes with stiffening and caster wheel
Nozzle for water inlet	40 mm
Nozzle for water outlet	40 mm
Jacket vent	25 mm
2.0 Temperature Sensor
Make	Nikesh Ind.
Model	PT 100,
Range	0-400 0C
3.0  Electric Heater
Type	SS tubular, immersion            Heater
Power Rating	4 KW
Qty	03 Nos
4.0   Digital Temp. Indicator Cum Controllers
Make	Slectron
Model	DTC 503
Power Rating	270 VAC / 50-60 Hz
5.0  Pressure Gauge
Make	LA
Range	0-10.6 Kg/cm2
Least Count	2 Kg/cm2
6.0 Control Panel
Type	Box type
Main ON / OFF Switch	01 No.
ON /OFF push button for electric heater	01 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.

Description	Specified
Power Consumption
GMV Agitator Motor	3 HP
Homogenizer Motor	10 HP
Filling Pump – 1	1 HP
Vacuum Pump	3 HP
Cooling Water
Salts free cooling water	150C for OMV and Mechanical Seal
Pneumatic Supply
Compressed Air Supply	8 kg/cm2

•  MATERIAL OF CONSTRUCTION

Description	Specification
Shell	AISI 316
Top Dish	AISI 316
Jacket	AISI 304
Cladding	AISI 304
Supporting Structure	AISI 304
Driven Shaft	AISI 316
Anchor	AISI 316
Homogenizer Shaft	AISI 316
Piping	AISI 316
Working Platform	AISI 304
Control Panel	AISI 304
Torrospherical Top dish sealing Gasket	Food Grade White Silicon Gasket
scraper	Teflon
Bottom cone of storage Vessel	AISI 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.	Description	Drawing No.
1	General 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
GEP	Good Engineering practices
FAT	Factory Acceptance Test
URS	User Requirement Specifications
SS	Stainless Steel
DQ	Design Qualification
AC	Alternate Current.
MS	Mild steel
PLC	Programmable Logic Control
MNP	Matt Nickel Plated
KW	Kilo Watt
DQ	Design Qualification
Hz	Heartz.
Kg	Kilogram.
FAT	Factory acceptance test
C.I.	Cast Iron
No.	Number

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