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Installation qualification of 300 L Gelatin Melting Reactor

  • PURPOSE:
  • To describe the Installation Qualification of 300 L Gelatin Melting Reactor its accessories and to define the Specification of the system in order to:
  • Ensure that the equipment meets the specification as per Design Qualification.
  • Aid verification of the installation as per equipment general arrangement Drawing.
  • Ensure that the system installation meets acceptance criteria.
  • Ensure that the equipments will be installed in accordance with current Good Manufacturing Practices.
  • SCOPE:
  • The scope of this document applies to the installation qualification of 300 L Gelatin Melting Reactor.
  • RESPONSIBILITIES:
  • It is the responsibility of the Manufacturer to perform all the specifications verification checks and tests with respect to installation qualification and compiling data in co-ordination with client.
  • It is the responsibility of the client to check and approve the installation qualification.
  • PROCEDURE:
  • The following requirement / practices apply to, 300 L Gelatin Melting Reactor Installation Qualification activities:
  • Verify that systems are installed in accordance with approved engineering drawings and documents, which shall include the following.
  • General arrangement drawing.
  • Installation specification.
  • Equipment manuals
  • Verify that the equipment and instrumentation are clearly described as per vendor, model, capacity, materials of construction and any critical criteria.
  • Verify that major components are tagged or labelled with a unique ID number.
  • INSTALLATION QUALIFICATION TESTS:
  • The table below lists the tests to be performed as part of the Installation Qualification phase.
TEST NUMBER CRITICAL FEATURE
5.1 Documents & Drawings Verification
5.2 Verification of Technical Specification for

In-House & sub-components / bought out items

5.3 Utilities Verification
5.4 Material of construction verification
5.5 Critical Instrument Calibration Verification
  • Documents & Drawings Verification
  • Rationale – To verify that the documentation provides complete and correct technical references and permits servicing of the units.
  • Test equipment – None Required.
  • Procedure – Verify that the required documents and drawings listed in the table 5.1.5 is available.Review the documents and drawings for completeness and exactness with the installed units. Attach the copies of the drawings to this document or reference the location from where they can be easily retrieved. Any items in the installation, which are not conforming to the corresponding drawings, must be commented on in the appropriate space. List the non-conformances and the reasons for them in an attachment if necessary.
  • Acceptance Criteria – The documents must be accurate and complete. The drawing information must correspond to the physical installation.
  • Documentation Verification Results.
Sr. No. Description Document No. Verified By Date
1 Installation, Operation and Maintenance Manual
2 General arrangement drawing
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Verified By:     _______________________           Date:   ______________
  • Reviewed By:            ________________________            Date:     ______________
  • Verification of Technical Specification for In-House & sub-components / Bought out items
  • Purpose
  • To verify that each major component of the, 300 L Gelatin Melting Reactor are present and identified.
  • Test Equipment – None Required
  • Procedure
  • Confirm that identification nameplates have been applied to the units and that these indicate the following (where applicable).
  • – Type
  • – Identification (Tag) No.
  • – Manufacturer
  • – Model Number
  • Confirm that the various components of, 300 L Gelatin Melting Reactor are present and tagged as per specifications and drawings, in the proper number and configuration.
  • Note any deviations or discrepancies and recommend follow up action if required.
  • Acceptance Criteria
  • All units and parts specified in design qualification and on latest revision of drawings must be present, documented and tagged.
  • Major Components Results
Description Specification Meets

Spec. (Yes/No)

Verification Source Sign. Date
1.                  Equipment Description
Name 300 L Gelatin Melting Reactor
Job No. V – 060008
Model 300 Ltrs. GMR
Capacity Working : 300 L

Gross : 440 L

Make Pharmalab
Design condition Shell : -1 to ATM bar g @

130ºC

Jacket :- 3 bar g @ 150ºC

Surface Finish mirror (Internal)

Matt (External)

Agitator Anchor Type, with side  Teflon Scrapper
Platform Dimension 3020 mm(L) X 2740 mm(W)
Platform Height From Ground 2200 mm
Total Height of System 3440 mm
Discharge Height from ground 1420 mm
Safety Railing Height from Platform 915 mm
2.                  Mechanical Seal
Make Burgmann
Type Single Mechanical Seal
Sr. No.
Size 75 mm
3.                  Stirrer Motor
Make SEW – Eurodrive
Type SAF 87 DV 132S4
Sr. No.
Power Rating 5.5 KW/7.5 HP / 415 V / 1430 RPM
Output RPM 52
4.                  3 Way control Valve for HWS
Type Pneumatic control ball valve
Size 25 NB
Rating ASME 150 #
Actuator (Double acting) MD 50 – F04
System Tag No. CV 40152
Operating Pressure 80 PSI
Sr. No.
Make Micro Pneumatics
5.                  Vacuum Pump Motor (M1)
Type 3 Phase Induction Motor
Make Crompton Greaves
Sr. No.
Power Rating 3.7 KW / 5 HP  / 415 V / 2840 RPM
6.                  Vacuum Pump Motor (M2)
Type 3 Phase Induction Motor
Make Crompton Greaves
Sr. No.
Power Rating 3.7 KW / 5 HP  / 415 V / 2840 RPM
7.                  Vacuum Pump
Type VWS 500
Make PPI Systems
Sr. No.
Power Rating 5 HP / 2880 Rpm
Capacity 50 m3/ hr.
8.                  Vacuum Pump
Type VWS 500
Make PPI Systems
Sr. No.
Power Rating 5 HP / 2880 Rpm
Capacity 50 m3/ hr.
9.                  Vacuum Gauge
Make Arihant
Range -760  to 0 mm Hg
Least Count 10 mm Hg
Location Vacuum Pump Motor (M1)
10.              Vacuum Gauge
Make HTI
Range -760  to 0 mm Hg
Least Count 10 mm Hg
Location Vacuum Pump Motor (M2)
11.              Flow Regulator
Make Mascon
Type BSP
Sr. No.
Location Vacuum Pump Motor (M1)
12.              Motor (Hydraulic Power Pack)
Type 3 Phase Induction Motor
Make Crompton Greaves
Machine No. NDA 4DVJ
Power Rating 0.75 KW / 1 HP  / 415 V / 1410 RPM
13.              Pressure Gauge
Make Mass
Sr. No.
Range 0 – 160 Kg / cm2
Least Count 2 Kg / cm2
Location Hydraulic Power Pack Motor
14.              Flow Control Valve
Make Flowtec
Type TVC 8 – ¼”
Regulator Range 0 – 9
Location Hydraulic Power Pack Motor
15.              Solenoid Valve
Make Rexroth
Sr. No.
Model 09W06
Location Hydraulic Power Pack Motor
16.              Ball valve for Air Vent
Size ½”
make Seeco
Sr. no.
17.              2 Way Control Valve for HWR
Type Pneumatic control ball valve
Size 25 NB
Rating Asme 150 #
Actuator (Double acting) MD – 40 – F – 03
System Tag No. CV 40139
Operating Range 80 PSI
Sr. No.
Make Micro Pneumatics
18.              2 Way Control Valve for Vacuum
Type Pneumatic control ball valve
Size 25 NB
Rating PN 10
Actuator (Double acting) MD – 40 – F – 03
Operating Range 80 PSI
Sr. No.
Make Micro Pneumatics
19.              ‘Y’ Type Flush bottom Valve
Size 65 X 64
End Connection T / C
Sr. No.
20.              Ball Valve for Liquid Suction
Type Single piece ball valve
Size 1”
21.              Ball Valve for Gelatin Suction
Type Single piece ball valve
Size 50 mm
End Connection T / C
Sr. No.
22.              Pressure Switch
Make Indfos
Sr. No.
Type RT 116
23.              Temp. Sensor
Type PT – 100, 3 wire type
Sr. No.
Make Radix
Range 0 – 2500C
24.              Vacuum sensor  cum Transmitter
Range -1 to 0 Bar
Power Rating 10 – 30 VDC
Sr. No.
Make Wika
Model UT – 10
Location Detachable Top Dish
25.              Pressure Gauge for Jacket
Make Wika
Sr. No.
Range 0 -10 Kg/cm2
Model EN 837 – 1
26.              FRL Unit
Type LFR – D – Mini
P1 max. 16 bar
P2 max. 12 bar
Make Festo
Model 159605 U 223
Location Control Panel
27.              Pressure Gauge
Make Festo
Range 0-16 bar
Least Count 0.2 bar
Sr. No.
Location FRL Unit
28.              Solenoid Valve
Make Festo
Model MFH – 5 – 1/8
Operating Pressure 1.8  – 8 bar
Qty. 04 Nos.
29.              Control Panel
R,Y,B Phase Indicator 01 No. each
Touch Screen 01 No.
Start Push Button 01 No.
Emergency Push Button 01 No.
Main ON / OFF Switch 01 No.
Location Platform
30.              Programmable Logical controller (PLC)
Make Allen Bradley
Model Micro logics 1200
Input 14 Nos.
Relay Output 10 Nos.
31.              Halogen Lamp
Make Philips
power Rating 50 W / 12 V
32.              Variable Frequency Drive (VFD)
Make Allen Bradley
Model Power Flex 40
Cat No. 22B – DO 12 N 104
Sr. No.
Motor Rating 5.5 kw / 7.5 HP
Power Rating Input : 3 Phase / 380 – 480 V

Output : 3 Phase / 0 – 400 V

33.              Spray Ball
Size 20 mm
Make Pharmalab
34.              Safety Valve for Jacket
Size 20 NB
Type Spring loaded
Make Seeco
Sr. No.
35.              Touch Screen
Model Prizm – 285
Make Renu Elec.
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Verified By:     _______________________           Date:   ______________
  • Reviewed By:            ________________________            Date:     ______________
  • Utilities Verification
  • Rationale – To verify that all necessary utilities are correctly installed.
  • Procedure – Confirm that utilities connections are configured as per specification and in compliance with local codes. Record the results in the table below. Note any deviations or discrepancies.
  • Acceptance Criteria
  • All services and connections must be installed and documented.
  • Utilities Specification Results
Description Observation Initial / Date

mm/dd/yy

Electrical connection
Vacuum
Hot Water
Compressed Air
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Verified By:     _______________________           Date:   ______________
  • Reviewed By:            ________________________            Date:     ______________
  • Material of Construction Verification
  • Rationale – To verify that all assembly of Pharmalab, 300 L Gelatin Melting Reactor has been manufactured as per the specification provided by the customer based on the MOC certificates supplied by the vendor / moly testing unit.
  • Test equipment – Moly testing unit (To identify AISI 304 and AISI 316 L materials)
  • Procedure – Put a drop of Molybdenum solution on the material to be tested. Take battery & keep anode at one end of the material and cathode at Moly drop. If the solution turns pink and stays for around one minute, then it is SS 316 L & if the solution turns pink and immediately vanishes, then it is SS 304
  • Acceptance Criteria
  • All material of construction for the Pharmalab, 300 L Gelatin Melting Reactor shall meet the MOC provided in Design Qualification.
  • Material of Construction verification Results
Description Specification Meets

Spec. (Yes/No)

Verification Source Sign. Date
Main Shell (5 mm) aisi 316 L
Top Dish (5 mm) aisi 316 L
Bottom Dish (6 mm) TP 316 L
Body Flange (35 mm) aisi 316 L
Jacket Shell (4 mm) SA 240, TP 304
Jacket Dish (4 mm) SA 240, TP 304
Stiffener (5 mm) SS 304
Insulation Shell (2 mm) SS 304
Cover for hand hole (14 mm) AISI 316 L
Rod for N1, 3A, 3B, 4, 5, 6

(56 mm )

AISI 316 L
Rod for Nozzle N2

(65 mm )

AISI 316 L
Pipe for liquid suction

(1” od X 16 G)

AISI 316 L
Pad Plate for L.G. Nozzle – 8

(35 mm)

AISI 316 L
Cover for L.G. and S.G.(16 mm) AISI 304
Pipe for Nozzle 9, 10

(1” NB X SCH 40)

AISI 304
Plate flange for Nozzle 9, 10 ( 16 mm) AISI 304
Rod for Nozzle 10,11 (65 mm) AISI 304
Pipe for Nozzle 11 ¾” O.D. X 16 SWG SS 304 (ASTM A 249)
Rod for thermowell (13 mm) AISI 316 L
Pad Plate for Agitator (45 mm) AISI 316 L
Plate for Agitator ( 8 mm) AISI 316 L
Shaft for Top Agitator (75 mm) AISI 316 L
Shaft for Bottom Agitator

(95 mm)

AISI 316 L
‘O’ Ring(1”, 1 1/2”,2”) Food Grade Silicon Transparent Rubber
Body Flange Gasket (850 X 750 X 3 mm) White silicon
Site Glass (12 mm) Toughened glass
Light Glass ( 12 mm) Toughened glass
Scrapper Teflon
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Verified By:     _______________________           Date:   ______________
  • Reviewed By:            ________________________            Date:     ______________
  • Critical Instrument Calibration Verification
  • Rationale – To verify that all critical instruments for the Pharmalab, 300 L Gelatin Melting Reactor has been calibrated before starting the Operational Qualification.
  • Test equipment – Calibrated Dead Weight Pressure Standard
  • Procedure – Verify that all critical instruments are calibrated using an approved procedure, against a traceable standard. Note any deviations or discrepancies and recommend follow up actions if required. For all critical instruments, attach copies of calibration certificates to this protocol.
  • Acceptance Criteria
  • All critical instrumentation for the Pharmalab, 300 L Gelatin Melting Reactor shall be in a state of calibration.
  • Instrumentation List Results
Description Make Model Sr.  No. Set point Operating Range Current

Calibration

Yes /No Sign / Date
Pressure Gauge (Hydraulic Power pack) Mass 0 – 160 Kg / cm2
Pressure Gauge for Jacket Wika EN 837 – 1 0 – 10 Kg / cm2
Pressure Gauge Festo 0 – 16 bar
Vacuum Sensor Cum Transmitter Wika -1 to 0 bar
Vacuum Gauge (M1) Arihant -760 to 0 mm Hg
Vacuum Gauge (M2) HTI -760 to 0 mm Hg
Temp. Sensor with head mounted Transmitter Radix PT – 100 0 2500C
  • Conclusions / Comments:
  • PASS                                     FAIL
  • Verified By:     _______________________           Date:   ______________
  • Reviewed By:    ________________________            Date:     ______________
  • Installation Qualification Tests Status
  • The table below lists the tests performed and related results.
Test Number

 

Critical Feature

 

Pass Fail Deviation Found
Yes No
5.1 Documents & Drawings Verification
5.2 Verification of Technical Specification for In-House & Sub-contract / bought out items.
5.3 Utilities Verification
5.4 Material of Construction Verification
5.5 Critical Instruments Calibration verification

 

  • Data Analysis, Summary of IQ & Recommendations
  • AMENDMENT RECORD
Sr. No. Item Name Remarks Signature and Date
  • Note: Any changes made in the system must be recorded in this sheet.
  • CONCLUSION

 

  • Prepared by                               Reviewed By                                               Approved by

 

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