Installation Qualification of Gelatin Storage Vessel

  • To describe the Installation Qualification of Gelatin Storage Vessel 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 Gelatin Storage Vessel.
    • 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.
  • The following requirement / practices apply to Gelatin Storage Vessel 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.
  • The table below lists the tests to be performed as part of the Installation Qualification phase.
Documents & Drawings Verification
Verification of Technical Specification for

In-House & sub-components / bought out items

Utilities Verification
Material of construction verification
Critical Instruments 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 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.DescriptionDocument No.Sign.Date
1Installation, Operation and Maintenance Manual
2General arrangement drawing
  •  Conclusions / Comments:
  • Verification of Technical Specification for In-House & sub-components / Bought out items
  • Purpose – To verify that each major component of the Gelatin Storage Vessel 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 Gelatin Storage Vessel 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
DescriptionSpecificationMeets Spec. (Yes/No)Verification SourceSign.Date
1. Equipment Description
NameGelatin Storage Vessel
Surface Finishmirror (Internal) &  Matt (external)
Overall Dimension900 mm (D) X 960 mm(H)
Design ConditionShell: -1 to Atm. Bar g @120 0C

Jacket: FOW @120 0C

Nozzle07 Nos.

N1 : Outlet connection

N2 : Product Thermowell

N3 : Water Inlet

N4 : drain

N5 : Vent connection

N6 : Heater Connection

N7 : Level Glass

Main ShellShell :  600 X 625 X 3 mm Thick,

Heads: 1.6 mm (T) Detachable flat cover on top and Tapered bottom  flat cover with 5 mm (T)

JacketShell: 670 X 600 X 2.5 mm (T)

Closure: 4 mm (T)

InsulationType: RBFG, 50 mm (T)

Cladding: 2 mm (T), AISI        304 welded cladding

SupportAISI 304 Platform (04 Nos.) with SS castor wheel
CapacityWorking :- 150 L & Gross :-  170 L
MOCContact :-  AISI 316 L

Non – Contact :-  AISI 304

Gasket:- Silicon

2. Ball Valve for Outlet Connection
typeManual Ball Valve
size50 mm
End ConnectionT/C
typeManual Ball Valve
Sr. No.2253/06
3. Ball Valve for  Jacket Inlet Connection
typeManual Ball Valve
size25 mm
End ConnectionT/C
Sr. No.78/06
4. Temp. Sensor
TypePT-100, 3 Wire
Mounting½” BSP
Accuracy± 1 %
Range0-200 0C
Sr. No.19001497
5. Heater
typeWater Immersion Heater with Plug Pin
Power Rating2 KW / 230 V
Qty.02 Nos.
6. Thermostat
Qty.02 Nos.
Range25 to 150 0C
Power Supply240 Volts
MakeGirish Ego
Model210 C & 210
7. Temp. Indicator Cum Controller
Range0 – 200 0C
Power Supply230 Volts
Sr. No.
8. Castor Wheel
MOCSS castor wheel with PU coated nylon
TypePin Mounted
Qty.04 Nos.
  • Conclusions / Comments:
  • 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
DescriptionSpecifiedObservationInitial / Date


Potable WaterTo be provided
  • Conclusions / Comments:
  • Material of Construction Verification
    • Rationale – To verify that all assembly of Gelatin Storage Vessel 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 AISI 316 L & if the solution turns pink and immediately vanishes, then it is AISI 304.
  • Acceptance Criteria – All material of construction for the Gelatin Storage Vessel shall meet the MOC provided in Design Qualification.
  • Material of Construction verification Results
Part Description & SizeMaterialMeets

Spec. (Yes/No)

Verification SourceSign.Date
Main Shell (3 mm)AISI 316 L
Top Cover (1.6  mm)AISI 316 L
Body Flange (20 mm)AISI 316 L
Bottom cover (5 mm)AISI 316 L
Jacket Shell (2.5 mm)AISI 304
Jacket Closer (4 mm)AISI 304
Jacket Bottom Cover (2.5 mm)AISI 304
Insulation Shell (2 mm)AISI 304
Rod for N1 (75 mm)AISI 316 L
Rod for N2 (30 mm)AISI 316 L
Rod for N3, 4, 5 (35 mm)AISI 304
Rod for N6, 7 (65 mm)AISI 304
‘o’ Ring for T/C, 2”Silicon
Level Glass (5 mm X 30 mm)Toughen glass
  •  Conclusions / Comments:
  • Critical Instruments Calibration Verification
    • Rationale – To verify that all critical instruments for the Gelatin Storage Vessel has been calibrated before starting the Operational Qualification.
  • 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.
  • Acceptance Criteria – All critical instrumentation for the Gelatin Storage Vessel shall be in a state of calibration.
  • Instrumentation List Results
DescriptionMakeModelSerial  No.Certificate No.Current Calibration
Yes/NoSign / Date
Temperature Sensor
  • Conclusions / Comments:
  • Installation Qualification Tests Status
  • The table below lists the tests performed and related results.
Test Number


Critical Feature


PassFailDeviation Found
Documents & Drawings Verification
Verification of Technical Specification for In-House & Sub-contract / bought out items.
Utilities Verification
Material of Construction Verification
Critical Instruments Calibration Verification
  • Data Analysis, Summary of IQ & Recommendations

Sr. No.

Item Name


Signature and Date

About Pharma Editor

Check Also


VIAL WASHING MACHINE PQ PROTOCOL TABLE OF CONTENTS S. No. Description 1.0 Protocol approval 2.0 …