Home / Validation & Qualification / Qualification / Installation Qualification(IQ) / Installation Qualification of Gelatin Storage Vessel

Installation Qualification of Gelatin Storage Vessel

  • PURPOSE:
  • 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.
  • 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 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.
  • INSTALLATION QUALIFICATION TESTS:
  • The table below lists the tests to be performed as part of the Installation Qualification phase.
TEST NUMBER CRITICAL FEATURE
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. Description Document No. Sign. Date
1 Installation, Operation and Maintenance Manual
2 General 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
Description Specification Meets Spec. (Yes/No) Verification Source Sign. Date
1. Equipment Description
Name Gelatin Storage Vessel
Surface Finish mirror (Internal) &  Matt (external)
Overall Dimension 900 mm (D) X 960 mm(H)
Design Condition Shell: -1 to Atm. Bar g @120 0C

Jacket: FOW @120 0C

Nozzle 07 Nos.

N1 : Outlet connection

N2 : Product Thermowell

N3 : Water Inlet

N4 : drain

N5 : Vent connection

N6 : Heater Connection

N7 : Level Glass

Main Shell Shell :  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)

Jacket Shell: 670 X 600 X 2.5 mm (T)

Closure: 4 mm (T)

Insulation Type: RBFG, 50 mm (T)

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

Support AISI 304 Platform (04 Nos.) with SS castor wheel
Capacity Working :- 150 L & Gross :-  170 L
MOC Contact :-  AISI 316 L

Non – Contact :-  AISI 304

Gasket:- Silicon

2. Ball Valve for Outlet Connection
type Manual Ball Valve
size 50 mm
MOC AISI 316 L
End Connection T/C
Make Seeco
type Manual Ball Valve
Sr. No. 2253/06
3. Ball Valve for  Jacket Inlet Connection
type Manual Ball Valve
size 25 mm
MOC AISI 316 L
End Connection T/C
Make Seeco
Sr. No. 78/06
4. Temp. Sensor
Type PT-100, 3 Wire
Mounting ½” BSP
Accuracy ± 1 %
Range 0-200 0C
Make Radix
Sr. No. 19001497
5. Heater
type Water Immersion Heater with Plug Pin
Power Rating 2 KW / 230 V
Qty. 02 Nos.
6. Thermostat
Qty. 02 Nos.
Range 25 to 150 0C
Power Supply 240 Volts
Make Girish Ego
Model 210 C & 210
7. Temp. Indicator Cum Controller
Range 0 – 200 0C
Power Supply 230 Volts
Make Radix
Sr. No.
8. Castor Wheel
MOC SS castor wheel with PU coated nylon
Type Pin Mounted
Diameter 4”
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
Description Specified Observation Initial / Date

mm/dd/yy

Potable Water To 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 & Size Material Meets

Spec. (Yes/No)

Verification Source Sign. 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
Description Make Model Serial  No. Certificate No. Current Calibration
Yes/No Sign / Date
Temperature Sensor
  • Conclusions / Comments:
  • Installation Qualification Tests Status
  • The table below lists the tests performed and related results.
Test Number

 

Critical Feature

 

Pass Fail Deviation Found
Yes No
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
  • AMENDMENT RECORD

Sr. No.

Item Name

Remarks

Signature and Date

About Pharma Editor

Check Also

All Post URL of Drugs formulations

All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of …