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Installation Qualification of Raw Gelatin Storage Vessel

  • PURPOSE:
  • To describe the Installation Qualification of Raw 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 Raw 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 Raw 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
5.1 Documents & Drawings Verification
5.2 Verification of Technical Specification for

In-House & sub-components / bought out items

5.3 Material of construction 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. 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 Raw 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 Raw 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 Raw Gelatin Storage Vessel
Surface Finish mirror (Internal)

Matt (external)

Overall Dimension 900 mm (D) X 1130 mm(H)
Nozzle 02 Nos.

N1 : Outlet connection

N2 : Vent connection

Main Shell Shell : 760 X 180 X 2.5 mm Heads : 1.6 mm (T)

Detachable flat cover

on top and 2.5 mm

(T) conical dish at

bottom

Support AISI 304 legs (04 Nos.) with SS castor wheel
Capacity Working :- 150 L

Gross :-  165 L

MOC Contact :-  AISI 316 L

Non – Contact :-  AISI 304

Gasket:- Silicon

2. Butterfly Valve
Type Manual Butterfly Valve with triclover ends
Make Mondentic
Sr. No. 525
Size 50.80 mm
MOC AISI 316 L
Gasket EPDM
3. Ball Valve for Vent
Type Manual Ball Valve with triclover ends
Make Mondentic
Sr. No. 306/06
Size 3/4”
MOC SS 316 L
4. Castor Wheel
MOC SS castor with PU coated nylon wheel
Type Pin Mounted
Qty. 04 Nos.
  • Conclusions / Comments:
  • Material of Construction Verification
  • Rationale – To verify that all assembly of Raw 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 Raw 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, 2.5 mm AISI 316 L
Top Cover, 1.6 mm AISI 316 L
Bottom Cone, 2.5 mm AISI 316 L
Pipe for Leg, 40 NB x Sch.10 AISI 304
Rod for N1, 75 mm AISI 316 L
Rod for N2, 35 mm AISI 316 L
‘o’ Ring for T/C, 2” Silicon
  •  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
5.1 Documents & Drawings Verification
5.2 Verification of Technical Specification for In-House & Sub-contract / bought out items.
5.3 Material of Construction 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.

 

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