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.

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.

Sr. No.	Description	Document No.	Sign.	Date
1	Installation, Operation and Maintenance Manual
2	General arrangement drawing

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.

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.

Description	Specification	Meets Spec. (Yes/No)	Verification Source	Sign.	Date
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.

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.

Test Number	Critical Feature	Pass	Fail	Deviation Found
Test Number	Critical Feature	Pass	Fail	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

Sr. No.	Item Name	Remarks	Signature and Date

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