Installation qualification of Gelatin Melting Reactor

Installation qualification of Gelatin Melting Reactor

PURPOSE:

To describe the Installation Qualification of the Gelatin Melting Reactor and its accessories and to define the Specification of the system:

Ensure that the equipment meets the specifications 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 pieces of equipment will be installed under current Good Manufacturing Practices.

SCOPE:

The scope of this document applies to the installation qualification of the Gelatin Melting Reactor.

RESPONSIBILITIES:

It is the responsibility of the Manufacturer to perform all the specifications verification checks and tests concerning installation qualification and compiling data in coordination with the client.

It is the responsibility of the client to check and approve the installation qualification.

PROCEDURE:

The following requirements/practices apply to, Gelatin Melting Reactor Installation Qualification activities:

Verify that systems are installed by 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 labeled with a unique ID number.

INSTALLATION QUALIFICATION TESTS:

The table below lists the tests to be performed as part of the Installation Qualification phase.

CRITICAL FEATURE
Documents & Drawings Verification
Verification of Technical Specifications for In-house & sub-components / bought-out items
Utility Verification
Material of construction verification
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 below are 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 conform 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.

Description
Installation, Operation, and Maintenance Manual
General arrangement drawing

Verification of Technical Specifications for In-House & sub-components / Bought out items

Purpose

To verify that each major component of the, 300 L Gelatin Melting Reactor is 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 the 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 the design qualification and on the latest revision of drawings must be present, documented, and tagged.

Major Components Results

Utility Verification

Rationale – To verify that all necessary utilities are correctly installed.

Procedure – Confirm that utility 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.

Utility Specification Results

Description
Electrical connection
Vacuum
Hot Water
Compressed Air

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 the battery & keep the anode at one end of the material and the cathode at the 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
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

Critical Instrument Calibration Verification

Rationale – To verify that all critical instruments for the Pharmalab, 300 L Gelatin Melting Reactor have been calibrated before starting the Operational Qualification.

Test equipment – Calibrated 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 Set point Operating Range
Pressure Gauge (Hydraulic Power pack) Mass 0 – 160 Kg / cm2
Pressure Gauge for Jacket Wika 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 0 2500C

Installation Qualification Tests Status

The table below lists the tests performed and related results.

Critical Feature (Verification of Technical Specifications for In-House & Sub-contract / bought-out items.)
Utility Verification
Material of Construction Verification
Critical Instruments Calibration verification

Data Analysis, Summary of IQ & Recommendations

Note: Any changes made in the system must be recorded in this sheet.

CONCLUSION

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