Installation Qualification of Medicament Preparation Vessel

  • PURPOSE:
  • To describe the Installation Qualification of Medicament Preparation 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 Medicament Preparation Vessel.
  • RESPONSIBILITIES:
    • It is the responsibility of the Manufacturer to prepare Installation Qualification Protocol as per Design Qualification.
    • It is the responsibility of the client to check and approve the installation qualification protocol.
    • 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.
  • PROCEDURE:
  • The following requirement / practices apply to Medicament Preparation 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
  • 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 Utilities Verification
5.4 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.
    • 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 Medicament Preparation 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 Medicament Preparation 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 Medicament Preparation Vessel
Surface Finish mirror (Internal)

Matt (external)

Capacity 150 L
Overall Dimension 780 mm (D) X 1150 mm(H)
Nozzle 05 Nos.

N1 : Outlet Connection

N2 : Jacket Connection

N3 : Jacket Connection

N4 : Jacket Vent Connection

N5 : Dial type Temp. Gauge

Connection

 

 

 

 

 

 

Insulation RBFG type, 50 mm (T), 2 mm (T) SS 304 cladding
Support AISI 304 legs (04 Nos.) with SS castor wheel
Capacity Working :- 150 L

Gross :-  170 L

MOC Contact :-  AISI 316 L

Non – Contact :-  AISI 304

Gasket:- Silicon

Design Condition Shell: -1 to Atm.Bar g@1200C

Jacket :- -2.5 Bar g@1200C

2. Flush Ball Valve for Product Outlet
Type Manual Ball Valve
Make Seeco
Sr. No. 24 / 06
Size 1 ½ ”
Mounting Pad Welded
MOC AISI 316 L
3. Vent Valve for Jacket
Type Manual Ball Valve
Make Seeco
Sr. No. 12 / 06
Mounting 3/8”
MOC AISI 304
4. Castor Wheel
MOC SS castor with PU coated nylon wheel
Qty. 04 Nos.

Swivel: 02 Nos.

Brake : 02 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

Hot Water To be provided
Chilled Water To be provided
Steam To be provided
  • Conclusions / Comments:
  • Material of Construction Verification
    • Rationale – To verify that all assembly of Medicament Preparation 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 150 L Medicament Preparation 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, 4 mm AISI 316 L
Top Cove, 1.6 mm AISI 316 L
Body Flange, 20 mm AISI 316 L
Bottom Dish, 4 mm AISI 316 L
Jacket Shell, 3 mm AISI 304
Jacket Dish, 3 mm AISI 304
Jacket Closer, 5 mm AISI 304
Jacket Stiffener, 3 mm AISI 304
Insulation Shell, 1.6 mm AISI 304
Pipe for Leg, 2” NB x Sch.10 AISI 304
Pipe for N2, 3, 1” NB x Sch.40 AISI 304
Plate flange for N2 & N3, 16 mm AISI 304
Tube for N4, 5/8” O.D. x 16 SWG AISI 304
Rod for  N4, 35 mm AISI 304
Rod for  N5, 35 mm AISI 304
‘O’ Ring Food Grade Transparent Silicon Rubber
  • 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 Utilities Verification
5.4 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.

 

  • CONCLUSION

 

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