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
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

 

For More Pharma Updates Visit –https://pharmaguidances.com