SOP for Installation Qualification of Capsule Printing machine

SOP for Installation Qualification of Capsule Printing machine

  • PURPOSE
  • To describe the Installation Qualification of Capsule printing machine, 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 equipment’s will be installed in accordance with current Good manufacturing Practices.
  • SCOPE
  • The scope of this document applies to the installation qualification of Capsule printing machine.
  • RESPONSIBILITIES
  • It is the responsibility of the Manufacturer to prepare the 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 Capsule printing machine 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; and
  • 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.
TEST NUMBER CRITICAL FEATURE
1 Documents & Drawings Verification
2 Verification of Technical Specification for

In-House & sub-components / bought out items

3 Utilities Verification
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 in the table  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 conforming to the corresponding drawings, must be commented on in the appropriate space. List the non-conformance 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. Verified By Date
1 Installation, Operation and Maintenance Manual
2 General arrangement drawing
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Checked By: ________________________                       Date:   ______________
  • Verified By:   ________________________                       Date:   ______________
  • Verification of Technical Specification for In-House & sub-components / Bought out items
  • Purpose – To verify that each major component of the Capsule printing machine 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)
  • Manufacturer
  • Model Number – Confirm that the various components of Capsule printing machine 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 Capsule printing machine
Make Parle Pharma Machineries
Model Scorpio PPMPT
Sr.No. 102
Overall dimensions 1820(H)X1210(W)X1180(L)[mm]
Inclined Control Hand wheel 02 No’s
2.                  Main  Motor
Type 3 Phase induction motor
Model BN80 B4
Sr. No. 605923
RPM 1400
Power Rating 0.75KW /  230 V / 50Hz
Make Bonfliglioli Riduttori
3.                  Indexing Gear Box
Type AS25/P P90
Code 97667
Mount Pos. B3
Ratio 93
Make Bonfliglioli
4          Main Gear Box
Type WSS/UF  CI HS RS
Code 132379
Mount Pos. B3
Ratio 10
Make Bonfliglioli
5          VFD
Model ATV11HU18M2A
Sr.No. 145193120023
Power Rating 0.75KW,200/240V,

50/60Hz

Make Telemecanique
6          Control Panel
Start Push Button 01 No.
Stop Push Button 01 No.
Auto/Jog Rotary Switch 01 No.
Jog Push Button 01 No.
Emergency Stop 01 No.
Speed Adjustor Knob with Lock 01 No.
7          Air Switch
Qty 02No’s
Solenoid Valve 01 each
8           Pressure Gauge
Range 0-10 kg / cm2
Least Count 0.2 kg / cm2
Make Legris
Calibration Status Calibrated
Location FRL Unit
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Checked By: ________________________                       Date:   ______________
  • Verified By:   ________________________                       Date:   ______________
  • 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

Electrical connection To be provided
Compressed Air To be provided
  • Conclusions / Comments:
  • PASS                                    FAIL
  • Checked By: ________________________                       Date:   ______________
  • Verified By:   ________________________                       Date:   ______________
  • Material of Construction Verification  
  • Rationale – To verify that all assembly of Capsule printing machine has been manufactured as per the specification provided by the customer.
  • Test equipment – Moly testing unit (To identify SS 304 and SS 316 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 SS 316 & if the solution turns pink and immediately vanishes, then it is SS 304
  • Acceptance Criteria – All material of construction for the Capsule printing machine shall meet the MOC provided in Design Qualification. Material other than SS 316 and SS 304 are verified based on their material testing certificates provided by the Manufacturer.

 

  • Material of Construction verification Results
Description Specification Meets

Spec. (Yes/No)

Verification Source Signature Date
Hopper
Ink reservoir
Feed Disc
Metal Disc
Disc Nut
Gravure Roll
Lower Offset Roll
Upper Offset Roll
Air Nozzles
Air Ejector Nozzle

 

  • Conclusions / Comments:
  • PASS                                    FAIL
  • Checked By: ________________________                       Date:   ______________
  • Verified By:   ________________________                       Date:   ______________
  •  Installation Qualification Tests Status
  • The table below lists the tests performed and related results.
Test Number

 

Critical Feature

 

Pass Fail Deviation Found
Yes No
1 Documents & Drawings Verification
2 Verification of Technical Specification for In-House & Sub-contract / bought out items.
3 Utilities Verification
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
  • Prepared by                                           Reviewed By                                    Approved by

 

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