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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