- Installation qualification of Blister Packing Machine (Hoonga)
- PURPOSE
- To describe the Installation Qualification procedure to be used during qualification of Blister Packing Machine (Hoonga), its accessories and to define the Specification of the system in order to
- Ensure that the equipment meets the specification as 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 Good manufacturing Practices.
- SCOPE
- This procedure applies to the installation qualification of Blister Packing Machine (Hoonga).
- RESPONSIBILITIES
- It is the responsibility of the Manufacturer to prepare the installation qualification as per Design Qualification
- It is the responsibility of the client to check and approve the installation qualification.
- 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 PAM-PAC Blister Packing Machine (Hoonga), 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 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 |
| 5.5 | 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 in the table 5.1.5 is available.
- Review the documents and drawings for completeness and exactness with the installed units.
- Attach the copies of the drawings 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.
| S.No | Description | Document No | Verified By | 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 PAM-PAC Blister Packing Machine (Hoonga), 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 PAM-PAC Blister Packing Machine (Hoonga), is 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.
- Components Result
| Description | Specification | Meets
Spec. (Yes/No) |
Verification Source | Initials | Date | ||
| 1. Blister Packing Machine | |||||||
| Model | Ministar 03 | ||||||
| Make | Hoonga | ||||||
| Sr. No. | M5M000322 | ||||||
| Power Rating | 440 V / 3 Phase / 50 Hz | ||||||
| Dimension | 5850 (L) mm X 1120 mm (W) X 1825 (H) mm | ||||||
| A. Forming Station | |||||||
| 1. PVC / ALU Uncoiler Sensor | |||||||
| Make | Sick | ||||||
| Power Rating | 10 – 30 VDC | ||||||
| Sr. No. | 1018048 | ||||||
| 2. PVC / ALU Joint Sensor | |||||||
| Make | Omron | ||||||
| Model | E 3 M – VG 11 | ||||||
| Power Rating | 10 – 30 VDC | ||||||
| 3. PVC / ALU Motor Sensor | |||||||
| Make | Autonics | ||||||
| Model | PF 125 – 8 DN | ||||||
| Power Rating | 10 – 30 VDC | ||||||
| Qty. | 01 Nos. | ||||||
| Location | Uncoiling Station for base film | ||||||
| 4. Pressure Cylinder for Top Forming Plate | |||||||
| Make | Festo | ||||||
| Max. Pressure | 10 bar | ||||||
| Model | 15039001 | ||||||
| Type | U 433 | ||||||
| 5. Lower Platen Up Cylinder | |||||||
| Make | Festo | ||||||
| Max. Pressure | 10 bar | ||||||
| Model | |||||||
| Type | |||||||
| 6. Pressure Switch | |||||||
| Make | Festo | ||||||
| Model | PEVK-178 | ||||||
| Part No. | 276045 | ||||||
| Range | 2-6 bar | ||||||
| B. Feeding Unit | |||||||
| 1. Spring Acting Pressure Cylinder | |||||||
| Make | Festo | ||||||
| Max. Pressure | 10 bar | ||||||
| Model | 188223 | ||||||
| Type | U 408 | ||||||
| 2. Product Sensor | |||||||
| Make | Omron | ||||||
| Model | E3S – AT61 – L | ||||||
| Power Rating | 10 – 30 VDC | ||||||
| 3. Product Sensor | |||||||
| Make | Omron | ||||||
| Model | E3S – AT61 – D | ||||||
| Power Rating | 10 – 30 VDC | ||||||
| 4. Feeding Cylinder | |||||||
| Make | Festo | ||||||
| Max. Pressure | 10 bar | ||||||
| Model | 193990 | ||||||
| Type | U 433 | ||||||
| 7. Feeding | |||||||
| Top Feeding channel | |||||||
| Shuttler | |||||||
| Spring | |||||||
| 8. Hopper | |||||||
| Capacity | |||||||
| Dimensions | 410 mm (H) X 455 mm (D) | ||||||
| Hopper Covering Lid | To be Provided | ||||||
| View Glasses | 02 Nos. | ||||||
| 5. Vibrator Motor | |||||||
| Type | |||||||
| Model | |||||||
| Make | |||||||
| Sr. No. | |||||||
| Power Rating | |||||||
| RPM | |||||||
| 6. Feeding Motor | |||||||
| Type | |||||||
| Model | |||||||
| Make | |||||||
| Sr. No. | |||||||
| Power Rating | |||||||
| RPM | |||||||
| 7. V – Belt | |||||||
| Make | Dungil | ||||||
| Type | M -19.5 | ||||||
| 8. Peddle | |||||||
| MOC | Silicon Rubber | ||||||
| 9. Control Panel | |||||||
| Chute Vibrator ON / OFF knob | 01 No. | ||||||
| Feeding Roller ON / OFF knob | 01 No. | ||||||
| Speed Controller | For Chute Vibrator and Feeding Roller | ||||||
| Speed Controller Range | 0-100 | ||||||
| C. Sealing Station | |||||||
| 1. Print Registration Control ( PRC) Sensor | |||||||
| Make | Sick | ||||||
| Sr. No. | 1018045 | ||||||
| Power Rating | 10-30 VDC | ||||||
| 2. Print Registration Control ( PRC) Correction Cylinder | |||||||
| Make | Festo | ||||||
| Model | ADV – 20 – 15 – P – A | ||||||
| Max. Pressure | 10 bar | ||||||
| Location | Below Draw of assembly | ||||||
| 3. Pressure Cylinder For Top Sealing station | |||||||
| Make | Festo | ||||||
| Model | ADV – 50 – 30 – P – A | ||||||
| Type | 150 353 49 U 433 | ||||||
| Max. Pressure | 10 bar | ||||||
| Location | Below Draw of assembly | ||||||
| 9. Pressure Cylinder (Locking) | |||||||
| Make | Festo | ||||||
| Model | ADV – 50 – 30 – P – A | ||||||
| Type | 15035335 U 433 | ||||||
| Max. Pressure | 10 bar | ||||||
| 4. Tare Punching Assembly | |||||||
| Make | Festo | ||||||
| Model | AVL – 20 – 10 | ||||||
| Pmax | 10 bar | ||||||
| Qty. | 05 Nos. | ||||||
| 5. Pressure cylinder (Embosing Station) | |||||||
| Make | Festo | ||||||
| Type | 150 33 47 U 433 | ||||||
| Pmax. | 10 bar | ||||||
| 6. Waste coiler dancing arm sensor | |||||||
| Model | PF 125 – 8 DN | ||||||
| Power Rating | 10-30 VDC | ||||||
| Make | Autonics | ||||||
| Qty. | 02 Nos. | ||||||
| D. Second Conveyor | |||||||
| 1. Speed Controller | |||||||
| Output Power | 180 W | ||||||
| Power Rating | 1 Ph, 220 V, 60 Hz | ||||||
| Current | 1.38 A | ||||||
| Make | SPG Co. Ltd. | ||||||
| Capacity | 7.0 M.F. | ||||||
| 2. Timing Belt | |||||||
| Belt No. | 203 L | ||||||
| Make | Breco Power | ||||||
| E. Main Control Panel | |||||||
| 1. Temp. Controller for U/L sealing plate | |||||||
| Make | Autonics | ||||||
| Model | T24ST | ||||||
| Range | 0- 0C | ||||||
| 2. Temp. Controller (Sealing) | |||||||
| Make | Autonics | ||||||
| Model | T24ST | ||||||
| Range | 0- 0C | ||||||
| 3. Temp. Controller (Slitler) | |||||||
| Make | Autonics | ||||||
| Model | T24ST | ||||||
| Range | 0- 0C | ||||||
| 4. Control Panel | |||||||
| Power ON / OFF Lock | 01 No. | ||||||
| Reset Push Button | 01 No. | ||||||
| Start / Stop Push Button | 01 No. | ||||||
| Speed Controller | Range : 0-90
Least Count : 2 |
||||||
| Emergency Push Button | 01 No. | ||||||
| Preheater (U/L) Plate Temp. Controller | 01 No. Each | ||||||
| Sealing Temp. Controller | 01 No. | ||||||
| Slitler Temp. controller | 01 No. | ||||||
| 5. Control Panel for the Start Stop | |||||||
| Emergency Start / Stop | 01 No. | ||||||
| 6. Inching Jack | |||||||
| Make | Koino | ||||||
| Model | KH – 701 | ||||||
| Power Rating | 380 VAC / 5A | ||||||
| ON / OFF Switch | 01 No. Each | ||||||
| 7. MMI | |||||||
| Make | Weintek Labs | ||||||
| Sr. No. | 06040793 | ||||||
| Model | MT508TV | ||||||
| Power Rating | 24 VDC | ||||||
| Operating Temp. / Humidity | 0-450C / 10-90 % | ||||||
| PC | RS – 232 | ||||||
| PLC | RS – 485 | ||||||
| Printer Port | Present | ||||||
| 8. Main Motor | |||||||
| Make | GTR | ||||||
| Type | 3 Phase Induction Motor | ||||||
| Sr. No. | 62544353001 | ||||||
| Power Rating | 1.5 KW / 4 Pole
50 Hz / 380 V / 1430 RPM 50 Hz / 400 V / 1440 RPM 60 Hz / 420 V / 1730 RPM 60 Hz / 440 V / 1740 RPM |
||||||
| Reaction Rate | 30:1 | ||||||
| 9. Noise Filter | |||||||
| Make | Samil | ||||||
| Model | NF2 – 4040SG | ||||||
| Power Rating | 450 VAC / 40 A | ||||||
| Temp. | -250C to 850C | ||||||
| LOT No. | 6C 07 | ||||||
| 10. Transformer | |||||||
| Make | Woonyoung | ||||||
| Model | Au – 7.5 KDW | ||||||
| Power Rating | 7.5 KW 50-60 Hz | ||||||
| 11. Gear Box | |||||||
| Make | ESG | ||||||
| Type | ES4AI | ||||||
| Power Rating | 5 – 6.1 KW | ||||||
| Input RPM | 1750 | ||||||
| Mfg. No. | 0064 | ||||||
| 12. Timing Belt | |||||||
| Make | Breco – Power | ||||||
| Type | 304 L | ||||||
| Qty. | 01 No. | ||||||
| 13. Timing Belt | |||||||
| Make | Breco – Power | ||||||
| Type | 270 L | ||||||
| Qty. | 01 No. | ||||||
| 14. VFD | |||||||
| Make | Telemecanique | ||||||
| Model | ATV31HU15N4A | ||||||
| Power Rating | 1.5 KW / 2 HP | ||||||
| Sr. No. | 080538004027 | ||||||
| 15. PLC | |||||||
| Make | Omron | ||||||
| Model | PS4SMAC CJIMCPU23 | ||||||
| F. Chiller | |||||||
| 1. Temp. Controller Knob | |||||||
| Range | -300C to +300C | ||||||
| Least Count | |||||||
| 2. Pressure Gauge | |||||||
| Make | Rashope | ||||||
| Range | 0-15 Kg / cm2 | ||||||
| Least Count | 0.6 Kg / cm2 | ||||||
| 3. Conveyor UP / DOWN cylinder / Conveyor | |||||||
| Make | Festo | ||||||
| Model | 15061589 | ||||||
| Type | T 833 | ||||||
| 4. Sucker UP/ DOWN Cylinder / Punching Tool | |||||||
| Make | Festo | ||||||
| Model | 156205 (U 433) | ||||||
| Pmax. | 10 bar | ||||||
| 5. Compressor | |||||||
| Make | ACC | ||||||
| Model | R22 | ||||||
| Sr. No. | 10052 | ||||||
| Motor(Water) | |||||||
| Power Rating | 30 W / 220 V | ||||||
| Sr. No. (PM) | 030 PM | ||||||
| 6. Pressure cylinder (Draw off) | |||||||
| Make | Festo | ||||||
| Sr. No. | 188210T508 | ||||||
| Model | ADVC – 32 – 10 – I – P | ||||||
| Pmax. | 10 bar | ||||||
| Qty. | 02 Nos. | ||||||
| 7. Solinoid Valve with vacuum Generator | |||||||
| Make | Festo | ||||||
| Power Rating | 24 VDC / 50-60 Hz | ||||||
| Type | MFH – 3-14 9964U202 | ||||||
| Capacity | 1.5 – 8 bar | ||||||
| 8. Vacuum Generator | |||||||
| Make | V tec | ||||||
| 9. FRL Unit | |||||||
| Make | Festo | ||||||
| Pmax | 16 bar | ||||||
| Sr. No. | 159590 T 443 | ||||||
| 10. Pressure Gauge | |||||||
| Make | Festo | ||||||
| Range | 0-16 bar | ||||||
| Least Count | 0.1 bar | ||||||
| Sr. No. | 356759T2 | ||||||
- Equipment Number Identification
| Equipment Name | Service | Equipment no.
(If applicable) |
Checked By | Date |
| 1. Pressure Gauge | Main air pressure | |||
| 2. Pressure Gauge | Pick up | |||
| 3. Pressure Gauge | Flap for Alu / Alu | |||
| 4. Pressure Gauge | Cutting Rejection | |||
| 5. Pressure Gauge | Cooling Plate | |||
| 6. Pressure Gauge | Sealing Station down (Top Cylinder) | |||
| 7. Pressure Gauge | Sealing Lock | |||
| 8. Pressure Gauge | Foil Brake | |||
| 9. Pressure Gauge | Foil Brake | |||
| 10. Pressure Gauge | Air Reservoir Pressure for forming | |||
| 11. Pressure Gauge | Main cam pressure | |||
| 12. Pressure Gauge | Heating station pneumatic pressure | |||
| 13. Pressure Gauge | Product stopper | |||
| 14. Pressure Gauge | Product stopper | |||
| 15. Pressure Gauge | Main Hydraulic pressure | |||
| 16. Pressure Gauge | Accumulator pressure | |||
| 17. Pressure Gauge | Oil Pressure Gauge | |||
| 18. Vaccum Pressure Gauge | Vaccum Pressure | |||
| 19. Temperature Gauge | Temp. of Hydraulic Oil |
- 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 |
| Electrical connection | To be provided | ||
| Compressed Air connection | To be provided | ||
| Cooling water | To be provided |
Conclusions / Comments:
- Material of Construction Verification
- Rationale – To verify that all assembly of PAM-PAC Blister Packing Machine (Hoonga), has been manufactured as per the specification provided by the customer.
- Test equipment – Moly testing unit (To identify 304 or 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 SS316 & if the solution turns pink and immediately vanishes, then it is SS304.
- Acceptance Criteria:
- All material of construction for the PAM-PAC Blister Packing Machine (BQS), shall meet the MOC provided in Design Qualification.
- Material other than SS316 and SS304 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 | Initials | Date |
| Cladding | Stainless Steel 304 | ||||
| Hopper | Stainless Steel 316 | ||||
| Linear vibrator | Stainless Steel 316 | ||||
| Distributor plate | Stainless Steel 316 | ||||
| Good Bad Sorting Chute | SS 304 |
- Conclusions / Comments:
- Critical Instrument Calibration Verification
- Rationale – To verify that all critical instruments for the PAM-PAC Blister Packing Machine (Hoonga), has been calibrated before starting the Operational Qualification.
- 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.
- Acceptance Criteria – All critical instrumentation for the PAM-PAC Blister Packing Machine (Hoonga), shall be in a state of calibration.
- Instrumentation List Results
| Description | Manufacturer | Model | Serial # | Set point Operating Range | Current
Calibration |
|
| Yes/ No | Sign / Date | |||||
| Pressure Gauge (07 Nos.) | Festo | 345394S4 | 0-16 bar | |||
| Pressure Gauge (02 Nos.) | Festo | 366759R9 | 0-16 bar | |||
| Pressure Gauge (01 No.) | Festo | 345395S1 | 0-16 bar | |||
| Pressure Gauge (04 Nos.) | Festo | 345395S3 | 0-16 bar | |||
| Pressure Gauge (01 No.) | Shreeji | E9932 | 0-280 kg / cm2 | |||
| Pressure Gauge (01 No.) | Shreeji | E9893 | 0-280 kg / cm2 | |||
| Pressure Gauge (01 No.) | fgb | A60527 | 0-21 kg / cm2 | |||
| Vaccum Gauge | A-Make | AL-01 | 0 to -760 mmHg | |||
| Temperature Gauge | Shreeji | 1013-12-04 | 0-100ºC | |||
- Conclusions / Comments:
- Installation Qualification Tests Status
- The table below lists the tests performed and related results.
| Test Number
|
Critical Feature
|
Pass / Fail | Deviation Found | ||
| Pass | Fail | 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 | ||||
| 5.5 | Critical Instrument Calibration Verification | ||||
- Data Analysis, Summary of IQ & Recommendations
- AMENDMENT RECORD
| S. No. | Item Name | Remarks | Signature & Date |
- Note : Any changes made in the system must be recorded in this sheet.
- CONCLUSION
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