IQ of Blister Packing Machine (BQS)
TABLE OF CONTENT of IQ of Blister Packing Machine (BQS)
- Purpose
- Scope
- Responsibilities
- Procedure
- Installation Qualification tests
- Documents & Drawings Verification
- Verification of Technical Specification for In-House & sub-components / Bought out items
- Utilities Verification
- Material of Construction Verification
- Critical Instrument Calibration Verification
- Installation Qualification Tests Status
- Data Analysis, Summary of IQ & Recommendations
- Amendment Record
- Conclusion
- PURPOSE
To describe the Installation Qualification procedure to be used during qualification of Blister Packing Machine (BQS), 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 equipment will be installed in accordance with Good manufacturing Practices.
- SCOPE
This procedure applies to the installation qualification of Blister Packing Machine (BQS) and its accessories to be installed.
- 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 PAM-PAC Blister Packing Machine (BQS), 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 |
| Documents & Drawings Verification | |
| Verification of Technical Specification for In-House & sub-components / bought out items | |
| Utilities Verification | |
| Material of construction verification | |
| 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 as per below table.
- Review the documents and drawings for completeness and exactness with the installed units.
- Attach the copies of the drawings to this protocol 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 |
- 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 (BQS), 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 (BQS), 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 | BQS | ||||||
| Type | Thermoforming Blister Packing Machine | ||||||
| Dimension | 4500L X 1900W X 2000H | ||||||
| Output | 45 Cycles/min. for PVC/ALU forming 35 Cycles/min. for ALU/ALU forming 200 cycles / min. in punching station. | ||||||
| Forming area | 240 x 180 mm Max. Draw depth 12 mm Max. Draw of Length 180 mm. | ||||||
| Max. Roll Diameter (Forming Film) | 450 mm x 252 mm width 74 – 76 mm core dia. | ||||||
| Max. Roll Diameter (Lidding Foil) | 250 mm x 246 mm width 74 – 76 mm core dia. | ||||||
| Part A = Bought out items | |||||||
| 2. Heating plate bottom | |||||||
| Plate Dimension | 265 x 368 mm | ||||||
| Treatment | Teflon coating | ||||||
| Thermocouple | To be provided | ||||||
| Heater type | Embedded type | ||||||
| Location | Heating station | ||||||
| 3. Pneumatic Cylinder | |||||||
| Make | Festo | ||||||
| Model | ADVUP-40-P-A-25Z1-30Z2 | ||||||
| P max | 10 bar | ||||||
| Location | Bottom Heating Plate | ||||||
| 4. Heating plate top | |||||||
| Plate Dimension | 265 x 368 mm | ||||||
| Treatment | Teflon coating | ||||||
| Thermocouple | To be provided | ||||||
| Heater type | Embedded type | ||||||
| Location | Heating station | ||||||
| 5. Pneumatic Cylinder | |||||||
| Make | Festo | ||||||
| Model | ADVC – 32- 25 – I-P-A 188206T108 | ||||||
| P max | 10 bar | ||||||
| Location | Top Heating Plate | ||||||
| 6. Flow switch | |||||||
| Make | IFM | ||||||
| Model | SI1000 SID10ADBF PKG/US | ||||||
| 7. Top plate | |||||||
| Plate Dimension | 235 x 181 mm | ||||||
| Location | Forming station | ||||||
| 8. Water Condensation Valve | |||||||
| Make | Saimag | ||||||
| Type | Diaphragm | ||||||
| Model | DT-04 | ||||||
| Size | 1½” | ||||||
| 9. Bottom plate | |||||||
| Plate Dimension | 235 x 181 mm | ||||||
| Location | Forming station | ||||||
| 10. Hopper | |||||||
| MOC | Stainless Steel 316 | ||||||
| View Glass | To be provided | ||||||
| Capacity | 50 Ltrs. | ||||||
| Location | Feeding | ||||||
| 11. Level Sensor | |||||||
| Type | Proximity | ||||||
| Location | Rotary Vibrator | ||||||
| Make | IFM | ||||||
| Rating | 250 ma, 36 V DC | ||||||
| 12. Linear vibrator | |||||||
| MOC | Stainless Steel 316 | ||||||
| Location | Feeding | ||||||
| 13. Distributor plate | |||||||
| MOC | Stainless Steel 316 | ||||||
| Location | Feeding | ||||||
| 14. Top plate | |||||||
| Plate Dimension | 185 x 255 mm | ||||||
| Thermocouple | To be provided | ||||||
| Location | Sealing station | ||||||
| 15. Pneumatic Cylinder | |||||||
| Make | Festo | ||||||
| Model | ADVC-40-25-I-P-A 188236T108 | ||||||
| Pmax | 10 bar | ||||||
| Location | Top sealing plate | ||||||
| 16. Locking Cylinder | |||||||
| Qty. | 02 Nos. | ||||||
| Make | Festo | ||||||
| Model | ADVU-25-50-A-P-A 156615T123 | ||||||
| Pmax | 10 bar | ||||||
| Location | Top sealing plate | ||||||
| 17. Bottom plate | |||||||
| Plate Dimension | 280 x 178 mm | ||||||
| Location | Sealing station | ||||||
| 18. Exhaust Fan | |||||||
| Model | REC22038 AL | ||||||
| Power Rating | 220 V, 50 Hz, 1 Amp. | ||||||
| Make | Rexnord | ||||||
| Location | Sealing Station | ||||||
| 19. Emergency Switch | |||||||
| Location | Punching and Perforation | ||||||
| 20. Hydraulic Cylinder | |||||||
| Sr.No. | |||||||
| Type | FFCB4 | ||||||
| Pmax | 160 kg / cm2 | ||||||
| Make | Indian pneumatic and hydraulic co. | ||||||
| Location | Bottom Sealing Plate | ||||||
| 21. Bracket | |||||||
| Material | LM 16 | ||||||
| Hardness | 90-100 BHN | ||||||
| Treatment | GBB | ||||||
| Quantity | 1 No. | ||||||
| Location | Cooling station | ||||||
| 22. Top Plate | |||||||
| Material | H9 T6 | ||||||
| Treatment | GBB | ||||||
| Quantity | 1.No. | ||||||
| Location | Cooling station | ||||||
| 23. Bottom Plate | |||||||
| Material | H9 T6 | ||||||
| Treatment | GBB | ||||||
| Quantity | 1 No. | ||||||
| Location | Cooling station | ||||||
| 24. Pneumatic cylinder | |||||||
| Make | Festo | ||||||
| Model | ADVU-63-5-P-A 156007T123 | ||||||
| Pmax | 10 bar | ||||||
| Location | Bottom cooling plate | ||||||
| 25. Door limit Switches | |||||||
| Qty. | 06 Nos. | ||||||
| Model | XCJ-110 | ||||||
| Make | Telemecanique | ||||||
| Rating | 10 A, 240 V AC | ||||||
| Location | Heating station / Forming station / Sealing station / Cooling station / Perforation and punching station / Material pickup | ||||||
| 26. Pulling disc (Front) | |||||||
| Material | HCHCr | ||||||
| Hardness | 45-50 HRC | ||||||
| Treatment | Blackodising | ||||||
| Location | Pulling station | ||||||
| 27. Pulling disc (Rear) | |||||||
| Material | HCHCr | ||||||
| Hardness | 45-50 HRC | ||||||
| Treatment | Blackodising | ||||||
| Location | Pulling station | ||||||
| 28. Cutting plate (Part of change part ) | |||||||
| Material | HCHCr | ||||||
| Hardness | 58-60 HRC | ||||||
| Treatment | Blackodising | ||||||
| Location | Cutting station | ||||||
| 29. Punch (Part of change part ) | |||||||
| Material | HCHCr | ||||||
| Hardness | 58-60 HRC | ||||||
| Treatment | Blackodising | ||||||
| Location | Cutting station | ||||||
| 30. Good bad sorting chute | |||||||
| MOC | Stainless Steel 304 | ||||||
| Location | Blister sorting station | ||||||
| 31. Suction wheel | |||||||
| Material | Nylon | ||||||
| Location | Blister pick up station | ||||||
| Description | Specification | Meets Spec. (Yes/No) | Verification Source | Initials | Date | |||||||
| Part B = Bought out items | ||||||||||||
| 1. PVC Unwinding motor | ||||||||||||
| Make | Technocraft | |||||||||||
| Rating | 0.15 HP | |||||||||||
| RPM | 1400 RPM | |||||||||||
| Voltage | 415 V | |||||||||||
| Phase | 3 phase | |||||||||||
| Location | PVC Unwinding station | |||||||||||
| 2. Limit Switch | ||||||||||||
| Make | Telemacanique | |||||||||||
| Model | XCJ-127 | |||||||||||
| Rating | 10A 240V AC | |||||||||||
| Location | Near PVC unwinder | |||||||||||
| 3. Rubber ring | ||||||||||||
| Material | Silicon Rubber | |||||||||||
| Size | 50 X 5 | |||||||||||
| Location | PVC Unwinding station | |||||||||||
| 4. Joint detection sensor | ||||||||||||
| Make | Data Logic sensor | |||||||||||
| Model | TL U11 | |||||||||||
| Location | Splicing station | |||||||||||
| 5. Sensor for dancing lever | ||||||||||||
| Type | Inductive | |||||||||||
| Quantity | 04 | |||||||||||
| Model | EGT12X02APO2 45000L | |||||||||||
| Make | Tekeniceuchner | |||||||||||
| Location | PVC unwinding station (02 Nos.) Aluminium Foil unwinding station. (02 Nos.) | |||||||||||
| 6. Heating Coil | ||||||||||||
| Make | Saket | |||||||||||
| Rating | 2.5 KW | |||||||||||
| Location | Heating station | |||||||||||
| Description | Specification | Meets Spec. (Yes/No) | Verification Source | Initials | Date | |||||||
| 7. Power Pack | ||||||||||||
| Make | Zeon | |||||||||||
| Working pressure | 160 Bar | |||||||||||
| 8. Power Pack motor | ||||||||||||
| Type | 3 Phase induction | |||||||||||
| make | Crompton Greaves | |||||||||||
| Motor Rating | 5 HP | |||||||||||
| Sr. No. | ||||||||||||
| Voltage | 415 V AC | |||||||||||
| RPM | 1430 RPM | |||||||||||
| Location | Heating Station | |||||||||||
| 9. Vibrator controller (Linear) | ||||||||||||
| Make | Sai control | |||||||||||
| Voltage | 230 V | |||||||||||
| Rating | 3 A | |||||||||||
| Location | Control Panel | |||||||||||
| 10. Vibrator controller (Rotary) | ||||||||||||
| Make | Sai control | |||||||||||
| Voltage | 230 V | |||||||||||
| Rating | 3 A | |||||||||||
| Location | Control Panel | |||||||||||
| 11. Servo motor | ||||||||||||
| Make | B & R Automation | |||||||||||
| Rating | In 0.70A Mn 0.6 Nm Io 0.73A Mo 0.6 Nm | |||||||||||
| Sr. No. | ||||||||||||
| Location | Drum feeder | |||||||||||
| 12. Motor for Al. Unwinding | ||||||||||||
| Make | Bharat Bijlee | |||||||||||
| Rating | 0.25 HP | |||||||||||
| RPM | 1350 RPM | |||||||||||
| Description | Specification | Meets Spec. (Yes/No) | Verification Source | Initials | Date | |||||||
| Voltage | 415 V AC | |||||||||||
| Phase | 3 Phase | |||||||||||
| Location | Al. Unwinding station | |||||||||||
| 13. Proximity Switch | ||||||||||||
| Qty. | 05 Nos. | |||||||||||
| Make | Tekniceuchener | |||||||||||
| Model | EGT 18 X 05 AP024-5000 L | |||||||||||
| Location | Near Al. Unwinding Station / Perforation and punching / Drum feeder / Servo main motor / Pickup station | |||||||||||
| 14. Proximity Switch | ||||||||||||
| Qty. | 02 Nos. | |||||||||||
| Make | Telco | |||||||||||
| Model | SMP8500PG2.5 | |||||||||||
| Location | Blister Discharge | |||||||||||
| 15. Air Gun | ||||||||||||
| Make | Festo | |||||||||||
| Model | LBP – ¼ 3552858 | |||||||||||
| Pmax | 10 bar | |||||||||||
| 16. Ink cartridge | ||||||||||||
| Make | Process instrumentation and control | |||||||||||
| Size | Dia.50 X 245 Lg. | |||||||||||
| location | Overprinting Station | |||||||||||
| Description | Specification | Meets Spec. (Yes/No) | Verification Source | Initials | Date | |||||||
| 17. Ink | ||||||||||||
| Make | Dolphin Ink (I) | |||||||||||
| Specification | DIPL 39 | |||||||||||
| Mixture | 60% with thinner | |||||||||||
| location | Overprinting Station | |||||||||||
| 18. Thinner | ||||||||||||
| Make | Dolphin Ink (I) | |||||||||||
| Specification | DIPL 20 | |||||||||||
| Mixture | 40% with ink | |||||||||||
| Location | Overprinting station | |||||||||||
| 19. Gear Box | ||||||||||||
| Type | VF-44-PMS | |||||||||||
| Make | Bonfiglioli | |||||||||||
| Ratio | 1 : 28 | |||||||||||
| Location | Printing | |||||||||||
| 20. Servo Motor | ||||||||||||
| Sr. No. | ||||||||||||
| Model | 8MSA2L.RO-6 | |||||||||||
| Make | B & R Automation | |||||||||||
| Rating | In 0.70A Mn 0.6 Nm Io 0.73A Mo 0.6 Nm | |||||||||||
| Location | Printing | |||||||||||
| 21. Gear box | ||||||||||||
| Make | Bonfiglioli | |||||||||||
| Ratio | 1:30 | |||||||||||
| Location | Pulling station | |||||||||||
| Description | Specification | Meets Spec. (Yes/No) | Verification Source | Initials | Date | |||||||
| 22. Servo motor | ||||||||||||
| Sr. No. | ||||||||||||
| Model | 8MSA4M.RO-31 | |||||||||||
| Make | B & R Automation | |||||||||||
| Rating | In 3.75A Mn 4.6 Nm Io 4.10A Mo 5.3 Nm | |||||||||||
| Location | Pulling station | |||||||||||
| 23. Gear box | ||||||||||||
| Make | Technocraft | |||||||||||
| Sr. No. | ||||||||||||
| Ratio | 7.5 : 1 | |||||||||||
| Location | Punching and perforation | |||||||||||
| 24. Servo motor | ||||||||||||
| Sr. No. | ||||||||||||
| Model | 8MSA4L.RO-31 | |||||||||||
| Make | B & R Automation | |||||||||||
| Rating | In 4.35A Mn 6.4 Nm Io 4.80A Mo 7.5 Nm | |||||||||||
| Location | Punching and perforation | |||||||||||
| 25. Vacuum pump | ||||||||||||
| Make | Indovac | |||||||||||
| Sr.No. | ||||||||||||
| Model | IV500 | |||||||||||
| Rating | 2 HP, 1440 RPM | |||||||||||
| Capacity | 500 LPM | |||||||||||
| Description | Specification | Meets Spec. (Yes/No) | Verification Source | Initials | Date | |||||||
| Pressure | 26” of Hg. | |||||||||||
| Location | Blister pick up station | |||||||||||
| 27 Suction cup | ||||||||||||
| Make | IWKA | |||||||||||
| Material | Polyurethene | |||||||||||
| Location | Blister pick up station | |||||||||||
| 26. Vacuum pump motor | ||||||||||||
| Make | Bhart Bijlee | |||||||||||
| Sr. No. | ||||||||||||
| Supply voltage | 415 V AC | |||||||||||
| Rating | 2 HP | |||||||||||
| RPM | 1415 RPM | |||||||||||
| Phase | 3 Phase | |||||||||||
| Location | Blister pick up station | |||||||||||
| 27. Main motor | ||||||||||||
| Sr.No. | ||||||||||||
| Model | 8 MSA4L.EO.33 | |||||||||||
| Make | B & R Automation | |||||||||||
| Rating | In 4.35 A Io 4.80A Mn 6.4 Nm Mo 7.5 Nm | |||||||||||
| Location | Main drive | |||||||||||
| 28. Machine mounts | ||||||||||||
| Make | AV Mount | |||||||||||
| Location | Machine structure | |||||||||||
| 29. Gear Box | ||||||||||||
| Make | Bonfiglioli | |||||||||||
| Ratio | 1:30 | |||||||||||
| Location | Main drive | |||||||||||
| Description | Specification | MeetsSpec. (Yes/No) | Verification Source | Initials | Date | |||||||
| 30. PRC Scanner | ||||||||||||
| Make | Data logic | |||||||||||
| Model | TL 10 | |||||||||||
| Specification | PNP / 24 V DC | |||||||||||
| Location | Print Registration | |||||||||||
| 31. MMI | ||||||||||||
| Make | B & R Automation | |||||||||||
| Type | 4 D 1170 Touch screen | |||||||||||
| Location | Moveable | |||||||||||
| 32. PLC | ||||||||||||
| Make | B & R Automation | |||||||||||
| Type | C 221 | |||||||||||
| Rating | 4 I/O cards & 1 relay card | |||||||||||
| Location | Electronic control | |||||||||||
| 33. AC Drive (Main Motor) | ||||||||||||
| Make | B & R Automation | |||||||||||
| Model | ACOPOS 1090 | |||||||||||
| Location | Electronic control | |||||||||||
| 34. AC Drive (Punching Motor) | ||||||||||||
| Make | B & R Automation | |||||||||||
| Model | ACOPOS 1090 | |||||||||||
| Location | Electronic control | |||||||||||
| 35. AC Drive (Pulling Motor) | ||||||||||||
| Make | B & R Automation | |||||||||||
| Model | ACOPOS 1045 | |||||||||||
| Location | Electronic control | |||||||||||
| Description | Specification | Meets Spec. (Yes/No) | Verification Source | Initials | Date | |||||||
| 36. AC Drive (Feeding Motor) | ||||||||||||
| Make | B & R Automation | |||||||||||
| Model | ACOPOS 1022 | |||||||||||
| Location | Electronic control | |||||||||||
| 37. AC Drive (Overprinting Motor) | ||||||||||||
| Make | B & R Automation | |||||||||||
| Model | ACOPOS 1022 | |||||||||||
| Location | Electronic control | |||||||||||
- Equipment Number Identification
| Equipment Name | Sr.No. | Equipment no. | Checked By | Date |
| 1.PVC Unwinding motor | ||||
| 02 Motor for Al. Unwinding | ||||
| 03. Servo motor ( pulling station) | ||||
| 04. Servo motor (Punching and perforation) | ||||
| 05. Main motor (Main drive) |
- 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 provide |
- Material of Construction Verification
- Rationale –
To verify that all assembly of PAM-PAC Blister Packing Machine (BQS), 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 |
| Main frame | M. S. | ||||
| Cladding | Stainless Steel 304 | ||||
| Hopper | Stainless Steel 316 | ||||
| Linear vibrator | Stainless Steel 316 | ||||
| Distributor plate | Stainless Steel 316 | ||||
| Feeding sector | Al. Anodized | ||||
| Feeding Channel | Al. Anodized | ||||
| Good Bad Sorting Chute | SS 304 |
- Critical Instrument Calibration Verification
- Rationale –
To verify that all critical instruments for the PAM-PAC Blister Packing Machine (BQS), 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 to this protocol.
- Acceptance Criteria
- All critical instrumentation for the PAM-PAC Blister Packing Machine (BQS), shall be in a state of calibration.
- Instrumentation List Results
| Description | Manufacturer | Model | Serial # | Set point Operating Range | Current Calibration | |
| Yes/ No | Sign / Date | |||||
| Temperature sensor (Inlet water temp.) | ||||||
| Vibrator controller (Linear vibrator) | ||||||
| Vibrator controller (Rotary vibrator) | ||||||
| Vacuum gauge | ||||||
| Pressure gauge | ||||||
| Temperature controller (Heating plate top) | ||||||
| Temperature controller (Heating plate bottom) | ||||||
| Temperature controller (Sealing station) | ||||||
| Temperature controller (forming station) | ||||||
- 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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