| Equipment Name : | Induction Cap Sealing Machine |
| Equipment Model No.: | Sigma – II |
| Equipment Sr. No.: | 213/11/-12 |
| Equipment ID No.: | XYZ |
| Equipment Area : | XYZ |
| Equipment Manufacturer Name : | Electronic Devices, Mumbai |
| Equipment Application : | To seal aluminium foil (sealing wad) retained in head space of cap with lip of HDPE bottles (containing product) online by induction sealing method. |
| Report Date : |
REPORT APPROVAL:
| Prepared by | Checked by | Checked by | Checked by | Approved by | |
| Signature | |||||
| Date | |||||
| Name | |||||
| Department | Production | Head-Production | Quality Assurance | Head -Engineering | Head – Quality Assurance |
- OBJECTIVE:
- Objective is to record the findings of performance qualification (PQ) of Induction Cap Sealing Machine.
2.0 SCOPE:
- The scope of this exercise is limited to Induction Cap Sealing Machine having ID No. XYZ.
3.0 RESPONSIBILITIES:
- Quality Assurance Officer/Executive: To prepare qualification report and co-ordinate the entire qualification activity.
- Quality Assurance Officer/Executive: To witness the qualification study and ascertain that the study is conducted as per the protocol.
- Production Officer/Executive: To execute qualification study in co-ordination with other departments.
- Head Maintenance: To review the qualification documents.
- Head Quality Assurance: To review and approve the qualification protocol and report.
- 4.0 EQUIPMENT DESCRIPTION:
- Refer installation qualification protocol No.: XYZ.
- 5.0 PROCEDURE:
Qualification of the equipment should meet the acceptance criteria outlined in the following steps.
- 5.1 Performance Verification Report:
- 5.1.1 Performance of the equipment shall be verified by simulating the normal operation i.e. sealing of aluminium foil (sealing wad) retained in head space of cap with lip of HDPE bottles (containing product) online. While doing this exercise consideration shall give to the operating range of the equipments i.e. size of bottle (40 cc and 1300 cc bottles), size of cap (33 mm and 53 mm caps) and speed of conveyor.
- 5.1.2 The generated data during performance of equipment are recorded in a following table.
- 5.1.3 Acceptance Criteria:
- 5.1.3.1 There shall be no single bottle found with improper sealing and burned sealing wad and inside surface of cap.
- 5.1.3.2 Leak test shall be negative i.e. tablets, silica gel canister and cotton shall not be moistened.
5.1.1 Observations of sealing of 33mm Caps on 40cc HDPE bottles at different speed
| Product Name | |
| Bottle Size | |
| Cap type | |
| Cap size | |
| Distance between coil and Cap surface |
| Sr. No | Speed of Conveyor | Set Power Level Range in % | Actual Power Level in % | Observations of Sealing Quality | Observations of Burned Wad | Observations of Leak test | Checked by sign/date |
| 1.0 | 20 Hertz | 92-98% |
| Sr. No | Speed of Conveyor | Set Power Level Range in % | Actual Power Level in % | Observations of Sealing Quality | Observations of Burned Wad | Observations of Leak test | Checked by sign/date |
| 2.0 | 30 Hertz | 92-98% |
| Sr. No | Speed of Conveyor | Set Power Level Range in % | Actual Power Level in % | Observations Sealing Quality | Observations Burned Wad | Observations of Leak test | Checked by sign/date |
| 3.0 | 40 Hertz | 92-98% |
5.1.2 Challenge test report
| Sr. No. | Simulation Operation | Acceptance Criteria | Observations | Checked by Sign/Date |
| 1.0 | Foil (sealing wad) missing cap bottle detect sensor challenge test | Message ‘No Foil’ shall appear on LCD screen.Red colour lamp shall glow on.Buzzer shall off.Reject cylinder shall reject foil (sealing wad) missing cap bottle online. |
Remarks / Comments:
5.1.3 Observations of sealing of 53mm Caps on 1300cc HDPE bottles at different speed
| Product Name |
| Bottle Size |
| Cap type |
| Cap size |
| Distance between coil and Cap surface |
| Sr. No | Speed of Conveyor | Set Power Level Range in % | Actual Power Level in % | Observations of Sealing Quality | Observations of Burned Wad | Observations of Leak test | Checked by sign/date |
| 1.0 | 20 Hertz | 60-70% |
| Sr. No | Speed of Conveyor | Set Power Level Range in % | Actual Power Level in % | Observations of Sealing Quality | Observations of Burned Wad | Observations of Leak test | Checked by sign/date |
| 2.0 | 30 Hertz | 70-80% |
| Sr. No | Speed of Conveyor | Set Power Level Range in % | Actual Power Level in % | Observations of Sealing Quality | Observations of Burned Wad | Observations of Leak test | Checked by sign/date |
| 3.0 | 40 Hertz | 92-98% |
5.1.4 Challenge test report
| Sr. No. | Simulation Operation | Acceptance Criteria | Observations | Checked by Sign/Date |
| 1.0 | Foil (sealing wad) missing cap bottle detect sensor challenge test | Message ‘No Foil’ shall appear on LCD screen.Red colour lamp shall glow on.Buzzer shall off.Reject cylinder shall reject foil (sealing wad) missing cap bottle online. |
Remarks / Comments:
5.0 DEVIATION REPORT:
| Sr. No. | Deviation (s) | Justification for acceptance criteria | Impact on installation, operation and performance |
- 6.0 CHANGE CONTROL:
- 7.0 LIST OF ANNEXURE:
8.0 SUMMARY AND CONCLUSION OF PERFORMANCE QUALIFICATION:
9.0 CERTIFICATION OF PERFORMANCE QUALIFICATION:
Performance Qualification is satisfactory. Yes/No
Hence equipment can be used for routine use. Yes/No
Head- Q.A.
For PQ Protocol can Refer https://pharmaceuticalupdates.com/2021/07/07/induction-cap-sealing-machine-performance-qualification-protocol/
Pharmaceutical Updates 