Verification Protocol of Topserter II machine
This article contains information about Performance Verification protocol for Topserter II machine
Performance Verification protocol for Topserter II machine
Objective:
To validate the operation of Topserter II machine, for affixing the Enclosure / Leaflet / Pack insert on top of the cap of the container.
Scope for Performance Verification protocol of Topserter II machine :
Applicable for Topserter II machine.
Justification for selection of item / equipment/ process/ product /system:
Justification for selection of item / equipment/ process/ product /system should be recorded in study report.
Site of the study:
Packing Department
Responsibility:
Packing :
Engineering :
Quality Assurance :
Standard Operating Procedure (SOP) to be followed:
SOP for operating of the Topserter II Machine.
SOP No.: to be recorded in study report.
Control:
Requirements for Performance Verification protocol of Topserter II machine :
- Temperature of the hot melt glue to be maintained.
- All sensors should be kept ‘ON’
- Compressed air Pressure to be maintained.
Calibration:
Calibration details of the instruments/equipments used in the study should be recorded in the study report.
Training:
Trained personnel should perform the study. (Details of training should be recorded in the study report).
Precautions :
All safety aspects must be followed :
Acceptance Criteria for Performance Verification of Topserter II machine :
Refer point (Table I to IV)
Procedure for Performance Verification protocol of Topserter II machine :
Carry out the experiment as per performance verification protocol.
- Record the product details as mentioned below in the study report.
| Product Name : |
| B. No. / Export Order No. (if applicable) : |
| Equipment No. : |
| Date of study : |
| Container Code No. : |
| Cap Code No. : |
| Leaflet / Pack insert / Enclosure Code No. : |
| Glue Length (in mm) : |
Challenge the different sensors and record the observation in study report. (Refer Table No. I)
Check the general test of glue application and pack insert affixing quality by Collecting 10 containers from the top serter II machine during machine run at different speed (Low, High, Optimum speed) and record the observations in study report. (Refer Table No. II, III, IV)
Table I :- Sensors challenge study:-
| Sr. No. | Sensors | Acceptance Criteria |
| 01 | Container check sensor at entry. | Sensor should sense the container at entry for gate. |
| 02 | Container check sensors for glue dispense application. | Sensor should sense the container & glue is dispensed.
|
| 03 | Container placement check sensor for leaflet affix. | Sensor should sense the container & affix the leaflet on the top surface of cap.
|
| 04 | Missing leaflet trigger sensor. | In case of missing leaflet it should reject the container with alarm.
|
| 05 | Container reject verification sensor. | Sensor should sense the rejected container.
|
| 06 | Leaflet minimum load sensor. | Display shows min. level and machine stops automatically.
|
Table II :- Low Speed : No. of Containers per minute.
| Sr. No. | Test | Acceptance Criteria |
| 1 | Glue fire from gun | Glue should get fired Immediately after sensing the container check sensor for glue application. |
| 2 | Glue at center of cap | Glue should be present at the centre of the cap every time. |
| 3 | Glue flow | Glue should not over flow from the cap of the container. |
| 4
|
Glue reproducibility and
its release |
Reproducibility of glue firing on cap of the container and amount of glue release should be uniform. |
| 5 | Vacuum catch | Vacuum catch should catch leaflet / enclosure firmly, should not drop the leaflet / enclosure before affixing. |
| 6
|
Container with missing
leaflet/ pack insert |
Container with missing leaflet / pack insert should be rejected by machine reject control. |
| 7 | Affixing position | Leaflet / Enclosure should affix at the Centre of the cap of the container in synchronous manner. |
Table III :- High Speed : No. of Containers per minute.
| Sr. No. | Test | Acceptance Criteria |
| 1 | Glue fire from gun | Glue should get fired Immediately after sensing the container check sensor for glue application. |
| 2 | Glue at center of cap | Glue should be present at the centre of the cap every time. |
| 3 | Glue flow | Glue should not over flow from the cap of the container. |
| 4
|
Glue reproducibility and
its release |
Reproducibility of glue firing on cap of the container and amount of glue release should be uniform. |
| 5 | Vacuum catch | Vacuum catch should catch leaflet / enclosure firmly, should not drop the leaflet / enclosure before affixing. |
| 6
|
Container with missing
leaflet/ pack insert |
Container with missing leaflet / pack insert should be rejected by machine reject control. |
| 7 | Affixing position | Leaflet / Enclosure should affix at the Centre of the cap of the container in synchronous manner. |
Table IV :- Optimum Speed : No. of Containers per minute.
| Sr. No. | Test | Acceptance Criteria |
| 1 | Glue fire from gun | Glue should get fired Immediately after sensing the container check sensor for glue application. |
| 2 | Glue at center of cap | Glue should be present at the centre of the cap every time. |
| 3 | Glue flow | Glue should not over flow from the cap of the container. |
| 4
|
Glue reproducibility and
its release |
Reproducibility of glue firing on cap of the container and amount of glue release should be uniform. |
| 5 | Vacuum catch | Vacuum catch should catch leaflet / enclosure firmly, should not drop the leaflet / enclosure before affixing. |
| 6
|
Container with missing
leaflet/ pack insert |
Container with missing leaflet / pack insert should be rejected by machine reject control. |
| 7 | Affixing position | Leaflet / Enclosure should affix at the Centre of the cap of the container in synchronous manner. |
Details of Non Compliance: (Deviation / Out Of Specification) :
Details of Deviations (including justification of acceptance if any ) to
successfully carry out the study exercise and Out Of Specification results
obtained should be checked.(attach the details in the study report.)
Type of study :
Performance verification study.
Frequency for Performance Verification protocol of Topserter II machine :
- New Equipment: First three batches.
- One exercise every after three years.
Results / Observations for Performance Verification protocol of Topserter II machine :
Based on the study, results/ observations should be recorded in study report.
Summary of the study : (inference)
Summarize the findings of the study report to draw an inference.
Recommendations :
Record the recommendations based on the interpretation of the results In study report.
Team Approval:
The individuals who have performed the study, supervised
the verification, completed the records should approve the study report.
Review :
The Plant Quality Assurance and Plant Head should review the study report.
The report should include any follow-up action if required.
Approved by :
Plant Quality Assurance and Plant Head should finally approve the study report.
Attachments:
Annexure (if any) to be attached with study report. Should be recorded in the study report.
Abbreviations:
SOP : Standard Operating Procedure
OOS : Out Of Specification
Sr. : Serial
No. : Number
