Verification Report of Topserter II machine
This article contains information about Performance Verification Report for Topserter II Machine.
Performance Verification Report 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:
Applicable for Topserter II machine
Justification for selection of item / equipment / process / product / system.
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.: _________
Control:
Requirements:
Temperature of hot melt glue : _____________
All sensors should be ‘ON’ : Checked by _____________
Compressed air pressure :______________
Calibration:
| Sr. No. | Equipment’s / Instruments | Code No. | Calibration Done on | Calibration Due on |
Training:
| Sr. No. | Name of Persons | Training Status | Availability of Report | Checked By |
Precautions:
Acceptance Criteria:
Refer study protocol
Procedure:
- Carry out the experiment as per study protocol .
- Record the product details in the table below
| 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 observations in Table No. I
- Check the general test of glue application and pack insert affixing quality by Collecting 10 containers from the topserter II machine during machine run at different speed (Low, High, Optimum speed) and record the observations in Table No. II, III and IV.
Table I :- Different Sensors challenge study:-
| Sr. No. | Sensors | Observations | Checked
By/Date |
| 01 | Container check sensor at entry. | ||
| 02 | Container check sensor for glue dispense application. | ||
| 03 | Container placement check sensor for leaflet affix. | ||
| 04 | Missing leaflet trigger sensor. | ||
| 05 | Container reject verification sensor. | ||
| 06 | Leaflet minimum load sensor. |
Table II :- Low Speed : ______Containers per minute.
| Sr. No | Test | Observations | Checked
By / Date |
| 1 | Glue fire from gun. | ||
| 2 | Glue at center of cap. | ||
| 3 | Glue flow.
|
||
| 4 | Glue reproducibility and its release. | ||
| 5 | Vacuum catch.
|
||
| 6 | Container with
missing leaflet/ pack insert. |
||
| 7 | Affixing position.
|
Remarks:
Table III :- High Speed : _______Containers per minute.
| Sr. No. | Test | Observations | Checked
By / Date |
| 1 | Glue fire from gun.
|
|
|
| 2 | Glue at center of cap.
|
|
|
| 3 | Glue flow.
|
|
|
| 4 | Glue reproducibility and its release. |
|
|
| 5 | Vacuum catch.
|
|
|
| 6 | Container with
missing leaflet/ pack insert. |
|
|
| 7 | Affixing position.
|
|
Remarks :
Table IV :- Optimum Speed : ______Containers per minute.
| Sr. No. | Test | Observations | Checked
By / Date |
| 1 | Glue fire from gun. |
|
|
| 2 | Glue at center of cap. |
|
|
| 3 | Glue flow. |
|
|
| 4 | Glue reproducibility and its release. |
|
|
| 5 | Vacuum catch. |
|
|
| 6 | Container with
missing leaflet/ pack insert. |
|
|
| 7 | Affixing position.
|
|
Remarks:
Details of Non Compliance: (Deviation / Out Of Specification)
Details of Deviation (If any):
| Deviation Report Number | Deviation Report Dated | Checked by |
Details of Out of Specification (If any):
| OOS Report Number | OOS Report Dated | Checked by |
Reviewer Comments/remark:
Type of study :
Performance verification study.
Frequency :
- New Equipment: First three batches.
- One exercise after every three years.
Results / Observations:
Summary of the study : (inference)
Recommendations:
Team Approval:
_________ ____________ _______________
Packing Engineering Quality Assurance
Date: Date: Date:
Review (Including follow up action, if any):
Approved by:
__________________ ________________
Plant Quality Assurance Plant Head
Date: Date:
Attachments:
Abbreviations:
SOP : Standard Operating Procedure
OOS : Out Of Specification
Sr. : Serial
No. : Number
