Verification protocol for Packing on Cartonator
This article contains information about Performance Verification protocol for Packing on Cartonator
Performance Verification protocol for Packing on Cartonator
Objective:
To ensure that the cartonator is functioning as it is supposed to sense number of unit / pack / container, carton and leaflet, proper closing of carton flap (front and rear), embossing or printing on carton flap.
Scope:
Applicable to all products packed on cartonator.
Principle:
Works on :
- No unit / pack or container : carton as well as leaflet will not get sucked resulting in empty cycle.
- No carton / leaflet : display shows minimum load resulting in empty cycle.
- Excess unit pack : resulting machine stoppage with product feeler control.
Justification for selection of item / process / product (formula) /storage condition:
Justification for selection should be recorded in the report.
Site of Study:
Pharma Packing
Responsibility:
Representative from
Production
Quality Assurance
Engineering
Description of the Equipment to be used:
Equipment : Cartonator ·
CODE No : Details to be recorded in the report.
- Date of Equipment Qualification done is to be recorded in the report.
Standard Operating Procedure (SOP) to be followed:
SOP for operating cartonator :
Reference SOP Number to be recorded in the report.
Control:
Requirements:
- SOP for operating Cartonator (SOP No. to be recorded in the report )
- Vacuum pressure should be between 4 to 6 bar.
Training
Trained personnel details to be recorded in the report.
Calibration
Calibration details to be recorded in the report.
Precautions
Safety aspects during operation of the equipment and processing of the product must be ensured
Validation Procedure:
Operate the Cartonator as per SOP.
Carry out the test as per the following table.
| Sr. No. |
Checks |
Acceptance Criteria |
| 1. | Set the number of blisters to be released from the pack cell. | Only set number of pack / unit should be released in the pack cell. |
| 2. | Repeat the above step two times more and record the observations in the report | Only set number of blisters should be released in the Pack cell. |
| 3. | No blister / container in the pack cell | Carton and leaflet should not be released by the respective sensors. |
| 4. | No leaflet in the leaflet magazine box | Machine stop showing missing leaflet and after restart sensed carton should be rejected in tray due to missing leaflet inside the carton. |
| 5. | Remove the carton after closing of flap, check the quality of carton at the end for proper closing, number of pack / unit and insertion of enclosure | a) Cartons flap (front and rear) should get closed properly
b) Standard number of blister / container and enclosure should be present in the carton |
| 6. | Carton / leaflet loading sensor | Shows minimum level on screen and after 1 minute machine should stop automatically |
| 7. | Check the overprinting / embossing quality of carton | It should be clear, legible and easily identifiable |
| Check the interlocking of following one by one | ||
| 1. | Emergency off | Interlock should be available for these |
| 2. | Guards open | Interlock should be available for these |
| 3. | Handle wheel | Interlock should be available for these |
| 4. | Vacuum pump | Interlock should be available for these |
Acceptance criteria:
Refer above point
Non Compliance:
Details of deviations (including justification of acceptance) done to successfully carry out the validation exercise and any OOS results obtained should be checked. (Attach the details in the Validation report)
Type of validation:
Concurrent Validation:
Frequency:
One Validation exercise per year.
Results:
Record the observations during the study and results obtained from Validation Report.
Summary of findings of experiment (inference):
Summarize the findings of the Validation Study to draw an inference.
Recommendation (Including requirements of any additional documentation):
Record the recommendations based on the interpretation of the results of the Validation Report.
Team approval:
The individuals who have performed the Validation Study, supervised the validation, completed the records, performed the testing of the
product should approve the validation report.
Review (inclusive of follow up action, if any)
The Validation Report should be reviewed by plant Quality Assurance and plant Head. The report should include any follow up action if
required.
Approved by
Validation Report should be finally approved by plant Quality Assurance
and plant Head.
Annexures:
Annexures (if any) attached to the Validation Report should be recorded.
Abbreviations:
OOS : Out of specification
SOP : Standard Operating Procedure
