Verification report for Packing on Cartonator
This article contains information about Performance Verification report for Packing on Cartonator
Performance Verification report 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 packing 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:
Site of Study:
Pharma Packing
Responsibility:
Representative from Production : ____________________________
Quality Assurance : ____________________________
Engineering : ____________________________
Description of the Equipment to be used:
Equipment : Cartonator ·
CODE No : _________________
- Date of Equipment Qualification done _______________
Standard Operating Procedure (SOP) to be followed for Performance Verification of Packing on Cartonator :
SOP for operating cartonator SOP No. : ___________.
Control:
A. Requirement:
SOP for operating Cartonator SOP No________________.
B. Training:
| Name | Training Status | Training Report Availability | Checked by |
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c) Calibration:
| Sr. No. | Equipment | Code No. | Calibration Done on | Calibration Due on |
D) Precaution:
Safety aspect taken into consideration during safety aspect operation of the equipment and process of the product.
Checked By: __________________
Validation Procedure for Performance Verification of Packing on Cartonator :
Carryout the validation exercise as per the validation protocol
| Product : | |
| Batch Number : | |
| Date of Validation : |
Acceptance criteria for Performance Verification of Packing on Cartonator :
Refer Point No. -15
Non Compliance:
Details of deviations:
| Deviation Report No. / dated | Checked by |
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Details of OOS results:
| OOS Report No. / dated | Checked by |
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Type of validation:
Concurrent Validation:
Frequency for Performance Verification of Packing on Cartonator :
One Validation exercise per year
Results :
| Sr. No. |
Checks |
Acceptance Criteria | Observations |
| 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 |
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| 6. | Carton / leaflet loading sensor | Shows minimum level on screen and after 1 minute machine should stop automatically |
| Sr. No. |
Checks |
Acceptance Criteria | Observations |
| 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 | |
Summary of findings of experiment (inference) :
Recommendation (Including requirements of any additional documentation ):
Team approval :
__________ ___________________ _________________
Production Engineering Quality Assurance
Date : Date: Date:
Review (inclusive of follow up action, if any) :
Approved by :
_________________________ ________________
Plant Quality Assurance Plant Head
Date: Date:
Annexures:
Abbreviations:
OOS : Out of specification
SOP : Standard Operating Procedure
