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
 

 

     
 

 

     
 

 

     

 

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
 

 

 

Details of OOS results:

OOS Report No. /  dated Checked by
 

 

 

 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

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

 

 

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