Performance Qualification of Colour Camera System for Blister Packing Machine

Function of camera in Blister Packing Machine :

The Color Camera System is to be attached on to the blister packing machine.  It is designed to detect and reject the defective blisters during blistering of the product.

It can inspect tablets or capsules (hard or soft gelatin) blistered in following types of material of construction with maximum blister dimension of 200 x 160 mm.

PVC or PVDC (Clear, Color or Opaque)

ALU/ALU

It can detect and reject the blisters having following defects:-

Broken tablets, damaged capsules

Partially or fully empty blister.

Blisters containing products of different size or shape.

Product having spots (which is not its specification)

Blisters containing foreign particles.

PERFORMANCE QUALIFICATION REPORT :

Performance is checked by performing the following tests.

Performed all the tests at 3 different speeds of blister packing machine and for the entire track and the details of the product used for performance qualification and observations shall be recorded in the following tables.

Minimum Speed, Optimum Speed and Maximum speed of Machine :

Product Name:                                                        Batch No.:        

Batch Size:                                                               Pack Size:

Sr. No.TestTest Procedure  Acceptance Criteria
1Verification of rejection of blister without product (Completely empty)Create the blisters without product and run the blister packing machine.
Check whether empty blisters are rejected by system or not. Repeat for 3 times.
All empty blisters shall be rejected by the system.
2Verification of rejection of one empty pocket.Create blisters with missing product between two good blisters. That is one pocket should not have product.
Check whether the same is rejected by system.
Repeat for 3 times at 3 different positions for all the blisters in the track.
All blisters with missing product should be rejected by the system.
3Verification of rejection of spots discoloration.Create the spot on product with pen/marker.
Place the product with spot facing towards camera in the blister and run the blister packing Machine.
Check whether the product is rejected or not by system. Repeat for 3 times at 3 different positions for all the blisters in the track.
All blisters with products having spots should be rejected by the system.
4Verification of rejection for broken units.Insert broken product in a blister and run the blister packing machine.
Check whether the product is rejected or not by system. Repeat for 3 times as approximately 10%, 25% and 50% breakage of product.% of broken tablet shall be done on weight basis. Take the weight of intact tablet and break the edges of the tablets to achieve required % breakage.
All blisters with broken product should be rejected by the system.
Sr. No.TestTest Procedure  Acceptance Criteria
5Verification of rejection of object different colour.            Create the object of different colour of same product with methylene blue and run the blister packing machine.
Check whether the product is rejected by system. Repeat for 3 times by placing the different product at 3 different positions in the blister.
All blisters with different colour product should be rejected by the system.
6Verification of the effect of the changes in the tolerance value for the area and spot.  Set the tolerance value at 5 and check for spot on the tablet and 10% broken tablets.
Check whether the product is rejected by system. Perform the test at different tolerance. i.e. 10 & 20.
All blisters with defective product should be rejected by the system.
7Verification of the count i.e. no of packs between the camera and the punching tool for the rejection of the defected blister.Enter the count for rejection between the camera and punching tool correctly.  Defected blister shall get rejected after punching.    
8Verification of the count for the rejected blisters during the packing.            Ensure the count for each type of rejection is zero.
Run the machine with the different type of defects and collect the blisters after rejection separately as per the type of defect.
Check whether the count shown in the screen matches with the collected rejection of the blister as per the type of defect or not.  
The count for the rejected blisters of each type should match with the collected blisters after rejection.

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