To lay down the procedure for operation of ‘Bliss’, the online inspection system.
This SOP shall be applicable to ‘Bliss’ Machine used for online inspection of checking missing tablets, wrong shape tablets cracked / broken tablets and color difference in tablets during packing in Packing Area in Production Department.
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above
HOD-Production / Assigned Designee
5.1 PROCEDURE FOR CAMERA SETTING:
5.1.1 Production person shall ensure the cleanliness of the machine, its part & area and ‘CLEANED’ label on it, before starting the operation production person get line clearance from Q.A. person and affix status label with Product Name, batch details to Equipment and Area as per BMR.
4.1.2 Switch on the ‘Mains On’. Confirm ‘
in ‘ON’ state. Switch on console unit by pressing ‘Red Color Switch’ on right
side of console unit.
4.1.3 ‘Bliss’ will start functioning. Login screen will appear. Enter the appropriate user name and password. System will enter in ‘Learn / Teach Mode’.
4.1.4 As machine will start running, you will see the blister pack image on screen. You can see “Please set image and press ok button” message on the screen bottom.
4.1.5 Adjust blister pack in yellow region area (ROI) (e.g. Region of Interest) on screen. Once desired image is achieved with all good tablets, click on ‘OK’ button.
4.1.6 On the left hand side you can see the ‘Setting’ tab. set the following parameters appropriately:
· Select Tablet type: According to color of tablet select the choice given.
· Dark/Bright: Select the Contrast for Blister.
· Spot: Keep on for checking black spot on tablet.
· Fill Hole: Keep on if Characters are printed on tablet.
· Total Blisters: Enter the total no. of blisters as per seen in image.
· Tablets per Blisters: Enter the no. of tablets per blister pack.
· Ejection count: Enter the numbers of blister between camera and ejection station on
4.1.7 After setting above values properly, check the indicator ‘Tablets found’. This will give you the total no. of tablets found in the image. If no. of tablets are same as per the tablets seen in image, you will get the message “Press Start to go to Inspection Mode” else “Match Fail” message will be displayed.
4.2.1 You can select the inspection criteria with the help of this button.
4.2.2 Broken, Shape Match, Colour Match: Default Value set for this criteria is true.
4.2.3 Click to cancel these criteria. System will exclude selected criteria from the inspection.
4.2.4 To Save Product, Click on ‘Save Product’, keyboard will appear.
4.2.5 Enter the name of the product to be saved with help of keyboard.
4.2.6 To load product from previously saved products click on ‘Load Product’.
4.2.7 Select the desired product amongst list.
4.3 RUN MODE:
4.3.1 Click on Start button after matching the criteria.
4.3.2 Start running the machine. Inspection will start accordingly.
4.3.3 Total, Good, Bad Indicators can be seen on screen to indicate the status of total number of images.
4.3.4 Shape, Area and color Tolerance values can be changed by clicking on “Tolerance” button.
4.3.5 After completion of operation, put “OFF” the Mains.
4.3.6 Affix the “To be cleaned” status label and fill the “Equipment Log Book” (Annexure-I)
Sufficient trial run should be taken and confirm the rejection mechanism with the help of test pieces before starting actual Operation.
Written Line Clearance should be obtained from Q.A. person before commencing operation and also prior to change over to another Batch of same product or to a new product.
6.1 SOP: Standard Operating Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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