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SOP on Operating the De-blistering Machine

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Procedure for Operating the De-blistering Machine, It is used to De-blister the good blister while packing pharmaceutical products.

A blister is kept inside machine to de-blister

1.0 Objective: This procedure establishes guidelines for the operation of the de-blistering machine.

2.0 Scope: This procedure is applicable to the operation of the de-blistering machine within the production department.

3.0 Responsibility:
Operator, Officer, Executive – Production Department
Manager – Production Department

4.0 Definitions:
Not Applicable (NA)

5.0 Procedure:
5.1 Equipment Setting
5.1.1 Turn off the main power from the electric panel.
5.1.2 Remove the lower guard on the pack entry side to access the support wheels.
5.1.3 Relieve the pressure between the support wheels and the knurled roller by adjusting the external adjusting segment.
5.1.4 Loosen the clamp screw of the blister guides and adjust them to match the pockets. Ensure that the center support wheel aligns precisely between the two rows of blisters.
5.1.5 Adjust the side support wheels to coincide with the blister guides. For packs with minimal sealing margins, the side support rollers can be set 1mm within the blister guides for proper grip.
5.1.6 Set the nip between the top knurled roller and bottom support wheels so that the top knurled roller rotates only when a pack is inserted.
5.1.7 Visually set the wheel spacing by inserting a pack into the blister guides, rotating the motor by hand, and observing tablet removal.

5.2 Operation
5.2.1 After receiving line clearance from Quality Assurance (QA), affix the ‘UNDER PROCESS’ label onto the machine.
5.2.2 Record the batch start time in the equipment usage log sheet.
5.2.3 Turn on the main power from the electric panel.
5.2.4 Manually feed blister packs into the machine through the blister guides. The wheels and knurled roller will handle the packs.
5.2.5 The wheels should run between adjacent rows of products, providing support to the pack while the knurled roller expels the product.
5.2.6 The pressure between the wheels and roller ensures a firm grip during operation.
5.2.7 The expelled product will be collected in the tray.
5.2.8 Record the completion time of the de-blistering machine in the equipment usage log sheet.
5.2.9 Turn off the main power from the electric panel.
5.2.10 Attach the ‘TO BE CLEANED’ label to the machine at the end of the batch.

Note: If the blister is not adjusted with the machine, manually defoil the blisters.

6.0 Abbreviations:
QA: Quality Assurance
SOP: Standard Operating Procedure

7.0 References:
SOP: SOP on Making entries in equipment usage and cleaning log sheet.

8.0 Annexures:

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