SOP for Operating Procedure of Blister Pack Machine

OBJECTIVE

To lay down a procedure for operation of blister pack machine.

SCOPE

This procedure applies for packing department in Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY

The operator is responsible for implementation of the process.

The packing In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE

Select the correct change parts for select product pack size from cupboard.
Fix the gears for required cutting and printing and fix the Blister forming roller and counter sealing Roller to machine.
Fix the cutting unit.
Fix the metallic stereos on cutter for embossing B.No. Manufacturing date and expiry date.
Fix the bowl hopper and set the feeding chute.
Switch ‘ON’ the cooling system.
Switch on the heater and set temperature of Blister forming roller to (165-180^oC) and counter Sealing roller to (180-200^oC.)
Supply compressed air and it should be regulated to 6 kg and the condensed water should be removed from the pressure valve regularly.
Fix the PVC at the bottom side and Aluminium / Glassine foil on top.
The product to be packed is transferred in to the hopper and ensure that the tablets or capsules flow smoothly from hopper to feeding chute.
Set the vibrator for continuous smooth flow to chute.

After setting is completed, switch ‘ON’ the machine and engage Blister forming heater and counter sealing heater.
Switch ‘ON’ the vibrator and collect 10 - 15 packs for checking of overprinted matters, clarity and for leak test.
If these preliminary checks are satisfactory, continue the Blister packing.
The Strips coming out of machine should be inspected for defect such as misprint, cuts on foil, missing product, improper seal and Blister defect. The good strips should be collected, counted and packed into cartons. The rejected strips should be collected separately and then taken up for recovery of product.
All the operation details shall be entered in the equipment usage log.

REFERENCE(s)

Nil.

ABBREVIATION(s)

Q.A : Quality Assurance

SOP : Standard Operating Procedure

No. : Number

P.D : Production

ANNEXURE(s)

Nil.

REVISION CARD

Nil.