SOP for Operating Procedure of Blister Pack Machine

OBJECTIVE

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

SCOPE

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

RESPONSIBILITY

The operator is responsible for the 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 a cupboard.
• Fix the gears for required cutting and printing and fix the Blister forming roller and counter sealing Roller to the machine.
• Fix the cutting unit.

• Fix the metallic stereos on the 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 the 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 into the hopper and ensures that the tablets or capsules flow smoothly from the hopper to the feeding chute.
• Set the vibrator for a continuous smooth flow to the chute.

ALSO READ: SOP for Operation & Cleaning of Strip Packing Machine

• After the setting is completed, switch ‘ON’ the machine and engage the 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 the machine should be inspected for defects such as misprints, cuts on foil, missing product, improper seal and Blister defects. 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

Nil.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No. : Number

P.D: Production

ANNEXURE

Nil.

REVISION HISTORY

Nil.

ALSO READ: SOP for Cleaning Procedure of Blister Pack Machine