SOP for Repacking of Online Recovery after De-foiling of Product

Objective

The Objective of this SOP is to provide detailed instructions on checking strips and repacking online recovery after de-foiling.

Scope

The scope of this SOP is to lay down the detailed procedure to check the strip/blister before packing those in inner cartons, the rejected strips/blisters are then de-foiled to recover good tablets/capsules, and those are then inspected and packed to complete the packing. This also provides the precautions to be taken while doing the process.

Responsibility

Performance: Worker, Operator, and Technician Responsible for performing the activity.

Checking: Production Supervisor, Technical Staff, and above to counter-test the activity.

Accountability

HOD: Production/Assigned Designee for Overall Implementation in the System with powerful Procedural management to compliance.

Procedure

Checking:

• Take the strips from the conveyor belt and check for the following parameters: (Pockets: Strips should not have empty pockets.
• Strips should not have punctured or ruptured pockets.
• Strips should not have any broken tablets.

Sealing: Strips should have proper sealing.

Cutting: Strips should have proper cutting.

Overprinting: Printing should be neat & clean, with clear & completely readable batch details.

• Pack the strips if strips are found well in the above checks.
• Collect the rejected strips in the ‘To be recovered’ container.
• Recovery of Product from strips: 

Aluminum strips:

• Cut the strip near pockets carefully avoiding damage to the product.
• Remove the product from opened pockets.
• Collect the product in s.s. container and paste the “To be inspected” label.
• Sort out a good product and collect the good product in S.S. Container and rejected product in polybags.
• Re-pack the good product immediately online and destroy the rejected product.

Blister strips:

• Insert the rejected blisters into the de-blistering machine and set them according to the size of the blister.
• The product will be collected in the S.S. container provided in the machine.
• Inspect the tablets to separate the good ones.
• Collect the good products in S.S. containers and rejected products in polybags.
• Re-pack the good product immediately online and destroy the rejected product in the presence of QA. Officer.

Precaution

• Wear hand gloves, a nose mask at the time of de-foiling and recovery of the product
• Prevent the product from damage at the time of de-foiling and recovery of the product
• This SOP applies to Blister strips and Aluminum strips.
• Necessary precaution for safety concerns and others if applicable as required.

Acceptance Criteria: Only good intact, properly sealed, and over-printed strips should go for packing.

Frequency: As and when strip/blister sealing operation is online.

Annexure

Nil

Abbreviations

SOP: Standard Operating Procedure

BMR: Batch Manufacturing Record

QC: Quality Control

Q.A: Quality Assurance

HOD: Head of the Department

Revision History

Nil

ALSO READ: SOP for De-Stripping and De-Blistering