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

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

Procedure

Checking:
  • Take the strips from the conveyer 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 accordingly with the size of 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 product in S.S. Container and rejected products in polybags.
  • Re-pack the good product immediately online and destroyed rejected product in presence of QA. Officer.


Precaution
  • Wear hand gloves, 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 is applicable 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

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