SOP for De-Stripping and De-Blistering

OBJECTIVE

To provide a procedure for de-stripping and de-blistering of strip-packed and blister-packed dosage forms respectively.

SCOPE

The procedure applies to all the strip packs and blister packs of a batch that does not conform to specification.

RESPONSIBILITY

The operator is responsible for carrying out the activity as per this SOP.

The Packing supervisor shall ensure that the procedure is being followed.

The Production Manager / QA Manager shall give approval for commencing the activity.

PROCEDURE

• The de-stripping activity shall be done on all the strip-packed dosage forms of a batch that do not conform to specifications.
• The de-stripping activity shall be done either online or offline.
• On-line de-stripping: De-stripping when the strip packing activity of a batch is in progress.
• Off-line de-stripping: De-stripping when the strip packing activity of a batch is completed.

• Wear a facemask, gloves, and other protective gear before initiating the activity.

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• De-strip the tablets or capsules and collect them in a separate clean polythene bag/drum.
• The polythene bag/drum in which the de-stripped tablets or capsules are placed shall be appropriately labeled.
• During de-stripping, the damaged tablets or capsules should be retained in a separate labeled polythene bag for final yield reconciliation or reprocessing.
• Send the de-stripped tablets or capsules for re-stripping.

NOTE: The same procedure shall apply to de-blister the blister-packed dosage form.

ABBREVIATIONS

SOP: Standard Operating Procedure.

QA: Quality Assurance.

REVISION HISTORY

Nil

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