SOP for De-blistering Machine
Standard Operating Procedure (SOP)
Here is a complete Standard Operating Procedure (SOP) for a De-blistering Machine, which is used to recover tablets or capsules from rejected or damaged blister packs in pharmaceutical operations.
1. Purpose
To define the procedure for operating and cleaning the de-blistering machine used for recovering tablets or capsules from rejected blister packs in a controlled and GMP-compliant manner.
2. Scope
Applicable to all production personnel involved in de-blistering activities using the de-blistering machine in the packaging area.
3. Responsibility
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Machine Operator: Operate and clean the machine as per SOP.
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Production Supervisor: Ensure compliance and supervise activities.
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QA/QC: Approve recovered product for further use and verify cleaning.
4. Equipment/Materials Required
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De-blistering Machine
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Rejected blister packs
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Collection trays (clean and labeled)
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Cleaning materials and tools
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Personal Protective Equipment (PPE)
5. Procedure
5.1 Pre-Operation Checks
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Ensure the machine is clean and labeled “Cleaned.”
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Verify the machine is calibrated (if applicable).
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Check for proper assembly and working condition of the rollers and collection trays.
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Ensure the area is clean and ready for operation.
5.2 Operation Procedure
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Wear appropriate PPE.
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Collect and verify the quantity of blister packs to be de-blistered as per the rejection note.
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Switch ON the main power supply.
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Feed blister packs manually into the machine, ensuring alignment.
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Allow the machine to separate tablets/capsules into the collection tray.
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Periodically check the recovered product for physical integrity and absence of damage.
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Stop the machine once all material is processed.
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Switch OFF the power and document the batch details.
5.3 Post-Operation
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Weigh and record the quantity of recovered tablets/capsules.
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Send for QA inspection and approval.
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Label recovered product as “De-blistered Material – For QA Approval.”
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If any tablets are damaged or contaminated, dispose of them as per SOP for waste handling.
5.4 Cleaning Procedure
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Ensure the machine is powered off and unplugged.
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Dismantle rollers, trays, and product contact parts.
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Clean all parts with purified water and approved detergent.
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Rinse thoroughly and dry completely.
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Wipe external surfaces with a clean cloth.
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Reassemble parts or store them in a clean area.
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Label the machine as “Cleaned.”
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Record the cleaning activity in the equipment logbook.
6. Safety Precautions
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Always wear gloves and protective eyewear.
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Do not insert fingers into the feed rollers during operation.
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Immediately report any malfunction or unusual noise.
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Ensure no mix-up of batches by labeling containers correctly.
7. Documentation
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Equipment usage log
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Cleaning log
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Recovered material record
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QA inspection report
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