Standard Operating Procedure (SOP)

Here’s a detailed Standard Operating Procedure (SOP) for an Alu-Alu Blister Packing Machine, commonly used in pharmaceutical manufacturing for packing tablets and capsules in aluminum-aluminum (cold-form) blister packs.

1. Purpose

To define the procedure for setup, operation, and cleaning of the Alu-Alu blister packing machine used for primary packaging of solid oral dosage forms.

2. Scope

This SOP applies to all Alu-Alu blister packing operations in the packaging department.

3. Responsibility

• Machine Operator: Operate and clean the machine as per SOP.

• Packaging Supervisor: Ensure compliance and verify setup and operation.

• QA/QC: Approve line clearance and inspect finished packs.

4. Equipment/Materials Required

• Alu-Alu Blister Packing Machine

• Printed/Plain aluminum foil (forming and lidding)

• Tablets or capsules

• PVC/PVDC (if required)

• Cleaning materials and tools

• Personal Protective Equipment (PPE)

5. Procedure

5.1 Pre-Startup Checks

• Ensure the machine is cleaned, dried, and labeled “Cleaned.”

• Verify availability of correct product, batch record, and packing materials.

• Confirm line clearance by QA.

• Check proper alignment and installation of forming foil, lidding foil, and feeding system.

• Ensure temperature, pressure, and cutting parameters are set as per BMR.

5.2 Operation Procedure

1. Wear appropriate PPE.

2. Switch ON the main power and air compressor.

3. Preheat the forming and sealing stations to required temperatures.

4. Load forming foil and lidding foil into their designated positions.

5. Load tablets/capsules into the feeder hopper.

6. Start the machine in manual mode for trial run:

   • Check blister pocket formation.

   • Verify proper feeding, sealing, and cutting.

7. Once confirmed, switch to auto mode for continuous operation.

8. Monitor critical parameters (temperature, speed, sealing pressure).

9. Perform in-process checks at defined intervals (e.g., sealing integrity, batch code, pack count).

10. Collect and label finished blisters in approved containers.

11. Record all observations and yield calculations in BMR.

5.3 Post-Operation

• Stop the machine and switch OFF main power and air supply.

• Remove all remaining tablets/capsules and packaging materials.

• Perform yield reconciliation and return unused materials to storage.

• Label the machine as “To Be Cleaned.”

• Record the activity in the equipment usage logbook.

5.4 Cleaning Procedure

1. Disconnect power and air supply.

2. Dismantle contact parts such as feeder, chute, sealing plates, and cutting tools.

3. Clean all parts using lint-free cloth and approved cleaning agent.

4. Rinse (if applicable) and allow to dry thoroughly.

5. Wipe external machine surfaces with a clean damp cloth.

6. Reassemble the machine and label it as “Cleaned.”

7. Document the cleaning activity in the logbook.

6. Safety Precautions

• Do not touch heated parts without thermal gloves.

• Ensure all safety guards are in place before operating.

• Avoid overloading feeding trays.

• Always wear full PPE.

• Report any mechanical or electrical faults immediately.

7. Documentation

• Equipment usage log

• Cleaning log

• Batch Packing Record (BPR)

• In-process checks record

• Line clearance and reconciliation record

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