Standard Operating Procedure for Using Blister Packing Machine
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the blister packing machine used in the pharmaceutical manufacturing of otic dosage forms to ensure accurate packaging of individual doses.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the blister packing machine in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the blister packing machine as per this SOP.
Quality Control (QC) Personnel: Responsible for inspecting blister packs for quality and accuracy.
Maintenance Personnel: Responsible for maintaining the blister packing machine in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the blister packing machine is installed on a stable, level surface.
4.1.1.2 Verify that all parts and components, including the forming and sealing stations, are clean and free of debris.
4.1.1.3 Check that the machine is calibrated for the specific blister size and product configuration.
4.1.2 Setup
4.1.2.1 Load the blister packing material and ensure it is aligned correctly with the forming station.
4.1.2.3 Perform a trial run to adjust settings and verify proper forming and sealing of blisters.
4.1.3 Packaging Process
4.1.3.1 Place the product into the formed blisters manually or automatically depending on machine capabilities.
4.1.3.2 Ensure that each blister cavity is filled accurately and uniformly.
4.1.3.3 Activate the sealing process to securely seal the blisters, ensuring product integrity and tamper resistance.
4.1.4 Inspection and Labeling
4.1.4.1 Inspect the sealed blister packs for quality, including seal integrity and presence of any defects.
4.1.4.2 Apply labels or print batch information on the blister packs as per regulatory requirements.
4.1.4.3 Verify that each blister pack is correctly labeled with product information and expiration dates.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the blister packing machine’s temperature, pressure, and cycle settings.
4.2.1.2 Verify the accuracy of the forming and sealing processes.
4.2.1.3 Record the results in the equipment log.
4.2.2 Monthly Calibration
4.2.2.1 Conduct a full calibration of the blister packing machine monthly using standard test methods.
4.2.2.2 Document the calibration results and any adjustments made.
4.3 Maintenance
4.3.1 Routine Maintenance
4.3.1.1 Clean the forming and sealing stations daily to prevent buildup of product residue.
4.3.1.2 Inspect and replace heating elements and seals as needed to maintain seal integrity.
4.3.1.3 Lubricate moving parts according to manufacturer recommendations.
4.3.2 Troubleshooting
4.3.2.1 If the blister packing machine fails to form or seal blisters properly, refer to the manufacturer’s manual for troubleshooting.
4.3.2.2 Contact maintenance personnel for repairs if issues cannot be resolved.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Packaging log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the blister packing machine
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0