Standard Operating Procedure for Using Cartoning Machine

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the cartoning machine used in the pharmaceutical manufacturing of otic dosage forms to automate the packaging of blister packs into cartons.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the cartoning machine in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the cartoning machine as per this SOP.
Quality Control (QC) Personnel: Responsible for inspecting cartons for quality and accuracy.
Maintenance Personnel: Responsible for maintaining the cartoning machine in proper working condition.

4) Procedure

4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the cartoning machine is installed on a stable, level surface in the packaging area.
4.1.1.2 Verify that all parts, including the carton magazine, product feed, and coding systems, are clean and ready for operation.
4.1.1.3 Check that the machine is set up for the correct carton size and product configuration.

4.1.2 Setup
4.1.2.1 Load the carton blanks into the magazine and adjust the cartoning machine settings as per product specifications.
4.1.2.2 Ensure that the product feed aligns with the carton opening for accurate placement.
4.1.2.3 Perform a trial run to adjust settings and verify proper carton loading and closing.

4.1.3 Cartoning Process
4.1.3.1 Feed blister packs into the cartoning machine at the specified rate.
4.1.3.2 Verify that each carton is accurately filled with the correct number of blister packs.
4.1.3.3 Activate the carton closing mechanism to securely seal each carton.

4.1.4 Inspection and Labeling
4.1.4.1 Inspect filled cartons for quality, including carton integrity and alignment of product.
4.1.4.2 Apply labels or print batch information on the cartons as per regulatory requirements.
4.1.4.3 Verify that each carton 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 cartoning machine’s feeding, filling, and sealing mechanisms.
4.2.1.2 Verify the accuracy of carton placement and closure.
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 cartoning 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 cartoning machine components daily to remove product residues and ensure smooth operation.
4.3.1.2 Inspect and replace worn parts such as belts and seals to prevent downtime.
4.3.1.3 Lubricate moving parts according to manufacturer recommendations.

4.3.2 Troubleshooting
4.3.2.1 If the cartoning machine fails to fill or close cartons 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 cartoning machine
Regulatory guidelines for equipment calibration and maintenance

8) SOP Version

Version 1.0