Standard Operating Procedure for Lot Coding Machine
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Lot Coding Machine used in the pharmaceutical manufacturing of otic dosage forms to ensure accurate and legible lot coding on the product packaging.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Lot Coding Machine in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Lot Coding Machine as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the accuracy and legibility of the lot codes.
Maintenance Personnel: Responsible for maintaining the Lot Coding Machine in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Lot Coding Machine for cleanliness and integrity before use.
4.1.1.2 Ensure all connections, printers, and sensors are secure and functional.
4.1.1.3 Verify that all safety devices and interlocks are functioning properly.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the Lot Coding Machine and surrounding area.
4.1.2.2 Set up the machine with the correct lot code
4.1.2.3 Ensure the printer heads and ink cartridges are properly installed and functional.
4.2 Operation
4.2.1 Lot Coding Process
4.2.1.1 Start the Lot Coding Machine and ensure it is running smoothly.
4.2.1.2 Place product packaging on the conveyor belt for lot coding.
4.2.1.3 Monitor the lot coding process to ensure accuracy and legibility of codes.
4.2.1.4 Adjust the print settings if necessary to maintain code quality.
4.2.2 Quality Control
4.2.2.1 Periodically check coded packaging for accuracy and legibility of lot codes.
4.2.2.2 Document all QC checks and results.
4.2.2.3 Take corrective actions if deviations are observed.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the lot coding process and ensure all packaging is correctly coded.
4.3.1.2 Clean and sanitize the printer heads, conveyors, and machine components.
4.3.1.3 Perform post-operation checks to ensure no residual ink or contamination in the machine.
4.3.2 Maintenance
4.3.2.1 Clean and inspect the machine components after each batch.
4.3.2.2 Perform preventive maintenance on printer heads, ink cartridges, and sensors.
4.3.2.3 Document all maintenance activities and update maintenance records accordingly.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Batch records for each lot coding batch
Maintenance records
Calibration records for print settings
7) Reference, if any
Manufacturer’s manual for the Lot Coding Machine
Pharmacopeial guidelines for pharmaceutical lot coding processes
8) SOP Version
Version 1.0