Standard Operating Procedure for Tube Crimping Machine
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Tube Crimping Machine used in the pharmaceutical manufacturing of otic dosage forms to ensure effective and secure crimping of tubes.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Tube Crimping Machine in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Tube Crimping Machine as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of the crimped tubes.
Maintenance Personnel: Responsible for maintaining the Tube Crimping Machine in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Tube Crimping Machine for cleanliness and integrity before use.
4.1.1.2 Ensure all connections, moving parts, and safety guards 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 Tube Crimping Machine and surrounding area.
4.1.2.2 Set up the machine with the correct crimping parameters as per batch
4.1.2.3 Ensure the crimping heads and tools are properly installed and functional.
4.2 Operation
4.2.1 Crimping Process
4.2.1.1 Start the Tube Crimping Machine and ensure it is running smoothly.
4.2.1.2 Place filled tubes in the crimping position.
4.2.1.3 Monitor the crimping process to ensure effective and secure crimps.
4.2.1.4 Adjust the crimping settings if necessary to maintain crimp quality.
4.2.2 Quality Control
4.2.2.1 Periodically check crimped tubes for accuracy and consistency of crimp quality.
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 crimping process and ensure all tubes are correctly crimped.
4.3.1.2 Clean and sanitize the crimping heads, tools, and machine components.
4.3.1.3 Perform post-operation checks to ensure no residual product 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 crimping heads, tools, and moving parts.
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 crimping batch
Maintenance records
Calibration records for crimping settings
7) Reference, if any
Manufacturer’s manual for the Tube Crimping Machine
Pharmacopeial guidelines for pharmaceutical crimping processes
8) SOP Version
Version 1.0