Standard Operating Procedure for Cap Sealing Machine in Ocular Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the cap sealing machine to ensure proper sealing of caps on containers containing ocular dosage forms.
2) Scope
This SOP applies to all cap sealing machines used in the manufacturing of ocular dosage forms within the pharmaceutical manufacturing facility.
3) Responsibilities
Production personnel are responsible for operating the cap sealing machine and ensuring that caps are sealed securely and correctly. Quality control personnel are responsible for verifying the integrity of sealed caps and compliance with SOPs.
4) Procedure
4.1 Preparation for Cap Sealing
- Ensure the cap sealing area is clean, organized, and free from contaminants.
- Verify the availability and condition of all equipment, tools, and materials needed for the sealing process.
- Set up the cap sealing machine according to the product specifications and batch records.
- Record the batch number, product name, and quantity of containers to be sealed in the batch production log.
4.2 Cap Sealing Process
- Preparation of Cap Sealing Equipment
- Inspect the containers for any defects or contamination before sealing.
- Load the containers into the cap sealing machine conveyor or fixture.
- Sealing Operation
- Set the sealing parameters on the machine
- Take samples of sealed containers for quality control testing, including cap seal integrity and visual inspection.
- Record the results of quality control tests in the batch production log.
- If any containers fail quality control tests, investigate and take corrective actions before proceeding.
- Remove the sealed containers from the machine and inspect them for any defects or abnormalities.
- Label the sealed containers with the batch number, product name, and expiry date.
- Transfer the sealed containers to the designated storage area under controlled conditions.
4.3 Cleaning and Maintenance
- Clean the cap sealing machine and all associated equipment thoroughly after each batch according to the cleaning SOP.
- Perform routine maintenance checks and ensure all parts are properly maintained and calibrated.
- Document all cleaning and maintenance activities in the equipment logbook.
4.4 Documentation
- Record the details of the cap sealing process, including sealing parameters, in-process checks, and quality control results, in the batch production log.
- Ensure all records are signed and dated by the personnel responsible for the sealing operation.
- Attach a copy of the batch production log to the batch production record for traceability.
4.5 Review and Approval
- The quality assurance department should review sealing procedures and records periodically to ensure compliance with SOPs and regulatory requirements.
- Any discrepancies or deviations should be investigated, documented, and resolved promptly.
- Review and update the SOP as necessary to reflect changes in procedures, regulations, or industry standards.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
- Batch production log
- Batch production record
- Equipment logbook
7) Reference, if any
GMP Guidelines for Pharmaceutical Manufacturing
8) SOP Version
Version 1.0
