Standard Operating Procedure for Sealing and Capping of Vials
1) Purpose
The purpose of this SOP is to define the procedures for sealing and capping vials to ensure the integrity and sterility of injection products.
2) Scope
This SOP applies to all personnel involved in sealing and capping vials at [Company Name] used for the production of intramuscular, subcutaneous, and intravenous injection products.
3) Responsibilities
The responsibilities of this SOP include:
– Production Operators: Performing sealing and capping of vials according to the SOP.
– Maintenance Personnel: Ensuring the sealing and capping equipment is in good working condition.
– Quality Assurance (QA) Department: Reviewing and approving sealing and capping procedures and records.
4) Procedure
4.1 Preparation for Sealing and Capping
4.1.1 Ensure the sealing and capping area is clean and disinfected.
4.1.2 Verify that all equipment is sterilized and ready for use.
4.1.3 Ensure that vials and caps are sterilized and ready for use.
4.2 Sealing and Capping Process
4.2.1 Set up the sealing and capping equipment according to the manufacturer’s instructions.
4.2.2 Perform a pre-use check to ensure the equipment is functioning correctly.
4.2.3 Place the filled vials in the sealing machine and ensure proper alignment.
4.2.4 Operate the sealing machine
4.2.5 Immediately cap the sealed vials using the capping machine or manual process.
4.3 Quality Control Checks
4.3.1 Inspect sealed and capped vials to ensure proper sealing and capping.
4.3.2 Perform leak tests to verify the integrity of the seal.
4.3.3 Record test results and compare them with established acceptance criteria.
4.3.4 If any vials fail the quality checks, investigate the cause and take corrective actions.
4.4 Shutdown and Cleanup
4.4.1 Once sealing and capping are complete, shut down the equipment according to the manufacturer’s instructions.
4.4.2 Clean and disinfect the sealing and capping equipment and surrounding area.
4.4.3 Perform a post-use check to ensure the equipment is ready for the next operation.
4.5 Documentation
4.5.1 Maintain records of all sealing and capping operations, including setup, quality control checks, and maintenance activities.
4.5.2 Ensure all records are signed and dated by the responsible personnel.
5) Abbreviations, if any
– QA: Quality Assurance
6) Documents, if any
– Sealing and Capping Operation Records
– Quality Control Test Records
– Maintenance Logs
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Sealing and Capping Equipment Manufacturer’s Manual
8) SOP Version
Version 1.0