Standard Operating Procedure for Bottle Filling and Capping Process

Purpose

The purpose of this SOP is to establish procedures for the efficient and controlled filling and capping of bottles, ensuring accuracy, quality, and compliance with regulatory standards.

Scope

This SOP applies to all personnel involved in the bottle filling and capping process, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for executing the bottle filling and capping process according to the established procedures.
• Technicians: Responsible for monitoring and maintaining filling and capping equipment to ensure proper functionality.
• Quality Control Personnel: Responsible for monitoring and ensuring compliance with the bottle filling and capping SOP.

Procedure

1. Inspect the bottle filling and capping equipment for any visible damage or defects before each use.
2. Ensure that the equipment is clean, free from residues, and calibrated before starting the filling and capping process.
3. Verify that all materials, including bottles, caps, and product labels, are properly labeled and approved for use.
4. Set up the filling machine according to the approved specifications for fill volume, speed, and product type.
5. Load the bottles onto the filling line and initiate the filling process, monitoring for accuracy and consistency.
6. Adjust the filling parameters on the machine, including fill volume and speed, according to the approved specifications.
7. Inspect filled bottles for proper fill levels and product integrity, performing periodic checks to ensure uniformity.
8. If adjustments to the filling parameters are necessary, document the changes made and the reason for the adjustments.
9. Transfer filled bottles to the capping station and set up the capping machine according to the approved specifications.
10. Initiate the capping process and monitor the machine to ensure proper cap placement and sealing.
11. Perform periodic checks on capped bottles to ensure proper cap tightness and package integrity.
12. If adjustments to the capping parameters are necessary, document the changes made and the reason for the adjustments.
13. Perform in-process checks, such as visual inspections and weight verifications, to assess the quality of filled and capped products.
14. Collect samples for quality control testing, including fill volume and cap tightness.
15. Submit samples to the quality control laboratory, ensuring that the filled and capped products meet the predefined acceptance criteria.
16. If the products pass quality control, proceed with further processing steps as per the formulation requirements.
17. If the products fail quality control, initiate an investigation, document the findings, and implement corrective actions as needed.
18. Complete the logbook or batch record with all pertinent information, including any adjustments made during the filling and capping process.
19. Clean and sanitize the filling and capping equipment regularly according to the approved cleaning procedures.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Filling and Capping Logbook
• Quality Control Test Results
• Maintenance and Calibration Records
• Deviation and Corrective Action Logs

Reference

USP General Chapter <1151> – Pharmaceutical Dosage Forms

SOP Version

Version 1.0