Standard Operating Procedure for Calibration of Tube Filling and Sealing Machine

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the calibration of the tube filling and sealing machine used in the formulation of cutaneous products. It aims to ensure that the machine is calibrated accurately to maintain product quality, meet regulatory requirements, and minimize the risk of errors during the filling and sealing process.

Scope

This SOP applies to all personnel involved in the calibration, operation, and maintenance of the tube filling and sealing machine in the formulation, manufacturing, and processing of creams, ointments, gels, and other cutaneous formulations.

Responsibilities

• Production Operators: Responsible for assisting in the calibration process and operating the tube filling and sealing machine in accordance with established procedures.
• Quality Assurance (QA): Responsible for overseeing the calibration process, verifying the accuracy of measurements, and ensuring compliance with regulatory requirements.
• Engineering Department: Responsible for performing the calibration of the tube filling and sealing machine and maintaining calibration records.
• Supervisors: Responsible for coordinating the calibration activities and ensuring that all personnel adhere to safety protocols.

Procedure

1. Preparation: Ensure that the tube filling and sealing machine is clean, sanitized, and free from any product residues.
2. Identification: Identify the critical parameters of the machine that require calibration, such as fill volume, seal integrity, and alignment.
3. Calibration Standards: Obtain calibrated reference standards or equipment traceable to national or international standards for use in the calibration process.
4. Calibration Plan: Develop a detailed calibration plan outlining the calibration procedures, equipment to be used, acceptance criteria, and documentation requirements.
5. Adjustment: Adjust the settings and parameters of the tube filling and sealing machine as necessary to ensure alignment with the calibration standards.
6. Testing: Conduct performance tests on the machine to verify its accuracy and precision in filling and sealing tubes.
7. Documentation: Record all calibration activities in the calibration logbook, including the date, time, calibration standards used, adjustments made, and test results.
8. Verification: QA shall review the calibration records to ensure that the machine meets the specified performance criteria and complies with regulatory requirements.
9. Labeling: Affix calibration labels or tags to the tube filling and sealing machine indicating the calibration status, next due date, and any relevant information.
10. Training: Provide training to personnel involved in the operation and maintenance of the tube filling and sealing machine on proper calibration procedures and techniques.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance

Documents

• Calibration logbook
• Calibration certificates
• Training records
• Deviation reports

Reference

Refer to the manufacturer’s operation manual for the tube filling and sealing machine and regulatory guidelines from authorities such as FDA, EMA, WHO, and ICH for specific requirements related to equipment calibration in pharmaceutical manufacturing.

SOP Version

Version 1.0