Standard Operating Procedure for Temperature Control during FFS Operations

1) Purpose

The purpose of this SOP is to establish guidelines for maintaining optimal temperature control during Form-Fill-Seal (FFS) operations to ensure product quality and compliance with regulatory requirements.

2) Scope

This SOP applies to the monitoring and control of temperature parameters in FFS machines during pharmaceutical manufacturing processes.

3) Responsibilities

3.1 Production Operators

• Monitor and record temperature readings during FFS operations.
• Take corrective actions in case of temperature deviations.

3.2 Engineering Department

• Calibrate temperature sensors and controllers regularly.
• Address equipment-related issues affecting temperature control.

4) Procedure

4.1 Temperature Monitoring

1. Place temperature probes at critical points on the FFS machine.
2. Record temperature readings at specified intervals during operation.

4.2 Temperature Control

1. Adjust machine settings to maintain temperatures within specified ranges.
2. Implement immediate corrective actions for out-of-specification temperatures.

4.3 Calibration of Temperature Sensors

1. Schedule and perform regular calibration of temperature sensors.
2. Document calibration activities and maintain records.

4.4 Response to Temperature Deviations

1. Investigate root causes of temperature deviations.
2. Implement corrective and preventive actions (CAPA) to prevent recurrence.

5) Abbreviations, if any

FFS: Form-Fill-Seal
CAPA: Corrective and Preventive Actions

6) Documents, if any

• Temperature Monitoring Logs
• Calibration Certificates
• CAPA Reports

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ISO 9001: Quality management systems — Requirements

8) SOP Version

Version 1.0