Standard Operating Procedure for Maintenance of Batch Processing Equipment

1) Purpose

The purpose of this SOP is to establish guidelines for the maintenance and operation of batch processing equipment in pharmaceutical manufacturing facilities to ensure efficient batch production processes and product quality.

2) Scope

This SOP applies to all batch processing equipment used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Batch Processing Equipment Technician or designated personnel are responsible for the maintenance and operation of batch processing equipment.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for batch processing equipment based on manufacturer recommendations and operational requirements.
   2. Inspect equipment components such as vessels, agitators, pumps, and control systems regularly for wear, alignment, or contamination.
2. Cleaning and Sterilization
   1. Follow standard operating procedures for cleaning and sterilizing batch processing equipment to prevent cross-contamination and ensure product integrity.
   2. Use approved cleaning agents and sterilization methods suitable for equipment materials.
3. Performance Verification
   1. Conduct performance verification tests to ensure batch processing equipment operates within specified parameters such as temperature control, mixing efficiency, and product yield.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for batch processing equipment malfunctions, process deviations, or other incidents.
   2. Train personnel on emergency