Standard Operating Procedure for Batch Reactor

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Batch Reactor used in the pharmaceutical manufacturing of otic dosage forms to ensure controlled batch processing.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the Batch Reactor in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the Batch Reactor as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of batch processing.
Maintenance Personnel: Responsible for maintaining the Batch Reactor in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Batch Reactor for cleanliness and integrity before use.
4.1.1.2 Ensure all inlet and outlet connections, agitators, and heating/cooling systems are clean and in good condition.
4.1.1.3 Verify that all safety devices and interlocks are functioning properly.

4.1.2 Preparation
4.1.2.1 Clean and sanitize the Batch Reactor and surrounding area.
4.1.2.2 Check and prepare all raw materials and utilities (water, steam, etc.) required for the batch process.
4.1.2.3 Set all process parameters (temperature, agitation speed, pressure) according to batch requirements.

4.2 Operation
4.2.1 Batch Processing
4.2.1.1 Start the Batch Reactor and ensure proper mixing and reaction conditions.
4.2.1.2 Monitor and control process parameters throughout the batch cycle.
4.2.1.3 Add materials or make adjustments as necessary during the batch process.

4.2.2 Quality and Safety Checks
4.2.2.1 Perform in-process checks to verify batch integrity and quality.
4.2.2.2 Record all critical parameters and observations during the batch processing.
4.2.2.3 Implement corrective actions for any deviations from specified parameters.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the batch cycle and ensure all materials are transferred or discharged safely.
4.3.1.2 Clean and sanitize the Batch Reactor and associated equipment thoroughly.
4.3.1.3 Perform post-operation checks to ensure no residual material in the Batch Reactor.

4.3.2 Maintenance
4.3.2.1 Clean reactor vessel, agitators, and heating/cooling jackets after each batch.
4.3.2.2 Perform preventive maintenance on valves, sensors, and control systems.
4.3.2.3 Document all maintenance activities and update maintenance records accordingly.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Batch records for each batch processed
Maintenance records
Calibration records for temperature and pressure sensors

7) Reference, if any

Manufacturer’s manual for the Batch Reactor
Pharmacopeial guidelines for pharmaceutical batch processing

8) SOP Version

Version 1.0