Standard Operating Procedure for Pressure Vessel

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Pressure Vessel used in the pharmaceutical manufacturing of otic dosage forms to ensure safe handling of pressurized materials.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the Pressure Vessel as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of materials processed in the Pressure Vessel.
Maintenance Personnel: Responsible for maintaining the Pressure Vessel in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Pressure Vessel for cleanliness and integrity before use.
4.1.1.2 Ensure that all valves, fittings, and safety mechanisms are in good condition.
4.1.1.3 Verify that the Pressure Vessel is calibrated and meets operating specifications.

4.1.2 Preparation
4.1.2.1 Clean and sanitize the Pressure Vessel and surrounding area.
4.1.2.2 Check and prepare all materials and equipment required for pressurization.
4.1.2.3 Ensure that all utilities (steam, water, etc.) are connected and ready for operation.

4.2 Operation
4.2.1 Pressurization Process
4.2.1.1 Power on the Pressure Vessel and begin the pressurization process.
4.2.1.2 Load materials into the Pressure Vessel as per the batch requirements.
4.2.1.3 Monitor pressure and temperature within the vessel during the pressurization process.

4.2.2 Processing
4.2.2.1 Maintain pressure and temperature within specified ranges throughout processing.
4.2.2.2 Agitate or mix materials as required by the process.
4.2.2.3 Record all critical parameters during the processing phase.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the processing cycle and depressurize the Pressure Vessel safely.
4.3.1.2 Remove processed materials from the Pressure Vessel as per procedures.
4.3.1.3 Clean and sanitize the Pressure Vessel and associated equipment thoroughly.

4.3.2 Maintenance
4.3.2.1 Perform post-operation checks to ensure no residual materials or contamination.
4.3.2.2 Regularly inspect and maintain all safety devices and pressure relief valves.
4.3.2.3 Document all maintenance activities and keep maintenance records updated.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Maintenance records
Batch records for each processing cycle
Calibration records for the Pressure Vessel

7) Reference, if any

Manufacturer’s manual for the Pressure Vessel
Pharmacopeial guidelines for pharmaceutical processing under pressure

8) SOP Version

Version 1.0