Standard Operating Procedure for Sterile Holding Tank

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Sterile Holding Tank used in the pharmaceutical manufacturing of otic dosage forms to ensure the sterility and integrity of the stored product.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the Sterile Holding Tank in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the Sterile Holding Tank as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of the stored product.
Maintenance Personnel: Responsible for maintaining the Sterile Holding Tank in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Sterile Holding Tank for cleanliness and integrity before use.
4.1.1.2 Ensure all connections, valves, and seals are secure and free of leaks.
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 Sterile Holding Tank and surrounding area.
4.1.2.2 Ensure that the tank is empty and dry before sterilization.
4.1.2.3 Set up the tank for sterilization according to the manufacturer’s instructions.

4.2 Operation
4.2.1 Sterilization Process
4.2.1.1 Start the sterilization process and monitor parameters (temperature, time, pressure).
4.2.1.2 Ensure the sterilization cycle is completed as per validated procedures.
4.2.1.3 Verify sterility of the tank post-sterilization using appropriate methods.

4.2.2 Filling and Storage
4.2.2.1 Connect the sterile transfer line to the Sterile Holding Tank.
4.2.2.2 Transfer the product into the tank under aseptic conditions.
4.2.2.3 Monitor storage conditions (temperature, pressure) to maintain sterility.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the transfer of the product and ensure the tank is properly sealed.
4.3.1.2 Clean and sanitize the tank and associated equipment.
4.3.1.3 Perform post-operation checks to ensure no residual product or contamination in the tank.

4.3.2 Maintenance
4.3.2.1 Clean and inspect the tank and connections after each batch.
4.3.2.2 Perform preventive maintenance on seals, valves, and sensors.
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 sterilization and storage batch
Maintenance records
Calibration records for temperature and pressure sensors

7) Reference, if any

Manufacturer’s manual for the Sterile Holding Tank
Pharmacopeial guidelines for sterile product storage

8) SOP Version

Version 1.0