Standard Operating Procedure for Operation of Storage Tanks

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation and management of storage tanks in pharmaceutical manufacturing. This ensures the safe storage of materials and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of storage tanks within the pharmaceutical manufacturing facility.

3. Responsibilities

• Storage Tank Operator: Responsible for following the procedures outlined in this SOP during tank operations.
• Supervisor: Oversees and verifies compliance with this SOP, including training and documentation.

4. Procedure

4.1. Pre-Operation Checks

1. Inspect the storage tank for any visible damage, leaks, or defects. Report any issues to the supervisor.
2. Ensure that the tank is clean and free from any residues or contaminants from previous operations.
3. Verify that all necessary utilities (e.g., electricity, ventilation) are available and functioning properly.

4.2. Product Transfer

1. Transfer the product or material to be stored into the storage tank using approved transfer equipment and procedures.
2. Ensure that the material is accurately measured and documented.
3. Use appropriate labeling on the tank to indicate the contents, batch/lot number, and expiration date.

4.3. Storage Conditions

1. Store materials in the tank under the recommended storage conditions, including temperature, humidity, and lighting requirements.
2. Monitor and record environmental conditions regularly to ensure compliance with specifications.

4.4. Inventory Management

1. Maintain accurate records of the materials stored in the tank, including quantities, dates of receipt, and expiration dates.
2. Implement a First-In-First-Out (FIFO) inventory system to ensure proper material rotation and prevent product expiration.

4.5. Routine Inspection

1. Regularly inspect the tank for signs of damage, corrosion, or contamination.
2. Check that all tank accessories, such as vents, safety valves, and level indicators, are functioning correctly.

4.6. Documentation

Properly document all aspects of storage tank operation, including pre-operation checks, material transfers, storage conditions, inventory management, and routine inspections. Maintain records in a secure and accessible location for regulatory inspection.

5. Abbreviations

• GMP: Good Manufacturing Practices
• FIFO: First-In-First-Out

6. Reference

[Insert any relevant references or standards applicable to the operation of storage tanks in the pharmaceutical industry.]

7. SOP Version

This is version 1.0 of the “Operation of Storage Tanks SOP,” issued on [insert issuance date].