Standard Operating Procedure for Operation of Mixing Tanks

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of mixing tanks in pharmaceutical manufacturing to ensure consistent product quality and safety.

2. Scope

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

3. Responsibilities

• Production Operator: Responsible for carrying out the mixing tank operation as per this SOP.
• Supervisor: Oversees the operation and ensures compliance with this SOP.

4. Procedure

4.1. Pre-Operation Checks

1. Ensure that the mixing tank and its components are clean and free from residues from previous operations.
2. Verify that all required raw materials and ingredients are available and have been properly labeled.
3. Inspect the mixing tank for any visible damage or defects and report any issues to the supervisor.

4.2. Ingredient Addition

1. Weigh and measure the required raw materials and ingredients according to the approved batch record or formula.
2. Add the ingredients to the mixing tank in the specified order and record the addition process accurately.

4.3. Mixing Process

1. Start the mixing equipment according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Monitor the mixing process closely to ensure that the materials are thoroughly mixed and achieve the desired consistency and uniformity.
3. Record the mixing time, speed, and any deviations from the standard procedure.

4.4. Sampling

1. Collect representative samples of the mixture at defined intervals during the mixing process for quality control and testing purposes.
2. Label and document the samples accurately, including the sampling time and location.

4.5. Post-Mixing Checks

1. Stop the mixing equipment and ensure it is properly cleaned and sanitized after use.
2. Perform visual inspections of the mixed product to check for any abnormalities or inconsistencies.
3. Compare the final product with the quality specifications and document any deviations.

4.6. Documentation

Properly document all aspects of the mixing tank operation, including batch records, ingredient measurements, mixing parameters, sampling records, and any deviations from the procedure. Maintain records in a secure and accessible location for regulatory inspection.

5. Abbreviations

• GMP: Good Manufacturing Practices

6. Reference

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

7. SOP Version

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