Standard Operating Procedure for Operation of Sifter

1. Purpose

The purpose of this SOP is to provide guidelines for the safe and efficient operation of sifters in the pharmaceutical industry to ensure product quality and compliance with regulatory standards.

2. Scope

This SOP applies to all personnel responsible for operating sifters in the pharmaceutical facility.

3. Responsibilities

• 3.1 Operator: Responsible for the proper operation of the sifter as outlined in this SOP.
• 3.2 Supervisor: Responsible for overseeing and ensuring compliance with this SOP.

4. Procedure

Follow these steps for the proper operation of the sifter:

4.1 Ensure the sifter is placed on a stable and level surface.

4.2 Inspect the sifter for any visible damage or loose components. Do not operate if any issues are detected; report them to the supervisor for maintenance.

4.3 Verify that the product to be sifted is appropriately prepared and ready for processing.

4.4 Power on the sifter and ensure that it is set to the desired operational settings (e.g., vibration intensity, screen size).

4.5 Load the prepared product into the sifter’s feeding mechanism or hopper, ensuring not to overload it beyond its capacity.

4.6 Start the sifting process according to the manufacturer’s instructions, adjusting settings as necessary to achieve the desired results.

4.7 Monitor the sifting process for any irregularities, such as clogs or unusual noises. Immediately stop the sifter if any issues are detected.

4.8 Collect and store the sifted product in appropriate containers, following proper labeling and handling procedures.

4.9 After operation, power off the sifter, and clean it following the “CLEANING OF SIFTER SOP” (insert link/reference).

4.10 Record the operation details, including batch information and any deviations from normal operation, in the equipment logbook.

5. Abbreviations

No specific abbreviations are used in this SOP.

6. Documents

The following documents are relevant to this SOP:

• Equipment Logbook
• Manufacturer’s Operation Manual (if applicable)

7. References

No external references are applicable to this SOP.

8. SOP Version

This is Version 1.0 of the SOP for Operation of Sifter, issued on [Date].