Standard Operating Procedure (SOP) for Sieving Process and Sieve Inspection
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the sieving process and sieve inspection in order to ensure the quality and integrity of pharmaceutical products.
2. Scope
This SOP applies to all personnel involved in the sieving process and sieve inspection within the pharmaceutical company.
3. Responsibilities
- The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
- The Production department is responsible for carrying out the sieving process.
- The Quality Control (QC) department is responsible for performing the sieve inspection.
4. Procedure
The following steps outline the procedure for the sieving process and sieve inspection:
4.1. Sieving Process
- Ensure that the sieving equipment is clean and in good working condition before starting the process.
- Weigh the material to be sieved accurately according to the specified quantity.
- Set up the sieve stack by placing the appropriate sieves in descending order of their mesh sizes.
- Secure the sieve stack properly and ensure that it is stable during the sieving process.
- Start the sieving process by turning on the equipment and adjusting the vibration settings to the recommended level.
- Allow the material to pass through the sieves for the specified duration.
- Stop the equipment and carefully remove the sieve
stack.
Collect the material retained on each sieve and record the weights accurately.
Transfer the sieved material to the appropriate container, properly labeled with necessary information.
Clean the sieves thoroughly after each use to prevent cross-contamination.
4.2. Sieve Inspection
- Inspect the sieves for any physical damage, such as tears, holes, or bent edges.
- Ensure that the mesh sizes of the sieves are intact and not distorted.
- Verify that the sieves are properly labeled with relevant information, including sieve size, manufacturer details, and identification number.
- Perform regular calibration checks on the sieves to ensure accuracy.
- If any discrepancies or issues are identified during the inspection, immediately report them to the appropriate department for further action.
- Maintain proper documentation of the sieve inspection results for future reference.
5. Abbreviations Used
- QA: Quality Assurance
- QC: Quality Control
- SOP: Standard Operating Procedure
6. Documents
- Sieve Inspection Log
- Equipment Cleaning and Maintenance Log
7. References
No specific references are applicable for this SOP.
8. SOP Version
This is version 1.0 of the SOP for Sieving Process and Sieve Inspection.
