Standard Operating Procedure (SOP) for Sieve Replacement and Calibration
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper replacement and calibration of sieves used in pharmaceutical manufacturing, ensuring accurate particle size analysis and maintaining product quality.
2. Scope
This SOP applies to all personnel involved in the replacement and calibration of sieves within the pharmaceutical company.
3. Responsibilities
- The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
- The Quality Control (QC) department is responsible for performing the sieve replacement and calibration.
4. Procedure
The following steps outline the procedure for the sieve replacement and calibration:
4.1. Sieve Replacement
- Inspect the existing sieves for any signs of damage, wear, or distortion that may affect their performance.
- If any sieves are found to be damaged or not meeting the required specifications, mark them for replacement.
- Obtain the replacement sieves from the designated storage area, ensuring that they are clean and in good condition.
- Label each sieve with relevant information, such as sieve size, manufacturer details, and identification number.
- Carefully remove the old sieves from the sieving equipment and place them in a designated container for disposal or recycling.
- Install the new sieves in the equipment, ensuring that they are properly aligned and securely fixed.
4.2.
Sieve Calibration
- Select a representative sample of particles with known sizes that cover the desired range for calibration.
- Place the calibration sample on the top sieve of the stack and cover it with the lid.
- Start the sieving process and allow it to run for the specified duration.
- Carefully remove each sieve from the stack and collect the material retained on each sieve.
- Weigh the collected material from each sieve using a calibrated balance.
- Record the weights and calculate the percentage of material retained on each sieve.
- Compare the obtained results with the expected values based on the known particle sizes of the calibration sample.
- If any discrepancies are found, take appropriate corrective actions, such as adjusting the equipment or replacing the sieves.
- Maintain accurate calibration records, including the calibration date, sample used, and results obtained.
5. Abbreviations Used
- QA: Quality Assurance
- QC: Quality Control
- SOP: Standard Operating Procedure
6. Documents
- Sieve Replacement Log
- Sieve Calibration Log
7. References
No specific references are applicable for this SOP.
8. SOP Version
This is version 1.0 of the SOP for Sieve Replacement and Calibration.
