SOP for Sieve Replacement and Calibration

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

1. Inspect the existing sieves for any signs of damage, wear, or distortion that may affect their performance.
2. If any sieves are found to be damaged or not meeting the required specifications, mark them for replacement.
3. Obtain the replacement sieves from the designated storage area, ensuring that they are clean and in good condition.
4. Label each sieve with relevant information, such as sieve size, manufacturer details, and identification number.
5. Carefully remove the old sieves from the sieving equipment and place them in a designated container for disposal or recycling.
6. Install the new sieves in the equipment, ensuring that they are properly aligned and securely fixed.

4.2.