Standard Operating Procedure for Operation of Tablet Thickness Sorter
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic and standardized approach for the proper operation of the Tablet Thickness Sorter. The Tablet Thickness Sorter is a critical equipment used in the pharmaceutical manufacturing process to ensure the quality and uniformity of tablets produced.
Scope
This SOP applies to all personnel involved in the operation and maintenance of the Tablet Thickness Sorter in the pharmaceutical manufacturing facility. It encompasses the necessary guidelines to ensure consistent tablet thickness sorting, adherence to safety protocols, and compliance with relevant quality standards and regulations.
Responsibilities
The following responsibilities are assigned to the relevant personnel:
- Quality Assurance Department: Responsible for reviewing and approving this SOP. Additionally, they are accountable for conducting periodic audits to ensure compliance.
- Production Operators: Responsible for the day-to-day operation of the Tablet Thickness Sorter as per the procedures outlined in this SOP.
- Quality Control Team: Responsible for verifying the effectiveness of the sorting process and ensuring the tablets meet the required specifications.
- Maintenance Team: Responsible for the regular maintenance and calibration of the Tablet Thickness Sorter.
Procedure
The following steps outline the proper operation of the Tablet Thickness Sorter:
- Preparation:
- Ensure that all relevant safety measures are in place before starting the equipment.
- Check and verify the calibration status of the Tablet Thickness Sorter.
- Inspect the sorting trays for cleanliness and ensure they are free from any residues.
- Startup:
- Power on the Tablet Thickness Sorter and allow sufficient time for it to reach the operating temperature.
- Verify that the sorting parameters are set as per the approved manufacturing instructions.
- Sorting Process:
- Carefully load the pre-checked tablets into the sorting trays, ensuring they are evenly distributed.
- Start the sorting process and monitor it closely to detect any abnormalities or malfunctions.
- Regularly inspect the sorted tablets to identify any defects or variations in thickness.
- If any out-of-specification tablets are detected, stop the process immediately and investigate the root cause.
- Shutdown:
- Once the sorting process is complete, power off the Tablet Thickness Sorter.
- Thoroughly clean the equipment and sorting trays to prevent any cross-contamination.
- Documentation:
- Record all relevant data related to the sorting process, including any deviations, maintenance activities, or calibrations.
- Ensure that all entries are clear, accurate, and signed by the respective personnel.
Abbreviations
No abbreviations are used in this SOP.
Documents
The following documents are referenced in this SOP:
- Manufacturing Instructions for Tablet Production
- Equipment Calibration Records
- Equipment Maintenance Records
References
No external references are used in this SOP.
SOP Version
This is version 1.0 of the SOP for Operation of Tablet Thickness Sorter, issued on [Date of Issue].