Standard Operating Procedure for Tablet Press Calibration and Adjustment
Purpose:
The purpose of this SOP is to establish guidelines for the calibration and adjustment of tablet press machines within the tablet manufacturing department. This SOP aims to ensure the accuracy, reliability, and consistency of tablet press equipment, thereby promoting product quality, adherence to dosage specifications, and compliance with regulatory requirements and Good Manufacturing Practices (GMP).
Scope:
This SOP applies to all personnel involved in the calibration and adjustment activities of tablet press machines in the tablet manufacturing department.
Responsibilities:
3.1. Production Supervisor:
Ensure that tablet press operators are trained and qualified to perform the calibration and adjustment tasks outlined in this SOP.
Verify that tablet press calibration and adjustment activities are performed as per the defined procedures.
Monitor compliance with safety regulations and GMP during tablet press calibration and adjustment.
3.2. Tablet Press Operator:
Perform calibration and adjustment tasks on the tablet press machine as outlined in this SOP.
Follow safety guidelines and wear appropriate personal protective equipment (PPE) during tablet press calibration and adjustment.
Report any abnormalities, equipment malfunctions, or calibration issues to the Production Supervisor.
Procedure:
4.1. Calibration Preparations:
a. Gather the necessary calibration tools, reference standards, and documentation required for the calibration process.
b. Ensure that the tablet press machine is turned off, locked out, and at ambient conditions before initiating the calibration.
4.2. Tablet Press Calibration:
a. Identify the critical parameters to be calibrated on the tablet press machine, such as compression force, tablet weight, or tablet thickness.
b. Follow the tablet press machine manufacturer’s guidelines or SOPs for specific calibration procedures.
c. Perform calibration adjustments using appropriate calibration tools, ensuring accuracy and traceability of measurements.
d. Document the calibration results, including the initial values, adjustments made, and final values, in the calibration records or logbooks.
e. Verify that the calibration results fall within acceptable limits and meet the specified requirements for the tablet press machine.
4.3. Tablet Press Adjustment:
a. Identify the parameters or settings on the tablet press machine that require adjustment, such as fill depth or turret speed.
b. Follow the tablet press machine manufacturer’s guidelines or SOPs for specific adjustment procedures.
c. Make necessary adjustments to the tablet press machine, ensuring proper alignment and adherence to dosage specifications.
d. Document the adjustment details, including the parameters adjusted, the adjustments made, and any associated observations or measurements.
e. Verify that the adjusted parameters meet the specified requirements and dosage specifications for the tablet press machine.
Abbreviations:
N/A: Not Applicable
Documents:
a. Tablet press machine manual
b. Calibration standards and reference materials
c. Calibration records or logbooks
Reference:
[Insert reference if applicable]
Revision History:
Version 1.0: [Insert Date] – Initial version of the SOP
This SOP provides clear guidelines for the calibration and adjustment of tablet press machines in the tablet manufacturing department. It ensures that the equipment is calibrated accurately, adjusted appropriately, and complies with regulatory requirements, leading to consistent and accurate tablet production.