Standard Operating Procedure for Tablet Press Operation and Changeover
Purpose:
The purpose of this SOP is to establish guidelines for the safe and efficient operation and changeover of tablet press machines within the tablet manufacturing department. This SOP aims to ensure product quality, minimize downtime, and promote compliance with regulatory requirements and Good Manufacturing Practices (GMP).
Scope:
This SOP applies to all personnel involved in the operation, maintenance, and changeover 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 tasks outlined in this SOP.
Verify that tablet press operation and changeover activities are performed as per the defined procedures.
Monitor compliance with safety regulations and GMP during tablet press operation and changeover.
3.2. Tablet Press Operator:
Operate tablet press machines as per the documented procedures.
Perform routine inspections, cleaning, and maintenance tasks as outlined in this SOP.
Follow safety guidelines and wear appropriate personal protective equipment (PPE) during tablet press operation and changeover.
Procedure:
4.1. Pre-Operation Preparation:
a. Obtain the batch record and review it for accuracy and completeness.
b. Verify that the tablet press machine is clean, properly assembled, and in good working condition.
c. Check the availability and suitability of required tools, machine parts, and tablet press components.
4.2. Tablet Press Operation:
a. Set the tablet press machine parameters as per the batch record instructions, including tablet size, weight, and compression force.
b. Load the appropriate tooling, punches, and dies into the tablet press machine.
c. Start the tablet press machine and ensure that it operates within the specified parameters.
d. Monitor tablet press operation for uniform tablet weight, quality, and any abnormal issues.
e. Perform in-process checks and sampling as per the batch record requirements.
f. Document all relevant information and observations in the batch record and logbooks.
4.3. Tablet Press Changeover:
a. Follow the documented changeover procedure provided by the equipment manufacturer or approved by the company.
b. Ensure that the tablet press machine is stopped and locked out before proceeding with the changeover process.
c. Remove the tooling, punches, and dies from the tablet press machine, and clean them thoroughly.
d. Clean the tablet press machine surfaces, hoppers, and feeders using approved cleaning agents and procedures.
e. Install the new tooling, punches, and dies required for the next product or batch.
f. Perform necessary adjustments, calibrations, and test runs to ensure proper functioning and alignment of the tablet press machine.
g. Document all changeover activities, including cleaning, adjustments, and inspections, in the relevant logbooks and records.
Abbreviations:
N/A: Not Applicable
Documents:
a. Batch record
b. Tablet press machine manual
c. Changeover procedure
Reference:
[Insert reference if applicable]
Revision History:
Version 1.0: [Insert Date] – Initial version of the SOP
This SOP provides clear guidelines for the operation and changeover of tablet press machines in the tablet manufacturing department. It ensures that the equipment is used in a controlled manner and that changeover processes are carried out efficiently and in compliance with quality and safety standards.