Operation and Maintenance of Suppository Labeling Machine
1) Purpose
The purpose of this SOP is to outline the procedures for operating and maintaining the suppository labeling machine to ensure accurate labeling of suppositories.
2) Scope
This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the suppository labeling machine in the manufacturing facility.
3) Responsibilities
It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the suppository labeling machine.
4) Procedure
4.1 Preparation
- Ensure the work area and equipment are clean and sanitized before starting the labeling process.
- Verify the availability and integrity of labeled suppositories ready for labeling.
- Inspect the suppository labeling machine, including label feeders and alignment mechanisms, to ensure they are clean and properly calibrated.
4.2 Labeling Process
- Set up the labeling parameters such as label position, alignment, and speed according to product specifications.
- Load the suppositories into the labeling machine and start the labeling process.
- Monitor the labeling process to ensure accurate placement of labels on suppositories.
4.3 Cleaning and Maintenance
- Stop the suppository labeling machine after completing the labeling batch.
- Clean the label feeders, labeling heads, and conveyor belts thoroughly to remove any adhesive residues.
- Perform preventive maintenance tasks such as lubricating moving parts and checking electronic components.
5) Abbreviations, if any
N/A
6) Documents, if any
Batch production record, Cleaning log, Suppository labeling specifications
7) Reference, if any
GMP guidelines, Manufacturer’s operating manual for suppository labeling machine
8) SOP Version
Version 1.0