Operation and Maintenance of Suppository Trimming Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository trimming machine to ensure accurate and efficient trimming of suppositories.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the suppository trimming 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 trimming machine.

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the trimming process.
2. Verify the availability and integrity of suppositories ready for trimming.
3. Inspect the suppository trimming machine, including cutting blades and conveyor systems, to ensure they are clean and operational.

4.2 Trimming Process

1. Set up the trimming parameters such as trimming speed, cut length, and precision according to product specifications.
2. Load the suppositories onto the trimming line and start the trimming process.
3. Monitor the trimming process to ensure consistent and precise trimming of suppositories.

4.3 Cleaning and Maintenance

1. Stop the suppository trimming machine after completing the trimming batch.
2. Clean the cutting blades, conveyor systems, and trimming area thoroughly to remove any residue.
3. Perform routine maintenance tasks such as sharpening of cutting blades and inspection of conveyor belts.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for suppository trimming machine

8) SOP Version

Version 1.0