Operation and Maintenance of Suppository Filling and Sealing Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository filling and sealing machine to ensure the production of high-quality suppositories.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the filling and sealing process.
2. Verify the availability and integrity of suppository shells and filling materials required for the batch.
3. Inspect the filling and sealing machine to ensure it is clean, calibrated, and ready for use.

4.2 Filling Process

1. Set up the filling parameters (volume, speed) according to the suppository formulation specifications.
2. Load the suppository shells into the machine and fill them with the specified medicated or non-medicated formulation.
3. Monitor the filling process to ensure accurate filling and minimize wastage.

4.3 Sealing and Packaging

1. Seal the filled suppositories using the machine’s sealing mechanism, ensuring proper closure and integrity.
2. Inspect sealed suppositories for any defects or irregularities.
3. Transfer the sealed suppositories to the packaging area for labeling and batch coding.

4.4 Cleaning and Maintenance

1. Stop the filling and sealing machine after completing the batch.
2. Disassemble the filling and sealing components for thorough cleaning and sanitation.
3. Perform routine maintenance tasks such as lubrication and inspection of parts.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Formulation record

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for suppository filling and sealing machine

8) SOP Version

Version 1.0