Standard Operating Procedure for Filling Machine Operation

1) Purpose

The purpose of this SOP is to outline the procedures for operating the filling machine to ensure accurate and sterile filling of injection products.

2) Scope

This SOP applies to all personnel involved in operating the filling machine at [Company Name] for the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Operators: Operating the filling machine according to the SOP.
– Maintenance Personnel: Ensuring the filling machine is in good working condition.
– Quality Assurance (QA) Department: Reviewing and approving filling machine operation procedures and records.

4) Procedure

4.1 Preparation for Filling
4.1.1 Ensure the filling machine and surrounding area are clean and disinfected.
4.1.2 Verify that the product to be filled has passed all preliminary quality control tests.
4.1.3 Ensure all materials (e.g., vials, stoppers) are sterilized and ready for use.
4.2 Filling Machine Setup
4.2.1 Set up the filling machine according to the manufacturer’s instructions.
4.2.2 Perform a pre-use check to ensure the machine is functioning correctly.
4.2.3 Calibrate the machine to ensure accurate fill volumes.
4.3 Filling Operation
4.3.1 Start the filling machine and monitor its operation.
4.3.2 Ensure vials are filled