Standard Operating Procedure for Aseptic Processing

1) Purpose

The purpose of this SOP is to establish procedures for aseptic processing to ensure that the manufacturing of injection products is performed in a sterile environment, preventing contamination.

2) Scope

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

3) Responsibilities

The responsibilities of this SOP include:
– Production Department: Conducting aseptic processing activities.
– Quality Control (QC) Department: Monitoring and testing to ensure sterility.
– Quality Assurance (QA) Department: Reviewing and approving aseptic processing procedures and records.

4) Procedure

4.1 Aseptic Area Preparation
4.1.1 Ensure that the aseptic processing area is clean and disinfected according to the cleaning SOP.
4.1.2 Verify that all equipment and materials are sterilized before entering the aseptic area.
4.2 Personnel Preparation
4.2.1 Ensure that all personnel have undergone proper gowning procedures as per the gowning SOP.
4.2.2 Perform hand hygiene before entering the aseptic processing area.
4.3 Aseptic Technique
4.3.1 Minimize movement and talking within the aseptic processing area to reduce contamination risk.
4.3.2 Use sterile tools and techniques for handling materials and equipment.
4.3.3 Perform all operations in a laminar airflow hood or cleanroom environment.
4.4