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 Environmental Monitoring
4.4.1 Conduct environmental monitoring during aseptic processing to detect any potential contamination.
4.4.2 Record environmental monitoring results and compare them with established acceptance criteria.
4.4.3 If contamination is detected, halt processing, investigate the cause, and implement corrective actions.
4.5 Quality Control Testing
4.5.1 Take samples of the product during and after aseptic processing for quality control testing.
4.5.2 Perform tests to verify that the product meets sterility and quality criteria.
4.5.3 Record test results and compare them with established acceptance criteria.
4.5.4 If the product fails to meet quality criteria, investigate the cause and take corrective actions.
4.6 Documentation
4.6.1 Maintain records of all aseptic processing steps, environmental monitoring results, and quality control test results.
4.6.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Environmental Monitoring Records
– Quality Control Test Records

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0