Standard Operating Procedure for Aseptic Techniques during Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for maintaining aseptic conditions during pharmaceutical manufacturing processes to prevent contamination and ensure product quality.

2) Scope

This SOP applies to all personnel involved in aseptic manufacturing operations within the pharmaceutical facility.

3) Responsibilities

3.1 Production Operators

• Adhere to aseptic gowning and behavior requirements.
• Perform aseptic manipulations in accordance with SOPs and training.

3.2 Quality Assurance (QA) Personnel

• Verify compliance with aseptic techniques through visual inspections and environmental monitoring.
• Review and approve aseptic manufacturing records.

4) Procedure

4.1 Aseptic Gowning and Preparation

1. Perform hand hygiene and don appropriate sterile gowning attire.
2. Inspect gowning for integrity and proper fit before entering aseptic areas.

4.2 Environmental Monitoring

1. Conduct routine environmental monitoring of aseptic areas (e.g., air quality, surface microbial levels).
2. Take corrective actions for any deviations from acceptable environmental conditions.

4.3 Aseptic Manipulations

1. Handle sterile components and equipment with aseptic techniques.
2. Minimize open exposure of sterile products to the environment.

4.4 Cleaning and Disinfection

1. Clean and disinfect aseptic areas and equipment according to validated procedures.
2. Monitor effectiveness of cleaning and disinfection through routine testing.

5) Abbreviations, if any

QA: Quality Assurance

6) Documents, if any

• Aseptic Gowning Logs
• Environmental Monitoring Reports
• Cleaning and Disinfection Validation Records

7) Reference, if any

EU GMP Annex 1: Manufacture of Sterile Medicinal Products
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

8) SOP Version

Version 1.0