ASTM E1838 - 17

Comprehensive Viral Filtration Testing with ASTM E1838-17

ASTM E1838-17, the Standard Test Method for Determining Viral Clearance in Viral Filtration Units, is an essential guideline for the pharmaceutical, biotech, and related industries. This standard provides a robust framework for evaluating the viral clearance performance of filtration units, ensuring the safety and efficacy of critical products and processes.

Ensuring Viral Clearance for Pharmaceutical and Biotech Applications

In the highly regulated pharmaceutical and biotech sectors, the ability to effectively remove and inactivate viruses is paramount. ASTM E1838-17 outlines the necessary procedures to:

• Determine the viral clearance capability of filtration units
• Validate the viral clearance performance of manufacturing processes
• Demonstrate compliance with regulatory requirements for viral safety

By adhering to the guidelines set forth in this standard, manufacturers can ensure the integrity of their products, protect patient safety, and maintain regulatory compliance.

Comprehensive Viral Filtration Testing Methodology

ASTM E1838-17 provides a detailed, step-by-step approach to viral filtration testing, covering the following key aspects:

• Test Virus Selection: The standard specifies the use of appropriate model viruses that are representative of the types of viruses that may be present in the manufacturing process.
• Challenge Preparation: Instructions are provided for the preparation of viral challenge solutions, ensuring consistent and reproducible test conditions.
• Filtration Process: The standard outlines the procedures for conducting the viral filtration process, including the use of appropriate equipment, flow rates, and sample collection methods.
• Viral Quantification: Detailed methods are described for the quantification of viral titers in both the challenge and filtrate samples, enabling the calculation of viral clearance factors.

Compliance and Regulatory Alignment

ASTM E1838-17 is aligned with the recommendations and guidelines set forth by regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). By adhering to this standard, manufacturers can demonstrate their commitment to product safety and quality, and ensure their processes meet the stringent requirements of the pharmaceutical and biotech industries.

Key Benefits of ASTM E1838-17

• Provides a standardized, reproducible method for evaluating viral clearance performance of filtration units
• Supports regulatory compliance and the validation of manufacturing processes
• Helps ensure the safety and efficacy of pharmaceutical and biotech products
• Promotes best practices in viral filtration and risk mitigation strategies
• Facilitates the development and improvement of viral clearance technologies

By implementing ASTM E1838-17, organizations in the pharmaceutical, biotech, and related industries can enhance their viral safety measures, optimize their manufacturing processes, and demonstrate their commitment to product quality and patient well-being.