SIST EN ISO 13408-2:2018 PDF

Overview

EN ISO 13408-2:2018 - "Aseptic processing of health care products - Part 2: Sterilizing filtration" specifies requirements and guidance for the use of sterilizing filtration within aseptic processing of health care products when used together with ISO 13408‑1. Published as a CEN-endorsed European Standard in 2018, it focuses on requirements for the set‑up, validation and routine operation of sterilizing filtration processes used to achieve or maintain product sterility.

Important exclusions:

• Not applicable to virus removal (the standard does not cover processes intended to remove viruses).
• Not applicable to fluids intentionally containing particles larger than the filter pore size (e.g., whole-cell bacterial vaccines).
• HEPA filters are excluded (standard does not apply to HEPA air filtration).
• Does not cover removal of agents of spongiform encephalopathies (specific national guidance exists for these agents).

Key topics and requirements

EN ISO 13408-2:2018 addresses practical and quality-oriented aspects of sterilizing filtration, including:

• Quality system elements and management responsibility for filtration processes.
• General requirements for filter set‑up, selection and installation to support aseptic processing.
• Validation principles for demonstrating that a sterilizing filtration process consistently achieves required sterility assurance.
• Routine operation and control - monitoring, documentation and maintenance needed to sustain validated performance.
• Guidance for filter users on process design, acceptance criteria and ongoing verification activities.

The standard is intended to be used in conjunction with ISO 13408‑1 and other normative references to create a comprehensive aseptic processing control strategy.

Applications and practical value

EN ISO 13408-2:2018 is valuable for organizations that use sterilizing filtration as part of aseptic manufacturing of sterile pharmaceuticals, biologics, diagnostic reagents and medical device liquids. Practical applications include:

• Designing and qualifying sterile filtration steps in drug and biologics production
• Developing validation protocols and acceptance criteria for sterilizing filters
• Establishing routine monitoring, change control and maintenance procedures for filtration operations
• Integrating filtration controls into an overall aseptic processing quality system

Who should use this standard

• Quality assurance and regulatory affairs professionals in pharmaceutical and biotech manufacturing
• Process engineers and validation specialists responsible for filtration steps
• Manufacturers of sterile health care products, contract manufacturing organizations (CMOs), and filter end‑users
• Auditors and compliance teams assessing aseptic processing controls

Related standards

• ISO 13408‑1 (Aseptic processing - general requirements)
• Other referenced sterilization and quality standards (see normative references in EN ISO 13408‑2)

Using EN ISO 13408-2:2018 helps organizations align sterilizing filtration practices with international guidance for aseptic processing, improving sterility assurance, regulatory readiness and process robustness.