Overview
ISO 13408-2:2018 - "Aseptic processing of health care products - Part 2: Sterilizing filtration" specifies requirements and guidance for sterilizing filtration as an integral element of aseptic processing performed in accordance with ISO 13408‑1. The standard covers setup, validation and routine operation of sterilizing filtration for liquids and gases used in health care products. It clarifies scope limits (not applicable to virus removal, HEPA filters, fluids intentionally containing particles larger than the filter pore size, or prion/removal processes).
Key topics and technical requirements
ISO 13408-2:2018 addresses the lifecycle of a sterilizing filtration process, including:
- Quality system elements - management responsibility, procurement of filters and documentation.
- Filter characterization - microbial removal effectiveness, material compatibility, and environmental considerations.
- Process and equipment characterization - risk management, process mapping and equipment qualification.
- Fluid definition and microbiological quality - understanding indigenous bioburden (e.g., Mycoplasma risks for biologics) and fluid-specific factors.
- Filter and process definition - selection, compatibility testing, filter use limits and filtration process parameters.
- Integrity testing - pre-use/post-use non-destructive tests and validation of integrity tests correlated to microbial retention.
- Validation - liquid and gas retention validation, aerosol retention for gases, filter sterilization validation, and validation of filter–fluid interactions.
- Routine monitoring and control - in-process controls, product release criteria and ongoing maintenance (recalibration, requalification, change control).
Important clarifications: microbial retention by filtration does not follow the same kinetic models as biocidal sterilization; therefore, the concept of SAL is not appropriate for filtration. The standard emphasizes establishing reproducible linkage between physical integrity test results and microbial retention.
Applications and users
ISO 13408-2:2018 is used by:
- Pharmaceutical, biopharmaceutical and biotechnology manufacturers (aseptic filling, biologics, cell-based therapies)
- Medical device and combination product manufacturers requiring sterilizing-grade filtration
- Filter suppliers, validation engineers, QA/QC and regulatory affairs professionals
- Contract manufacturing organizations (CMOs) implementing aseptic processing controls
Typical applications: sterile filtration of parenteral liquids, process gases for aseptic environments, and validation of sterilizing-grade filter systems in production and scale-up.
Related standards
- ISO 13408-1 (general aseptic processing)
- ISO 11139 (sterilization vocabulary)
- ISO 11135 and ISO 11137-1 (sterilization by ethylene oxide and radiation) - normative references for sterilization context
Keywords: ISO 13408-2:2018, sterilizing filtration, aseptic processing, filter validation, integrity testing, microbial retention, biopharmaceuticals, health care products.