Sterilization, Cleanrooms and Packaging
ISO 13408: Aseptic Processing of Health Care Products
ISO 13408 covers aseptic processing of health care products: producing sterile product from sterile components under controlled conditions, rather than sterilizing it in its final container. Its general part sets the overall requirements, and further parts address specific technologies used in aseptic operations.
At a Glance
- Standard
- ISO 13408
- Subject
- Aseptic Processing of Health Care Products
- Group
- Sterilization, Cleanrooms and Packaging
- Industries
- 1 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
Aseptic processing is used when a product or its contents can't withstand terminal sterilization. The general requirements cover the whole operation: contamination risk management, facility and environmental control, personnel training and gowning, sterilization of components and equipment, and the process simulation that shows the aseptic process can produce sterile product.
Other parts go deeper on specific elements, such as sterilizing filtration, lyophilization, clean in place and sterilization in place, and isolator systems. Each addresses how that technology is validated and controlled within an aseptic process.
Process simulation, often called a media fill, is the centerpiece of validation: growth medium runs through the process, including worst-case interventions, to show the process doesn't introduce contamination. Because aseptic assurance depends heavily on people and environment, ongoing environmental monitoring and control of interventions matter as much as the initial validation.
Who It Applies To
- Makers of devices or combination products filled or assembled aseptically
- Manufacturers of liquid, biologic or drug components that can't be terminally sterilized
- Contract fill and finish operations serving device makers
- Sites using isolators or sterilizing filtration
What Auditors Check
Process Simulations
Media fill design, frequency, worst-case interventions, participants and results, with investigations of any contaminated units.
Environmental Monitoring
A monitoring program with defined locations, alert and action levels, trending and documented responses to excursions.
Personnel Qualification
Gowning qualification and aseptic technique training, with each operator covered by process simulation.
Intervention Control
A defined list of permitted interventions and records of the interventions made during production.
Sterilization of What Enters
Validated sterilization of everything entering the aseptic zone, including filters and product contact parts.
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Industry Guides That Reference ISO 13408
ISO 13408
Check Your Quality System Against ISO 13408
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