DIN EN ISO 13408-7 2015-11 PDF

Full title and description

DIN EN ISO 13408-7:2015-11 — Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products. (German version of EN ISO 13408-7:2015, based on ISO 13408-7:2012.) Specifies requirements and guidance for alternative process-simulation approaches and a risk-based framework to design, qualify and requalify aseptic processes for medical devices and combination products that cannot be terminally sterilized and where conventional media-fill methods are not applicable.

Abstract

This standard provides requirements and guidance for demonstrating aseptic processing and sterility assurance when a direct substitution of product by microbiological growth medium (media-fill) is not feasible or would not adequately simulate the true process. It describes a risk-based methodology to design alternative process simulations, define acceptance criteria, perform qualification and requalification, and document controls for environmental, personnel and process factors to support sterility claims for medical devices and combination products processed aseptically.

General information

• Status: Published (DIN national adoption of EN ISO 13408-7; harmonized European adoption).
• Publication date: 2015-11 (DIN publication/adoption: 01 November 2015; original ISO edition published August 2012).
• Publisher: DIN (Deutsches Institut für Normung e. V.) — German version of EN ISO 13408-7:2015 (based on ISO 13408-7:2012).
• ICS / categories: 11.080.01 — Sterilization and disinfection in general.
• Edition / version: DIN EN ISO 13408-7:2015-11 (German version of EN ISO 13408-7:2015; based on ISO 13408-7:2012, Edition 1).
• Number of pages: 38 (German/EN national publication format).

Scope

Defines requirements and gives guidance for alternative approaches to process simulation and validation of aseptic processing where terminal sterilization is not possible and a standard media-fill approach (as described in ISO 13408-1) is not practicable. The standard addresses the use of formal risk assessment to determine suitable surrogate tests or simulation strategies, design of studies to challenge the process, qualification and requalification intervals, and the controls and documentation needed to demonstrate sterility assurance for medical devices and combination products.

Key topics and requirements

• Risk-based design of process simulation studies when media-fill substitution is not feasible.
• Identification and justification of suitable surrogates and alternative contamination challenges.
• Requirements for process qualification, requalification and ongoing monitoring.
• Environmental and personnel controls relevant to aseptic processing validation.
• Definition of acceptance criteria and interpretation of simulation results.
• Documentation, traceability and reporting necessary to support sterility claims.
• Integration with quality systems and with related sterilization and device-processing standards.

Typical use and users

Used by medical device and combination-product manufacturers, validation and quality assurance engineers, regulatory affairs professionals, contract manufacturing organizations and sterilization/aseptic-process specialists. It is applied during development and qualification of aseptic manufacturing processes, design transfers, regulatory submissions and internal/external audits where terminal sterilization is not an option.

Related standards

ISO 13408 series (Parts 1–6), ISO 14937, ISO 17664, ISO 11607 (packaging for terminally sterilized products), ISO/TS guidance on sterilization and process validation, and applicable EN/CEN guidance for sterile medical device manufacture. National adoptions and the EN adoption (EN ISO 13408-7:2015) provide the harmonized European context for regulatory compliance.

Keywords

aseptic processing; alternative process simulation; media-fill; process validation; sterility assurance; medical devices; combination products; risk assessment; qualification; requalification; environmental control; personnel; acceptance criteria.

FAQ

Q: What is this standard?

A: It is the German national adoption (DIN EN ISO 13408-7:2015-11) of EN ISO 13408-7, titled "Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products," providing requirements and guidance for alternative aseptic process simulations.

Q: What does it cover?

A: It covers the design, justification and execution of alternative process simulations and validation activities when conventional media-fill approaches are not applicable, using a risk-based approach to demonstrate and maintain sterility assurance for medical devices and combination products manufactured aseptically.

Q: Who typically uses it?

A: Medical device manufacturers, contract manufacturers, validation engineers, QA/RA teams and regulators involved in sterile process qualification where terminal sterilization cannot be used.

Q: Is it current or superseded?

A: The ISO parent document (ISO 13408-7:2012) is the edition on which EN ISO 13408-7:2015 is based. The DIN adoption date is November 2015. Users should confirm the status of the ISO/EN/DIN versions in their national catalogues for any later amendments or revisions; as published in national form this 2015 German version is the national adoption of the EN/ISO text.

Q: Is it part of a series?

A: Yes — it is part 7 of the ISO 13408 series (Aseptic processing of health care products). The series also includes Part 1 (general requirements) and other parts addressing sterilizing filtration, sterilization-in-place, clean-in-place and related topics.

Q: What are the key keywords?

A: Aseptic processing, alternative process simulation, media-fill, sterility assurance, risk assessment, validation, medical devices, combination products.