SIST EN ISO 13408-1:2024 PDF

Name: SIST EN ISO 13408-1:2024 — Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
SKU: SIST EN ISO 13408-1:2024
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Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

Название (английский):

SIST EN ISO 13408-1:2024

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 91
Дата публикации:: 14 мая 2024 г.
Издание:: ISO 13408-1:2023
ICS:: 11.080.01

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Описание (английский):

This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 13408-1:2024 (ISO 13408-1:2023) specifies the general requirements and guidance for the development, validation and routine control of aseptic processing of health care products. Published by CEN as the European adoption of ISO 13408-1, this standard sets out high‑level expectations for processes, programs and procedures used to maintain aseptic conditions during manufacture of sterile medicines, medical devices and other health care products.

Key topics and requirements

Scope and intent: General requirements and guidance for aseptic processing; not a replacement for product‑specific manufacturing controls.

Process development: Framework for planning aseptic processes, including risk‑based approaches and procedural controls.

Validation: Guidance on establishing and documenting validated aseptic processes prior to routine production.

Routine control and monitoring: Expectations for ongoing environmental, personnel and process monitoring to maintain sterility assurance.

Programs and procedures: Organization of standard operating procedures (SOPs), training, change control and quality oversight for aseptic operations.

Interface to specialist methods: Identifies that sterilizing filtration, lyophilization, clean‑in‑place (CIP), sterilization‑in‑place (SIP) and isolator systems are covered in other parts of the ISO 13408 series (e.g., Part 2, Part 6).

Regulatory linkage: Assists conformity with EU Regulations (e.g., Regulation (EU) 2017/745 and 2017/746) for applicable General Safety and Performance Requirements where aseptic processing is relevant.

Applications and who should use it

This standard is essential for:

Pharmaceutical and biotech manufacturers implementing or improving aseptic filling and sterile product assembly.

Medical device manufacturers producing devices requiring aseptic handling or sterile assembly.

Quality assurance, validation and regulatory teams developing validation protocols, routine monitoring plans and compliance documentation.

Facility design and operations teams aligning cleanroom practice, personnel flows and environmental control with aseptic requirements. Use cases include process design, validation planning, writing SOPs for aseptic operations, and establishing monitoring programs to sustain sterility assurance during production.

Related standards

ISO 13408-2 (Sterilizing filtration)

ISO 13408-6 (Isolator systems)

ISO 14644 series (Cleanrooms and associated controlled environments - notably Parts 1, 2, 4 and 7) These referenced standards provide the detailed technical requirements for specific methods, cleanroom classification and separative devices that complement the general guidance in EN ISO 13408-1.

Keywords: aseptic processing, health care products, ISO 13408-1, EN ISO 13408-1:2024, validation, sterilizing filtration, lyophilization, CIP, SIP, isolator systems, cleanrooms, regulatory compliance.

SIST EN ISO 13408-1:2024 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and who should use it

Related standards

Технические детали

ISO 13408-1:2023

Aseptic processing of health care products — Part 1: General requirements

BS EN ISO 13408-1:2024

Aseptic processing of health care products. General requirements.

BS EN ISO 13408-3:2011

Aseptic processing of health care products. Lyophilization.

BS EN ISO 13408-2:2018

Aseptic processing of health care products. Sterilizing filtration.

SIST EN ISO 13408-6:2021

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

BS EN ISO 14644-13:2026

Cleanrooms and associated controlled environments. Cleaning of surfaces to achieve defined levels of cleanlin…