EN ISO 13408-3:2011 PDF
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 22
- Дата публикации:
- 29 июня 2011 г.
- Издание:
- CEN EN 13408 edition 2 version 1
- ICS:
- 11.080.01
ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.
Abstract
Overview
- Aseptic processing of health care products, Part 3: - is the CEN-adopted version of . The standard specifies requirements and provides guidance on equipment, processes, programmes and procedures for the control and . It is focused on microbiological and process control; it does address the physical or chemical objectives of a lyophilization cycle or formulation-specific drying goals.
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