ISO 13408-3:2006
Aseptic processing of health care products — Part 3: Lyophilization
Aseptic processing of health care products — Part 3: Lyophilization
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 11
- Дата публикации:
- 1 сентября 2006 г.
- Издание:
- ISO IS 13408 edition 1 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
ISO 13408-3:2006 - "Aseptic processing of health care products - Part 3: Lyophilization" provides requirements and guidance for controlling and validating lyophilization (freeze-drying) when performed as an aseptic process. The standard covers equipment, processes, programmes and procedures needed to protect product sterility and quality during lyophilization, but it does address the physical or chemical objectives of a lyophilization cycle (e.g., formulation-specific drying endpoints).
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