ISO 13408-6:2005 PDF
Aseptic processing of health care products — Part 6: Isolator systems
Aseptic processing of health care products — Part 6: Isolator systems
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 17
- Дата публикации:
- 20 июня 2005 г.
- Издание:
- ISO IS 13408 edition 1 version 1
- ICS:
- 11.080.01
ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
Технические детали
- Технический комитет
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO 13408-6:2005
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