ISO 13408-6:2021 Aseptic processing of health care products —Part 6: Isolator systems
标准简介
Aseptic processing of health care products —Part 6: Isolator systems由国际标准化组织于2021-04发布，适用于全球范围。标准截图
标准文档说明
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Aseptic processing of health care products —
Part 6: Isolator systems
1 Scope
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.
This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.
This document does not define biosafety containment requirements.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 13408-1:2008, Aseptic processing of health care products — Part 1: General requirements
ISO 13408-4, Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO 13408-7, Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration
ISO 14644-7, Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 18362, Manufacture of cell-based health care products — Control of microbial risks during processing
ISO/IEC 90003, Software engineering — Guidelines for the application of ISO 9001:2015 to computer software
ISO 11139, Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards
3 Terms a nd definiti ons
For the purposes of this document, the terms and definitions given in ISO 11139 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/ 3.1
ancillary isolator equipment
equipment that can be attached to or detached from the isolator whilst ensuring separation of the internal and external environment
3.2
bio-decontamination
removal and/or reduction of biological contaminants to an acceptable level
[SOURCE: ISO 11139:2018, 3.27]
3.3
decontamination device
means used to deliver the agent for the decontamination process
3.4
isolator
decontamination and where operators always remain separated from the interior of the enclosure by means of an absolute physical barrier
Note 1 to entry: If containment requirements apply (i.e. aseptic processing of hazardous materials) egress also has to be prevented.
[SOURCE: ISO 11139:2018, 3.149]
3.5
isolator system
isolator (3.4) with transfer system(s), and ancillary isolator equipment (3.1)
[SOURCE: ISO 11139:2018, 3.150]
3.6
safety data sheet
SDS
document specifying the properties of a substance, its potential hazardous effects for humans and the environment, and the precautions necessary to handle and dispose of the substance safely
[SOURCE: ISO 11139:2018, 3.239]
3.7
sterile barrier system
SBS
device acting as interface between the interiors of an isolator and ancillary isolator equipment (3.1) minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
3.8
transfer port
interface between the interior of an isolator (3.4) and ancillary isolator equipment (3.1)
Note 1 to entry: See example figures in Annex A.
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