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YY/T 0567.6-2022: Aseptic processing of health care products - Part 6: Isolator systems
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Aseptic processing of health care products - Part 6: Isolator systems
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Basic data | Standard ID | YY/T 0567.6-2022 (YY/T0567.6-2022) | | Description (Translated English) | Aseptic processing of health care products - Part 6: Isolator systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 26,232 | | Date of Issue | 2022-08-17 | | Date of Implementation | 2024-03-01 | | Older Standard (superseded by this standard) | YY/T 0567.6-2011 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies requirements for isolator systems for aseptic processing of healthcare products, including aspects of specification, selection, qualification, biodecontamination, validation, operation, and control, and provides guidance. This standard applies to isolator systems used for aseptic processing of healthcare products. This standard does not specify requirements for Restricted Access Barrier Systems (RABS). This standard does not specify requirements for isolators for sterility testing, but some of the principles and information in this standard may also be applicable to related applications. This standard does not apply to biological security protection. | YY/T 0567.6-2022: Aseptic processing of health care products - Part 6: Isolator systems---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Aseptic processing of health care products -- Part 6.Isolator systems
ICS 11.080.01
CCSC47
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0567.6-2011
Aseptic processing of healthcare products
Part 6.Isolator Systems
(ISO 13408-6.2021, IDT)
Published on 2022-08-17
2024-03-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction V
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Quality System Elements 3
5 Isolator System Fundamentals 3
5.1 General 3
5.2 Negative pressure isolator 3
6 Isolator System Specifications 4
6.1 Overview 4
6.2 Risk management4
6.3 User Requirements Description 4
7 Isolator System Design 5
7.1 General requirements5
7.2 Materials of Construction 5
7.3 Air handling system 5
7.4 Operation interface 6
7.5 Isolator Auxiliary Equipment 7
7.6 Background Room Level 7
7.7 Utilities7
8 Confirm 8
8.1 General requirements8
8.2 Design qualification 8
8.3 Installation qualification 11
8.4 Run Qualification 11
8.5 Performance Qualification 12
8.6 Validation Review and Approval 13
8.7 Re-qualification 13
9 General monitoring 13
9.1 Procedure 13
9.2 System Integrity 13
9.3 Monitoring of biological decontamination process 13
9.4 Environmental Monitoring 14
9.5 Change Control 14
9.6 Maintenance and calibration 14
10 Personnel training14
Appendix A (Informative) Apparatus for Ports for Portable Portable Equipment 15
Appendix B (Informative) Isolator Systems --- Interpretation of Terms and Air Material Flow 17
Appendix C (Informative) Isolator System --- Product Direct/Indirect Contact Surface 18
Reference 19
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document is part 6 of YY/T 0567 "Aseptic Processing of Healthcare Products". YY/T 0567 has issued the following parts.
--- Part 1.General requirements;
--- Part 2.Sterile filtration;
--- Part 3.Freeze-drying;
--- Part 4.In-line cleaning technology;
--- Part 5.In-line sterilization;
--- Part 6.Isolator systems;
--- Part 7.Alternative processing of medical devices and combination products.
This document replaces YY/T 0567.6-2011 "Aseptic processing of healthcare products - Part 6.Isolator systems", and
Compared with YY/T 0567.6-2011, in addition to structural adjustment and editorial changes, the main technical changes are as follows.
--- Changed the scope of the document (see Chapter 1, Chapter 1 of the.2011 edition);
--- Added the terms and definitions of "isolator auxiliary equipment" and "sterile barrier system" (see 3.1 and 3.7);
--- Deleted the "design qualification", "leak test", "risk assessment", "isolation device", "surrounding environment", "transfer device" and "worst case condition".
terms and definitions (see 3.2, 3.5, 3.7, 3.8, 3.9, 3.10 and 3.13 of the.2011 edition);
--- Changed the terms and definitions of "Isolator", "Safety Data Sheet" and "Transmission System" (see 3.4, 3.6, 3.9,.2011 edition of
3.3, 3.6, 3.12);
--- Changed the quality system elements of the document (see Chapter 4, Chapter 4 of the.2011 edition);
--- Added "Basic Principles of Isolator System" chapter (see Chapter 5);
--- Added the chapter "Isolator System Specifications" (see Chapter 6);
--- Delete the relevant provisions of "category of isolators" (see 5.2 of the.2011 edition);
--- Changed the relevant provisions of the isolator "structural material" (see 7.2, 5.3 of the.2011 edition);
--- Added the relevant overview of the air handling system (see 7.3.1)
--- Changed the relevant provisions of "ventilation rate" (see 7.3.2, 5.4.1 of the.2011 edition);
--- Changed the relevant provisions of "airflow model" (see 7.3.3, 5.4.2 of the.2011 edition);
--- Changed the relevant provisions of "temperature/humidity" (see 7.3.4, 5.4.3 of the.2011 edition);
--- Changed the relevant provisions of "recirculation of air" (see 7.3.6, 5.4.5 of the.2011 edition);
--- Changed the relevant provisions of the pressure difference between the components of the isolator system and (or) between the components and the external environment (see 7.3.7,
5.4.6 of the.2011 version);
--- Delete the relevant provisions of "filter maintenance" (see 5.4.7 of the.2011 edition);
--- Changed the relevant regulations for the design of isolator gloves and sleeves (see 7.4.1.1, 5.5.1.1 of the.2011 edition);
--- Changed the relevant provisions of the material in and out of the isolator (see 7.4.3, 5.5.3 of the.2011 edition);
--- Changed the relevant provisions of the transfer port (see 7.4.4, 5.6.2 of the.2011 edition);
--- Changed the relevant provisions of waste container design (see 7.5.1.2, 5.6.1.2 of the.2011 edition);
--- Changed the relevant provisions of the background room where the isolator system is installed (see 7.6, 6.1 of the.2011 edition);
--- Changed the relevant provisions of public facilities connected to the isolator (see 7.7, 6.2 of the.2011 edition);
--- Changed the relevant provisions of the design confirmation of the isolator system (see 8.2.1, 8.2 of the.2011 edition);
--- Change the relevant provisions of online cleaning and manual cleaning (see 8.2.4.2, 8.2.4.3, 7.3.2 and 7.3.3 of the.2011 edition);
--- Changed the relevant provisions of biological decontamination and selection of biological decontamination agents (see 8.2.5, 8.2.6, 8.2.7, 8.2.8, 8.2.9, 8.2.10,
8.2.11, 8.2.12, 7.4 of the.2011 edition);
--- Added relevant provisions for the development and verification of the sterilization process (see 8.2.13);
--- Delete the relevant provisions of the power supply when the installation qualification is interrupted [8.3.2n) of the.2011 edition];
--- Changed the relevant regulations for the performance confirmation of the isolator system (see 8.5, 8.5 of the.2011 edition);
--- Increase the relevant provisions if biological indicators (BI) or chemical indicators (CI) are used in the revalidation process (see 8.7.4);
--- Changed the relevant provisions of the isolator system integrity (see 9.2, 9.2 of the.2011 edition);
--- Changed the relevant provisions of biological decontamination process monitoring (see 9.3, 9.3 of the.2011 edition);
--- Changed the relevant provisions of environmental monitoring (see 9.4, 9.4 of the.2011 edition);
--- Changed the relevant provisions of maintenance and calibration (see 9.6, 9.6 of the.2011 edition);
--- Changed the relevant provisions of personnel training (see Chapter 10, Chapter 10 of the.2011 edition).
This document is equivalent to ISO 13408-6.2021 "Aseptic processing of healthcare products - Part 6.Isolator systems".
The following minimal editorial changes have been made to this document.
--- Added reference to Appendix C in Note 3 of 5.1.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Standardization Technical Committee of Disinfection Technology and Equipment (SAC/TC200).
This document is drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Zhejiang Tailin Biotechnology Co., Ltd., Shandong Xinhua Medical
Medical Devices Co., Ltd., Johnson & Johnson (Suzhou) Medical Devices Co., Ltd.
The main drafters of this document. Zhu Pengzhi, Shou Minhang, Li Xiaoming, Liu Xuemei, Liao Huier, He Zhuohua, Xia Xiaojiu, Zhao Zhenbo, Zhao Jia,
Ding Hongyong.
The previous versions of this document and its superseded documents are as follows.
---First published in.2011 as YY/T 0567-2011;
---This is the first revision.
Introduction
Healthcare products identified as "sterile" are manufactured using rationally designed, validated and controlled methods. If possible, the product is
It is terminally sterilized in its final sealed package. If terminal sterilization is not possible, then the product is aseptically processed.
Aseptic processing is a rigorous process that ensures that all stages of pre-processing, production, filling and final package sealing remain free of
Bacterial status. The process relies on many independent factors to prevent re-introduction of contamination into the product mix or filling into the process.
An effective risk management system addresses the design (including the use of barrier separation techniques), validation and control of aseptic processing,
and can identify, assess, eliminate (where applicable) and control the risk of contamination that provides the necessary sterility assurance for aseptically processed products
condition.
A variety of isolation systems are used to protect critical processing areas in aseptic processing areas from particulate and microbial contamination, and
Isolate operators from critical processing areas.
Such isolation systems include controlled airflow devices based on pneumatic protection, and isolation barriers that combine physical and pneumatic protection to
The external cleanroom environment is isolated from critical processing areas, minimizing operator contact in this area and reducing processing
pollution opportunities.
The isolator system provides both physical isolation and at the same time facilitates the operator in isolation (usually through gloves on the isolator barrier).
mouth-attached glove-sleeve system) to operate in a controlled processing environment. To establish a controlled environment, generally through a confirmed, reproducible
cleaning and biodecontamination process to remove microorganisms or particulate matter within the isolator. This process is mainly achieved by using automated methods.
In addition to the control of microorganisms and particulate matter, the isolator system can also integrate other control functions, which in combination with its operating specifications are
The product provides an isolated environment to prevent cross-contamination of process contaminants and product batches, and to control the impact on operators.
risk.
Aseptic processing of healthcare products
Part 6.Isolator Systems
1 Scope
This document specifies requirements for isolator systems for aseptic processing of healthcare products, including specification, selection, qualification, biological decontamination,
Identify, operate and control aspects, and provide relevant guidance.
This document applies to isolator systems for aseptic processing of healthcare products.
This document does not specify requirements for Restricted Access Barrier Systems (RABS).
This document does not specify requirements for sterility check isolators, but some of the principles and information in this document may also be applicable to related applications.
This document does not apply to biosafety protection.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
ISO 11139.2018 Glossary of terms used in the standard for sterilization of healthcare products and related equipment and processes
andprocessstandards)
Note. GB/T.19971-2015 Terminology for Sterilization of Healthcare Products (ISO /T S11139.2006, IDT)
careproducts-Part 1.Generalrequirements)
Note. YY/T 0567.1-2013 Aseptic Processing of Healthcare Products Part 1.General Requirements (ISO 13408-1.2008, IDT)
careproducts-Part 4.Clean-in-placetechnologies)
Note. YY/T 0567.4-2011 Aseptic processing of healthcare products - Part 4.In-line cleaning technology (ISO 13408-4.2005, IDT)
ISO 13408-7 Aseptic processing of healthcare products - Part 7.Alternative processing of medical devices and combination products
products)
Note. YY/T 0567.7-2016 Aseptic Processing of Healthcare Products Part 7.Alternative Processing of Medical Devices and Combination Products (ISO 13408-
7.2012, IDT)
Note. GB/T 25915.1-2010 Cleanrooms and Related Controlled Environments Part 1.Air Cleanliness Classes (ISO 14644-1.1999, IDT)
ISO 14644-7 Cleanrooms and related controlled environments Part 7.Isolation devices (clean hoods, glove boxes, isolators, microenvironments)
gloveboxes, isolators and mini-environments)]
Note. GB/T 25915.7-2010 Cleanrooms and related controlled environments Part 7.Isolation devices (clean hoods, glove boxes, isolators, microenvironments)
(ISO 14644-7.2004, IDT)
ISO 18362 Microbiological risk control during the production and processing of cell-based healthcare products (Manufactureofcel-
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