YY/T 0567.2-2021Aseptic processing of health care products - Part 2: Sterilizing filtration (English PDF)

Foreword

YY/T 0567 "Aseptic Processing of Medical and Healthcare Products" consists of the following 7 parts.

---Part 1: General requirements;

---Part 2: Sterilization filtration;

---Part 3: Lyophilization;

---Part 4: Online cleaning technology;

---Part 5: Online sterilization;

---Part 6: Isolator system;

---Part 7: Alternative processing of medical devices and combined products. This part is part 2 of YY/T 0567.

This section was drafted in accordance with the rules given in GB/T 1.1-2009.

This part replaces YY/T 0567.2-2005 "Aseptic Processing of Medical Products Part 2: Filtration", and is compatible with YY/T 0567.2-2005 Compared with.2005, the main technical changes except for editorial changes are as follows.

--- Modify the "scope" (see Chapter 1, Chapter 1 of the.2005 edition);

---Modified the "normative references" (see Chapter 2, Chapter 2 of the.2005 edition);

---Modified the "bioburden" content in terms and definitions (see 3.2,.2005 edition 3.2), "chemical compatibility" content (see 3.3, The.2005 version of 3.3), "filter" content (see 3.5,.2005 version of 3.6), "fluid" content (see 3.6,.2005 version of the 3.12), the definition of "integrity test" is revised to "filter integrity test" and the content is revised (see 3.14 in the.2005 edition of 3.7);

--- Deleted "fiber" in terms and definitions (see 3.4 in the.2005 edition), "shedding fiber filter" (see 3.5 in the.2005 edition), "Filter assembly" (see 3.7 in the.2005 edition), "filter cartridge" (see 3.8 in the.2005 edition), "filter device" (see the.2005 edition 3.9), "filtration" (see 3.10 in the.2005 edition), "filtration system" (see 3.11 in the.2005 edition), "fluid sterilization filter" (see 3.13 in the.2005 edition), "nominal aperture ratio" (see 3.16 in the.2005 edition), "worst case" (see 3.17 in the.2005 edition);

---Added the terms and definitions of "extractable matter" (see 3.8), "pore size rating" (see 3.10), and "sterilization filtration" (see 3.11);

--- Deleted "General Requirements" (see Chapter 4 of the.2005 edition);

--- Added "Quality System Elements" (see Chapter 4);

--- Modified "Select filters and filter components based on the filter manufacturer's data" to "purchase filters" and "sterilize The filter characteristics are determined" and the content is expanded (see 4.3, Chapter 5, Chapter 5 of the.2005 edition);

--- Modified "The selection criteria for a specific fluid based on the data of the filter user" was changed to "Determination of process and equipment characteristics" and "The definition of fluid" (see Chapter 6, Chapter 7, Chapter 6 of the.2005 edition);

---Modified the "filtering process", changed to "process definition" and expanded the content (see Chapter 8, Chapter 7 of the.2005 edition);

---Modified "filter system design", changed to "confirm" and expanded the content (see Chapter 9, Chapter 8 of the.2005 edition);

---Modified "routine process", changed to "routine monitoring and control" and expanded the content (see Chapter 10, Chapter 9 of the.2005 edition);

--- Deleted the "process document" (see Chapter 10 of the.2005 edition), and put part of the relevant content in the standard body;

--- Added "Release of Sterilization Filter Products" (see Chapter 11);

--- Modified "Maintenance and Change Control", changed to "Maintain Process Effectiveness" and expanded the content (see Chapter 12, Chapter 12 of the.2005 edition Chapter 11);

--- Deleted "operator training" (see Chapter 12 of the.2005 edition), and put part of the relevant content in the standard text;

--- Deleted Appendix A "basic information and quality certification of the filter cartridge" (see Appendix A of the.2005 edition), and put part of the relevant content in the standard In the text;

---Added Appendix A "Guidelines for the Use of Standards" (see Appendix A).

This part uses the redrafting law to amend and adopt ISO 13408-2:2018 ``Aseptic Processing of Medical and Healthcare Products Part 2: Sterilization filter".

The technical differences between this part and ISO 13408-2:2018 and the reasons are as follows.

---The scope has been modified to suit my country's national conditions (see Chapter 1).

---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.

The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.

- Replace ISO 17665-1 with GB 18278.1 which is equivalent to adopting international standards (see 9.5.2);

- Replace ISO 11135 with equivalent medical device national standards GB 18279.1 and GB/T 18279.2 (see 9.5.2);

- Replace ISO 11137-1 with GB 18280.1 which is equivalent to adopting international standards (see 9.5.2);

- Replace ISO 11139 with GB/T.19971, which is equivalent to adopting international standards (see Chapter 3);

- Replace ISO 13485 with YY/T 0287 equivalent to the international standard (see 4.3 and 10.4);

- Replace ISO 13408-5 (see 9.5.2) with YY/T 0567.5 which is equivalent to the international standard.

--- Added the "Chinese Pharmacopoeia" in 7.2.2 to enhance the operability of this part in the field of production and quality supervision in my country. This section has made the following editorial changes.

---ISO 13408-2:2018 8.2.3.2a) "see 6.2.1d)" clerical error, corrected to "see 6.2.2d)".

Introduction

ISO 13408-1 specifies the basic requirements for aseptic processing. The aseptic processing process of healthcare products includes sterilization filtration, freezing Dry method, online cleaning technology, online sterilization, isolator system, alternative processing of medical equipment and combined products, etc., due to the complexity of the project.

Miscellaneous, cannot be fully specified by ISO 13408-1.Such specifications are regulated by the ISO 13408-2~ISO 13408-7 series of standards.

Sterilization filtration is a key step in the aseptic production process. The confirmation of the sterilization filtration process is very complicated, usually based on the process and product characteristics.

In a predetermined manner. This section describes the requirements, if met, will provide continuous removal of microorganisms from the fluid (liquid or gas) without affecting A sterile filtration process that negatively affects the quality of the filtrate. In addition, meeting this requirement ensures that the sterilization filtration process is reliable and reproducible To be able to reasonably determine that the sterile grade filter provides sterile filtrate under the specified operating conditions. This (reliability of the filtering process And repeatability) is very important, unlike the sterilization process where microorganisms can be inactivated, the process variables can be continuously monitored.

If in the process confirmation, a reproducible relationship is established between the product-specific bacteria retention capacity of the sterile grade filter and the physical integrity of the filter.

Complex relationship, use appropriate non-destructive pre-use and post-use filter integrity testing to determine whether the comprehensive The sterilization filtration process. The kinetics of inactivation during terminal sterilization follows mathematical theory and the sterility assurance level (SAL) can be calculated. used When the organisms in the fluid are filtered out, calculations cannot be carried out in accordance with this mathematical theory, so the term "sterile assurance level" cannot be used to describe Describe the use of filtered sterilization products.

Since the publication of the.2005 edition of this part, the development of biopharmaceuticals, biology-based medical devices, and cell-based healthcare products Development and usability have improved significantly. This edition emphasizes the importance of fully understanding the inherent bioburden properties of fluids that are sterilized by filtration Performance, including its relationship with the test microorganisms used to determine the microbial retention capacity of sterile-grade filters, for example, mycoplasma can be used in biological production The production of medicines, biotechnology, and cell-based healthcare products cause serious pollution. A comprehensive understanding of the inherent bioburden, Appropriate protective measures can be implemented during the development, confirmation and control of the sterilization filtration process to ensure the safety and safety of the filtered fluid. quality.

Although the activities required in this section have been grouped together and presented in a specific order, this section does not require that they be performed in the order presented. activity. The required activities are not necessarily continuous, because the development and validation procedures may be iterative. It is possible to execute these different chapters A number of individual individuals and/or organizations will be involved, and each individual and/or organization will undertake one or more of these activities. This section does not specifically say Identify the specific individual or organization carrying out the activity.

Refer to Appendix A for the application guide of this part.

The revision of this part will provide guidelines for the sterilization and filtration process of aseptic processing consistent with the requirements of international standards to ensure that the fluid (liquid Remove microorganisms from the body or gas) without negatively affecting the quality of the filtrate, so as to ensure that the sterilization filtration process is reliable and reproducible. Complex.

As a recommended industry standard, this part will serve as a beneficial supplement to the technical specifications of sterilization filtration, and provide enterprises with process and confirmation guidance. And provide technical guidance for supervisory agencies. Aseptic processing of healthcare products Part 2: Sterilization filtration

1 Scope

This part of YY/T 0567 specifies the terms and definitions of sterilization filtration, quality system elements, determination of sterilization filter characteristics, process and Equipment characterization, fluid definition, process definition, confirmation, routine monitoring and control, release of sterile filtration products and maintenance of process effectiveness.

This section applies to the establishment, confirmation and routine operation of the sterilization filtration process in the production of medical devices.

This section does not apply to the removal of viruses. Sterilization filtration is not suitable for fluids containing active ingredient particles larger than the Bacterial vaccine). This section does not apply to high-efficiency air filters (HEPA).

This section does not specify the process of removing spongiform encephalopathy, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease and other pathogens. Requirements for distribution, validation and routine control.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB 18278.1 Sterilization of Medical and Health Products Moisture Heat Part 1: Development, Validation and Routine Control Requirements for the Sterilization Process of Medical Devices Seek (GB 18278.1-2015, ISO 17665-1:2006, IDT)

GB 18279.1 Sterilization of medical and health care products ethylene oxide Part 1: Development, validation and routine control of the sterilization process of medical devices System requirements (GB 18279.1-2015, ISO 11135-1:2007, IDT)

GB/T 18279.2 Sterilization of Medical and Health Care Products Ethylene Oxide Part 2: GB 18279.1 Application Guide (GB/T 18279.2- 2015, ISO /T S11135-2.2008, IDT)

GB 18280.1 Sterilization radiation of medical and health care products Part 1: Development, validation and routine control requirements for the sterilization process of medical devices Seek (GB 18280.1-2015, ISO 11137-1.:2006, IDT)

GB/T.19971 Terminology for sterilization of healthcare products (GB/T.19971-2015, ISO /T S11139.2006, IDT)

YY/T 0287 Medical device quality management system for regulatory requirements (YY/T 0287-2017, ISO 13485:2016, IDT)

YY/T 0567.5 Aseptic processing of healthcare products Part 5: On-line sterilization (YY/T 0567.5-2011, ISO 13408- 5.2006, IDT)

ISO 13408-1:2008 Aseptic processing of health care products Part 1: General requirements (Asepticprocessingofhealth careproducts-Part 1: Generalrequirements)

ISO 13408-1:2008/Amd.1.2013 Aseptic processing of healthcare products Part 1: General requirements No. 1 amendment Single (Asepticprocessingofhealthcareproducts-Part 1: Generalrequirements-Amendment1)

3 Terms and definitions

The following terms and definitions defined in GB/T.19971 apply to this document.