YY/T 1268-2023 PDF English
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Product adoption and process equivalence for ethylene oxide sterilization
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YY/T 1268-2023: Product adoption and process equivalence for ethylene oxide sterilization---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1268-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.080.01
CCS C 47
Replacing YY/T 1268-2015
Product adoption and process equivalence for ethylene oxide
sterilization
Issued on. MARCH 14, 2023
Implemented on. MAY 01, 2024
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 5
4 Product adoption... 7
5 Process equivalence... 11
Annex A (informative) Guidelines for the evaluation of product adoption to EO product
family or EO processing category... 17
Annex B (informative) Guidelines for process equivalence evaluation... 20
Bibliography... 22
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020
"Directives for standardization - Part 1.Rules for the structure and drafting of
standardizing documents".
This document replaces YY/T 1268-2015 "Product adoption and process equivalence
for ethylene oxide sterilization". Compared with YY/T 1268-2015, in addition to
structural adjustments and editorial changes, the main technical changes are as follows.
a) Changed the scope statement (see Chapter 1 of this Edition; Chapter 1 of Edition
2015);
b) Changed the terms and definitions of "candidate equipment", "candidate product",
"EO processing category", "EO product family", "load configuration", "process
equivalence", "product adoption", "requalification", "sterilization process
equipment" and "sterilization specialist" (see 3.1~3.5, 3.7~3.11 of this Edition;
3.1~3.10 of Edition 2015);
c) Added the term and definition "packaging system" (see 3.6 of this Edition);
d) Changed the additional notes for products in Chapter 4 to general provisions (see
4.1 of this Edition; Notes for Chapter 4 of Edition 2015);
e) Changed the contents of product family and processing category (see 4.2 of this
Edition; 4.1 and 4.2 of Edition 2015);
f) Changed the mandatory clauses to recommended clauses (see 4.2, 4.3, 4.5, 4.7,
5.9 of this Edition; 4.2, 4.3.2, 4.3.4, 4.3.6, 5.4 of Edition 2015);
g) Deleted the general principles for product additional evaluation (see 4.3.1 of
Edition 2015);
h) Changed the contents of the conclusion of the adoption (see 4.8 of this Edition;
4.4 of Edition 2015);
i) Modified the contents of equivalence maintenance (see 5.9 of this Edition; 5.4 of
Edition 2015).
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority shall not be held responsible for
identifying any or all such patent rights.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee on
Disinfection Technology and Equipment of Standardization Administration of China
(SAC/TC 200).
The drafting organizations of this document. Suzhou Nojie Medical Technology Co.,
Ltd., Hangzhou Weiqiang Medical Technology Co., Ltd., Guangdong Medical Device
Quality Supervision and Inspection Institute, Xinxiang Huaxi Medical Materials Co.,
Ltd., and Terumo Medical Products (Hangzhou) Co., Ltd.
Main drafters of this document. Xu Haiying, Zhou Zhilong, Hong Zixiang, Xu Zhanli,
Cui Wenbo, Weng Hui, Liu Xuemei, Zhou Guangyu, Lin Manting.
Versions of standard substituted by this document are.
- It was first published in 2015 as YY/T 1268-2015;
- This is the first revision.
Product adoption and process equivalence for ethylene oxide
sterilization
1 Scope
This document specifies the requirements for adoption of new or changed products to
a validated sterilization process for medical devices using ethylene oxide sterilization.
It provides methods for evaluating the equivalence of sterilization processes when using
different sterilization equipment.
This document applies to medical devices sterilized with ethylene oxide using
conventional release or parametric release.
This document applies to ethylene oxide sterilization of medical devices including.
a) adding new products to a confirmed ethylene oxide sterilization process;
b) evaluating changes to confirmed products;
c) transferring a confirmed process to a different site or equipment;
d) evaluating the equivalence of sterilization processes.
2 Normative references
The following referenced documents are indispensable for the application 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.
GB 18279.1, Sterilization of health care products -- Ethylene oxide -- Part 1.
Requirements for development, validation and routine control of a sterilization
process for medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in GB 18279.1 as
well as the followings apply.
3.1 candidate equipment
New or modified equipment intended to perform an existing validated sterilization
process.
3.4 EO product family
A combination of products that are sterilized using the same process conditions and
have similar or identical validation purposes are permitted.
3.5 load configuration
The total properties of the product as it will behave during the sterilization process. This
structure includes.
3.6 packaging system
Combination of sterile barrier system and protective packaging.
3.7 process equivalence
A written evaluation that the same sterilization process can be run within specified
parameters on two or more sterilization process equipment.
3.8 product adoption
The process of introducing a candidate product into an existing, identified EO
processing category or family of ethylene oxide products.
3.9 requalification
Partial validation activities performed to confirm the continuing conformity of a
specified process.
3.10 sterilization process equipment
Including preprocessing area (if used), sterilization cabinet or sterilization cabinet,
aeration area (if used) and their respective auxiliary equipment.
4 Product adoption
4.1 General
Product adoption is generally intended to simplify the performance qualification
procedures required to introduce products into EO product family or EO processing
category. The product adoption approach described in this document includes the
establishment of EO product family and EO processing category and recommended
practices for maintaining these product families and processing categories.
4.2 Product families and processing categories
A product family is a group of products identified as having similar or identical
confirmed purposes.
4.3 Determination of adverse product effects
Before determining whether a candidate product or a candidate packaging system can
be added to a product family or processing category, it shall be determined whether the
candidate product or candidate packaging system still retains functionality and
effectiveness. The design or change control process shall provide a system for
evaluating these aspects.
4.4 Determination of impact on product design
The design of the candidate product shall be carefully reviewed for changes that create
a greater barrier to ethylene oxide gas, heat, or moisture penetration than the existing
product or process challenge device. Examples of product changes are longer lumens,
additional closures, or more bonding surfaces.
4.6 Determination of impact on sterile barrier system
The candidate product's sterile barrier system shall be examined for factors that create
barriers to the penetration of ethylene oxide, heat, or moisture. These factors could be
reduced porosity of the permeable material, reduced permeable surface area, closed
permeable surfaces, or any other feature that makes the candidate product more
challenging to sterilize than existing products or process challenge devices. In addition,
the potential impact of changes in the sterile barrier system on the product's bioburden
and ethylene oxide residuals shall be evaluated.
4.7 Determination of the impact on load configuration
The loading pattern of the candidate product shall be carefully examined for any
changes that could affect the thermodynamic response of the sterilization process.
These changes could include the addition of more layers of wrap, reconfiguration of the
tray, changes in load dimensions, changes in overall load density, or any other changes
that would make the candidate product more challenging to sterilize.
4.9 Documents
The decision on the analytical results that determine whether the candidate product can
be added to the confirmed EO product family or EO processing category shall be
documented. This document shall include at least the following.
5 Process equivalence
5.1 General
Process equivalence is a method used to demonstrate that two or more pieces of
equipment are capable of performing the same validated sterilization process. This does
not require that the equipment be identical. Even if the parameters under which the
equipment is run are statistically different, if the equipment has the ability to run the
sterilization process within the specified validated range, the process is considered
equivalent in that equipment.
5.2 Requirements for process equivalence
Process equivalence can be established regardless of whether the equipment is located
in the same location or in different locations. Before establishing a process equivalence
program, the following requirements shall be met.
5.3 Determination of process equivalence
Sterilization process equivalence between equipment is established by comparing data
obtained from running the same validated process on each equipment separately. This
comparison shall include an evaluation of the ability of the equipment to reproducibly
achieve the expected process parameters when sterilizing routine production loads.
5.4 Process analysis and evaluation
Perform data analysis related to the confirmed process for the candidate equipment and
the initial equipment. Process data shall be collected from the candidate equipment.
These data shall be compared with the parameter range of the specific sterilization
process and the data obtained during the performance qualification process of the initial
equipment.
5.5 Preprocessing or parsing area evaluation
The requirements for preprocessing or establishing process equivalence in analytical
area are the same. Usually there is no humidity requirement for the analytical area.
An evaluation shall be performed to compare the temperature and humidity profiles of
the load in each environment. At a minimum, the consistency of temperature and
humidity within the load shall be evaluated and the relationship of this consistency to
the corresponding set points and control ranges recorded for that area. If the equipment
uses different set points or has different control ranges, it may not be possible to claim
equivalence.
5.7 Microbiological evaluation
Run a partial cycle or half cycle during the microbiological evaluation to demonstrate
that the sterilization process is capable of achieving the specified minimum sterility
assurance level in all evaluated equipment.
5.8 Results evaluation
The results of the evaluation will determine whether the different equipment (sets)
operate equivalently. If the different equipment (sets) is equivalent, the tests that have
been implemented have met the requirements for performing simplified microbial
performance identification.
5.9 Equivalence maintenance
Equivalency maintenance shall include a review of changes to each piece of equipment,
manufacturing process, product loading, and sterilization process to ensure that these
changes do not affect the overall equivalence determination. This review shall be
performed prior to the change and as part of the change control process. If any process
fails the periodic equivalence review, it shall be removed from the equivalency
equipment catalog and requalified on its own.
5.10 Documents
All analytical results relevant to determining whether the candidate equipment can
claim equivalence to existing sterilization process equipment shall be documented. This
documentation shall include at least the following.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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