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YY/T 1268-2023 PDF English


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YY/T 1268-2023: PDF in English (YYT 1268-2023)

YY/T 1268-2023 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA 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 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 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. 3.11 sterilization specialist A person who has knowledge of the sterilization technology to be applied and the effects of that sterilization technology on materials and microorganisms. NOTE: This level of sterilization knowledge is acquired through both practical and theoretical means and the above-mentioned personnel do not require instruction in the basic principles of the relevant sterilization techniques involved. 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. EO product families are usually established based on similarities in product structure, material, density, packaging or difficulty of sterilization. Although product families may be used for other reasons (ethylene oxide residual, bioburden, or biocompatibility), for ethylene oxide sterilization, product families generally refer to products that are grouped together for the purpose of determining that the products have achieved the required sterility assurance level during microbiological performance qualification. When introducing a product into the EO product family, a review and analysis shall be conducted with respect to product design and function, manufacturing method, production environment or area, material composition, packaging materials, sterile barrier system and/or protective packaging structure, density, size and/or surface area, and bioburden. EO product families may consist of different combinations of similar products. For example, a product family may contain a range of catheter products that differ only in size, or may contain multiple products made from the same materials and under the same conditions. When grouping products into product families, they shall be grouped based on their suitability for the ethylene oxide sterilization process. Using a product family simplifies the validation process because all products in the family are determined to be equally or less challenging to the sterilization process than a representative product or in-house process challenge device. The family can be represented by the most difficult product to sterilize (often called the “master product”). The entire family is considered equally challenging to the sterilization process, or it can be represented by a product process challenge device. In addition to product families, processing categories may be used during process validation and routine sterilization of ethylene oxide. An EO processing category is a collection of multiple EO product families. These product families may differ in the details used to establish the product family (such as constituent materials, packaging materials, or manufacturers, etc.), but each product family in the processing category shall be qualified in the same sterilization process. For example, a group of products (such as IV set kits) may form a product family and may form an EO processing category with another category of products (such as a syringe product family). The commonality within a processing category may be an internal process challenge device that represents the microbial challenge of the products in that category. All products within the EO processing category shall present the same or less challenge to the sterilization process when compared to the most difficult to sterilize product, a representative product, or an internal process challenge device placed within the product sterile barrier system. 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. Functionality, integrity, stability, biocompatibility, and residuals shall be considered. Special consideration shall be given to the effect of the sterilization process on drugs that may be contained in the device or component. For products containing certain types of finished components (such as medicated combination packs), in addition to considering the possible effect of the sterilization process on the shelf life of the product involved, the manufacturer shall also consider regulatory requirements for the safety and effectiveness of these components. The ethylene oxide process used for product testing shall provide a representative challenge to the product and its packaging system. The difference between the challenge process and the routine process shall be documented. And product qualification shall demonstrate that these parameters are acceptable for the product. The candidate product and its packaging shall be evaluated to determine the impact on them are negligible, or that they present a less challenging condition than the currently validated product or process challenge device, then the candidate product shall be added to the EO product family or EO processing category without further study. If the answers to all questions in Annex A are “no” when used in the review process, the above decision is supported and the sterilization specialist shall list and document the reasons for the decision. If the technical review shows that the candidate product is more potentially challenging to the sterilization process than the existing confirmed product or internal process challenge device, further research is required. If it is determined that the candidate product is more challenging to the sterilization process, the product does not meet the requirements for addition to the existing EO product family or EO processing category, and performance identification shall be carried out in accordance with the requirements of GB 18279.1. The performance identification can be: a) Establish a new EO product family or EO processing category, with the selected product as a representative product; b) Establish a new in-house process challenge unit for an existing sterilization process; c) Use an existing confirmed main product to represent the candidate product; d) Establish a new sterilization process for the candidate product; e) Clarify whether the new EO product family or EO processing category contains an existing product family or product processing category. 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: a) All specifications of the candidate product, with a detailed description of the product structure and the form in which the product will be presented during the ethylene oxide sterilization process (packaging and load configuration), which shall also include or refer to the required sterility assurance level; b) Comparison of the candidate product with existing validated product. This shall clearly demonstrate that product complexity, materials, packaging and loading configurations have been evaluated. This shall also include a review of data to ensure that the candidate product functionality has not been compromised by adding it to the process; c) Evidence or evaluation of the candidate product’s bioburden and the relative resistance of the candidate product’s bioburden to in-house process challenge devices; d) Evaluation of ethylene oxide residual levels in candidate products; e) A conclusion, based on the current validation studies, that the candidate product is suitable for follow-up to the EO product family or EO processing category to achieve the specified sterility assurance level. This conclusion shall include or reference additional test results to supplement the existing validation studies, as well as further testing (e.g., residue testing, functional testing, etc.) to confirm routine release within the existing validated cycle; f) Approval by sterilization specialists within the organization and those required to implement change control. Ensure documentation is maintained and accessible. 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. The implementation of an equivalency process in multiple pieces of equipment is intended to reduce the amount of testing required for the qualification process. The sterilization process shall be validated in one of the sterilization cabinets. If the remaining pieces of equipment have completed the installation qualification and operational qualification, these pieces of equipment may only run a simplified performance qualification. Equivalency can also be used to simplify the requalification of multiple pieces of equipment. The equipment used to perform the sterilization process typically consists of a cabinet or room and ancillary control systems. The sterilization process equipment may be located in a specific facility or facilities. The equipment can be used independently to achieve the same process conditions, have the same design as other equipment, or may differ in size or ancillary equipment. Process equivalence can be established through analysis of process data in conjunction with microbiological evaluation. Process data shall demonstrate that the candidate equipment is operating within acceptable control limits (e.g., the validated process parameters are consistently achieved on the product). Data analysis shall confirm that the process is consistently operating within the specified tolerances of the validated parameters. Microbiological evaluation will demonstrate that the specified sterility assurance level is achieved. 5.2 Requirements for process equivalence calculations, normality test requirements and steps to be taken when the data does not pass the normality test. If process analysis and evaluation do not meet established acceptance criteria, process equivalence cannot be demonstrated. 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. If the performance data analysis confirms that the conditions in the load meet the parameter range (such as temperature distribution, residue level, etc.) at the end of preprocessing or aeration, the equivalence of the preprocessing or aeration process can be established. The residue level of the product shall be verified with representative products or main products in the candidate aeration room/cabinet/cavity to determine that the product release time is equivalent. 5.6 Sterilization cabinet performance evaluation An evaluation shall be performed comparing the process parameters implemented in the candidate equipment with data obtained from performance qualification or production runs of existing validated equipment. Prior to the evaluation, the key process and load parameters to be compared shall be identified for the sterilization process. These parameters will be unique to each sterilization process and shall include the following aspects. a) Loading parameters: 1) Product temperature - the temperature obtained during the entire cycle and its distribution within the load. See GB 18279.1 for the recommended number of sensors; 2) Product humidity - the humidity obtained at the end of the processing and its distribution in the load. See GB 18279.1 for the recommended number of sensors. b) Process parameters: 1) The humidity in the cabinet at a selected point in the sterilization cycle (e.g. at the end of processing or at the beginning of gas exposure). This parameter can be measured directly or can be based on the pressure rise caused by steam injection; 2) The temperature inside the cabinet at selected points in the sterilization cycle (e.g., at the end of processing or at the beginning of gas exposure); 3) The concentration of ethylene oxide in the sterilization cabinet at a selected time point during the gas dwell phase of the sterilization cycle (if measured), or the gas pressure rise or gas weight; 4) Other parameters that may be considered include: - Vacuum depth and rate at a selected time during the sterilization cycle; - Humidification time and steam injection rate; - Ethylene oxide gas injection temperature, time and gas usage (mass, concentration or pressure); - Air or nitrogen injection rate. Process data analysis is used to demonstrate that processes are equivalent or not equivalent in their ability to meet existing process parameter ranges and additional acceptance criteria. The resulting data shall be analyzed and summarized for future process equivalence determinations. 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. In addition to evaluating achievement of minimum sterility assurance levels, other factors that shall be evaluated include changes in the sterilization site or manufacturing location that affect bioburden levels of the final sterilized product. Increased distance between the manufacturing facility and the sterilization site may result in higher bioburden levels, especially for products that support microbial growth. Even for products that do not support microbial growth, differences in product manufacturing environments may result in a product with a greater or more robust bioburden than the validated product. Another issue to evaluate is the different transportation conditions for shipping products between sites, such as shipping time and seasonal effects (temperature, humidity, etc.). The evaluation of the candidate sterilization site or manufacturing site shall include an evaluation of simulated shipping or transfer of the product under specified conditions. 5.8 Results evaluation The results of the evaluation will determine whether the different equipment (sets) Annex A (informative) Guidelines for the evaluation of product adoption to EO product family or EO processing category A.1 General This guidance is not exhaustive. If the answer to any of the following questions is “yes,” further evaluation of the product performance study for the candidate product is required to determine if the candidate product is more difficult to sterilize than an existing validated product or process challenge device. A.2 Design characteristics Compared to the confirmed product, does the candidate product have: a) more restricted channels or cavities; b) fewer openings; c) more internal surfaces; d) more bonding surfaces; e) more closures. A.3 Materials and other characteristics Compared with the confirmed products, does the candidate product have: a) Changes or differences in materials or properties that may reduce penetration of heat, moisture, or sterilant; b) Materials known to adsorb higher amounts of ethylene oxide residues; c) Materials that are destroyed by ethylene oxide; d) Materials of greater biogenic origin; e) Temperature, pressure, or humidity limitations that cannot be met by existing ethylene oxide processes; f) Bioburdens that vary significantly in type, quantity, and resistance; g) Manufacturing or assembly processes that occur in uncontrolled environments; h) Less process cleaning; i) More manual handling during production. A.4 Sterile barrier systems Compared to the confirmed product: a) Does anything like the product, product packaging, or impermeable paper make the vent more obstructive? b) Is there a difference in type, number of layers, grammage, coating, or processing from the existing packaging? c) Is the type of breathable material different (e.g., permeable paper instead of nonwoven)? d) Is the porosity of the breathable material reduced (e.g., basis weight, coating, processing, or application of adhesive labels)? e) Is the surface area or base opening of the breathable material reduced? f) Does the packaging material increase the bioburden level of the product? g) Is a secondary (double layer) sterile barrier system added? h) Does the packaging design, materials, or placement of the product make the product more difficult to heat or restrict the flow of gases within the product? i) Does the sterilization process have an adverse effect on the packaging materials or closures? j) Does the arrangement of individual packages within the protective packaging make the vent more obstructive due to the impermeability of other products or the protective packaging itself? A.5 Loading characteristics Compared to the confirmed product: a) Are there any additions or changes to the outer packaging, or an increase in the number of internal interlayer packaging? b) Is additional protective packaging added? c) Are thicker or denser stretch or shrink wrap used to secure the pallet load during handling? d) Are there any changes in the composition, density or thickness of the protective Annex B (informative) Guidelines for process equivalence evaluation B.1 General When implementing process equivalence evaluation analysis, it is advisable to first ensure that the confirmed equipment and the candidate equipment use the same or similar control and monitoring systems. Use the same or similar traceable calibration methods. Through data analysis of each stage of the sterilization process, combined with the requirements of 5.7, evaluate whether the same product range can use the confirmed sterilization parameters in the candidate equipment. Use this guide in process equivalence evaluation. This guide does not cover all items. If the answer to any of the following questions is "yes", it is advisable to implement performance qualification in accordance with the requirements of GB 18279.1. B.2 Process analysis and evaluation B.2.1 Preprocessing (if any) includes the following. a) In the preprocessing stage, whether the temperature of the selected preprocessing area exceeds the temperature range of the preprocessing area used by the confirmed parameters. b) In the preprocessing stage, whether the humidity of the selected preprocessing area exceeds the humidity range of the preprocessing area used by the confirmed parameters. c) At the end of preprocessing, check whether the temperature distribution range obtained in the candidate preprocessing area exceeds the temperature distribution range obtained in the confirmed process. d) At the end of preprocessing, check whether the humidity distribution range obtained in the candidate preprocessing area exceeds the humidity distribution range obtained in the confirmed process. B.2.2 Sterilization cabinet performance includes the following. a) After loading and running the confirmed parameters in the selected sterilization cabinet: 1) Whether the temperature distribution range obtained during the entire load cycle exceeds the temperature distribution range obtained during the confirmed process; ......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.