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YY/T 0681.1-2018: Test methods for sterile medical device package - Part 1: Test guide for accelerated aging
YY/T 0681.1-2018
Test methods for sterile medical device package--Part 1.Test guide for accelerated aging
ICS 11.080.040
C31
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 0681.1-2009
Sterile medical device packaging test methods
Part 1.Guide to accelerated aging test
2018-12-20 released
2020-01-01 Implementation
Issued by the State Drug Administration
Preface
YY/T 0681 "Test Method for Sterile Medical Device Packaging" is divided into 16 parts.
---Part 1.Guide to accelerated aging test;
---Part 2.Sealing strength of soft barrier materials;
---Part 3.Unconstrained packaging resists internal pressure damage;
---Part 4.Dyeing liquid penetration method to determine the seal leakage of breathable packaging;
---Part 5.Internal pressure method to detect gross leaks (bubble method);
---Part 6.Evaluation of chemical resistance of printing ink and coating on flexible packaging materials;
---Part 7.Use tape to evaluate the adhesion of ink or coating on flexible packaging materials;
---Part 8.Determination of the weight of the adhesive layer;
---Part 9.Seal burst test of flexible packaging by air pressure inside restraint plate;
---Part 10.Microbial barrier grading test for breathable packaging materials.
---Part 11.Visual inspection of medical packaging seal integrity;
---Part 12.Anti-rubbing of soft barrier film;
---Part 13.Soft barrier film and composite film resistance to slow puncture;
---Part 14.Test of moisture and dry microbial barrier of breathable packaging materials;
---Part 15.Performance test of transport containers and systems;
---Part 16.Test of Climate Response Capability of Packaging System.
This part is Part 1 of YY/T 0681.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY/T 0681.1-2009 "Test Methods for Packaging of Sterile Medical Devices Part 1.Guidelines for Accelerated Aging Tests",
Compared with YY/T 0681.1-2009, the main technical changes except for editorial changes are as follows.
--- For aseptic packaging, use the term "sterile barrier system" instead of the term "package";
--- "Actual time aging" is uniformly revised to "Real-time aging";
--- Clause 4.2 in "Meaning and Application" is amended to "Packaging System Should";
---Add clause 4.5 in "meaning and application";
---The thermometer is required to be "recordable" in "Instrument" 5.4;
---Add clause 6.5 in "Accelerated Aging Theory";
--- Delete "For example, the selected temperature should be at least 10℃ lower than the Tg of the material" in clause 7.2.3 of the "Accelerated Aging Plan";
--- Added Note 3 and Note 4 under clause 7.2.3 of "Accelerated Aging Plan";
---Add clause 7.4.5 to the "Accelerated Aging Plan";
---Deleted clause 7.5 in the "accelerated aging plan";
--- The "8 Aging Test Guide" has been revised as a whole;
---Appendix B deleted Figure B.1;
--- Appendix B.5 deletes "If appropriate, it may be carried out in accordance with ASTMD4169 specifications";
--- The note in Appendix B.6 is amended as "The influence of humidity can be used as a packaging system design";
---Add Appendix C (informative appendix) "Relative Humidity Used in the Aging Plan".
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
Drafting organizations of this section. Shandong Medical Device Product Quality Inspection Center, DuPont (China) R and D Management Co., Ltd., Shandong Weigao Set
Tuan Medical Polymer Products Co., Ltd., Medico (Shanghai) Packaging Materials Co., Ltd.
The main drafters of this section. Zhang Jing, Qian Jun, Yu Haichao, Gong Yaoren.
This part replaces YY/T 0681.1-2009.
Sterile medical device packaging test methods
Part 1.Guide to accelerated aging test
1 Scope
This part of YY/T 0681 specifies guidelines for designing accelerated aging schemes.
This section is suitable for quickly determining the aseptic integrity of the sterile barrier system and its packaging materials specified in GB/T 19633.1-2015
The physical properties of the components are affected by the elapsed time.
Note 1.Use the information obtained in this part of YY/T 0681 to support the validity period (ie shelf life) of the sterile barrier system of medical devices.
This section does not apply to real-time aging schemes.
Note 2.The accelerated aging test involves the entire sterile barrier system with or without devices. This section does not involve the sterility required in the development or evaluation of new products.
Compatibility of barrier system material and device interaction.
Note 3.The real-time aging test is a basic aging study used to determine the results of the accelerated aging test.
Note 4.This section does not involve the method of confirmation of the sterile barrier system, including the impact of mechanical processing, sterilization process, circulation, handling and transportation events. no
See YY/T 0681.15 for the ability of the bacterial barrier system to resist transportation challenges.
Note 5.This section does not involve the influence of extreme climatic conditions that may be experienced in the simulated transportation environment. Climate response capability test of sterile barrier system
See YY/T 0681.16.
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 article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 4857.2 Basic test of packaging and transportation packages Part 2.Temperature and humidity adjustment treatment
GB/T 19633.1-2015 Terminally sterilized medical device packaging Part 1.Material, sterile barrier system and packaging system
Claim
3 Terms and definitions
The following terms and definitions defined in GB/T 19633.1-2015 apply to this document.
3.1
Acceleratedaging
Store the sample at a higher temperature to shorten the time to simulate real-time aging.
3.2
Acceleratedagingfactor
An estimated or calculated ratio of time to the same level of change in physical properties of a package stored in real-time conditions.
Note. The aging factor (Q10) when the temperature increases or decreases by 10°C is a conservatively estimated accelerated aging factor.
3.3
Accelerated aging temperature
A certain higher temperature that enters the aging study is calculated based on the estimated storage temperature, estimated use temperature, or both.
3.4
Accelerated aging time
The duration of the accelerated aging test.
3.5
Ambient temperature
The storage temperature of the sample representing the actual aging time of the storage condition.
3.6
Sterile barrier system shelf life sterile barrier system shelf life
The expected storage time for the sterile barrier system to maintain its key performance parameters under environmental conditions or prescribed storage conditions.
Note. "Shelf life" is a term often used in my country's regulatory documents, and is called "validity period" in GB/T 19633.1-2015.
3.7
Real-timeaging
The aging process of storing samples under ambient conditions.
Note. The term "real-time aging" is also called "real time aging" in GB/T 19633.1-2015.
3.8
Real-time equivalent
Estimated duration equivalent to real-time aging for a given accelerated aging condition.
3.9
Zero time
The start time of the aging study.
4 Significance and application
4.1 The decrease in physical properties of materials over time and the degradation of materials at the bonding or heat-sealing points over time and the subsequent transportation and handling
Dynamic events may lead to the loss of the integrity of the sterile barrier system.
4.2 The packaging system should provide physical protection and maintain the integrity of the sterile barrier system. The sterile barrier system should be before use or expiration date
Keep its sterile condition inside. The stability test should confirm that the sterile barrier system always maintains its integrity. Stability with accelerated aging scheme
The test should be considered as sufficient evidence of the nominal validity period before the actual aging study data is issued.
4.3 The real-time aging program provides the best data to ensure that the sterile barrier system materials and the integrity of the sterile barrier system do not degrade over time.
However, under the market conditions where products are updated rapidly, new products need to be put on the market in the shortest possible time, and real-time aging research cannot satisfy
For this purpose. Accelerated aging research provides another alternative method. To ensure that accelerated aging research truly represents real-time aging
Effect, real-time aging research should be carried out simultaneously with accelerated aging research. The real-time aging study should be carried out to the nominal shelf life of the product and to
carry out.
4.4 If there is a lack of understanding of the sterile barrier system materials being evaluated, conservative accelerated aging factors should be used. Can be used more realistically
Accelerated aging factor, but documented evidence should be used to show the relationship between real-time aging and accelerated aging.
4.5 When performing accelerated aging procedures to establish a nominal shelf life, it should be recognized that the data obtained in the study is based on the
Simulation of the effect. The established expiration date or shelf life is based on conservatively estimated aging factors (such as Q10).
The real-time aging study of the barrier system is only temporary until completion.
Note. The determination of accelerated aging factors is outside the scope of this guide.
5 Instruments
5.1 Room (or box), the size of which allows the sample to be independently exposed to circulating air at a selected temperature and relative humidity.
5.2 The control instrument can make the room (box) maintain the required atmospheric conditions within the limit deviation.
5.3 Hygrometer, a device used to indicate relative humidity, and its relative humidity accuracy should be ±2%.
Note. The wet and dry bulb thermometer can directly measure the relative humidity, and it can also be used to check the hygrometer.
5.4 Thermometer, any measuring device capable of recording and displaying temperature with an accuracy of 0.1℃ can be used.
Note. The dry-bulb thermometer of the wet-dry bulb thermometer can directly measure the temperature, and it can also be used to check the temperature display device.
6 accelerated aging theory
6.1 Accelerated aging of materials refers to the accelerated changes of material properties related to the safety and functionality of materials or sterile barrier systems over time.
6.2 In an aging study, subject the material or sterile barrier system to more severe or frequent conditions than the usual environment in a relatively short period of time.
External strain.
6.3 The accelerated aging technology is based on the assumption that the chemical reaction in material degradation follows the Arrhenius reaction rate function. This letter
The number indicates that every 10℃ increase or decrease in the temperature of the homogeneous process will approximately double or halve the rate of the chemical reaction.
6.4 The method for determining Q10 is to test each material at various temperatures and define the reaction rate between each material for every 10°C change in temperature
The difference. It is very complicated and difficult to establish a dynamic model of material degradation, which is beyond the scope of this section.
6.5 The accelerated aging time calculation in the accelerated aging scheme does not use the humidity factor, but the extreme temperature and humidity that do not match the actual conditions
Conditions may affect the performance of the entire sterile barrier system. This should be studied separately and has nothing to do with the aging of the material.
7 Accelerated aging plan
7.1 Material characterization
The accelerated aging theory and its application are directly related to the composition of packaging materials. Material properties that may affect the results of accelerated aging studies
include.
a) composition;
b) Morphology (glassy, amorphous, semi-crystalline, highly crystalline, percent crystallinity, etc.);
c) Thermal conversion temperature (Tm, Tg, Tα);
Note. Tm. melting temperature of the material; Tg. glass transition temperature; Tα. Alpha temperature, heat distortion temperature.
d) Additives, process aids, catalysts, lubricants, residual solvents, corrosive gases and fillers.
7.2 Design Guidelines for Accelerated Aging Program
7.2.1 Temperature limits should be considered based on the characterization of medical devices and sterile barrier system materials to ensure that the initial conservative aging factors are appropriate.
should. The temperature used in the test should be determined according to the characteristics of the packaging material and the expected storage conditions. Material characterization and composition are established to accelerate aging
The temperature limit is a factor, the temperature selection should avoid any physical transformation of the material.
7.2.2 Choose room temperature or ambient temperature that can represent the actual product storage and use conditions.
Note. The temperature is usually between 20°C and 25°C, and a temperature of 25°C is considered a conservative value.
7.2.3 Select the accelerated aging temperature on the basis of material characterization. The higher the accelerated aging temperature, the greater the accelerated aging factor, thus accelerating aging
The shorter the transformation time. It should be noted that the accelerated aging temperature cannot be increased uncontrollably to shorten the accelerated aging time. Excessive temperature can
It can have an impact on the material that is impossible at real-time temperature or room temperature (see Appendix A). Select the aging temperature according to t...