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FDA S001 Review Questions:
富港包装测试中心 专注模拟运输验证 谢轲
15226989829
（同微信）
Sterility/Shelf Life灭菌和货架周期
1. You have provided PackageIntegrity tests and accelerated aging test report summaries. However, theinformation was unclear, and we were not able to verify that you performedSimulated Distribution testing. As noted in the 2016 FDA sterility guidance Submission and Review of Sterility InformationinPremarket Notification (510(k)) Submission forDevices Labeled as Sterile: Guidance for Industry and Foodand Drug Administration Staff, FDA recommends that packagetest methods include simulated distribution as well as simulated (and/orreal-time) aging followed each by associated packaging testing, to validatepackage integrity and shelf life claims. FDA needs this information to ensure thatyour device can withstand the rigors of shipping distribution. Please addressthe items below.
您提供了包装完整性测试和加速老化测试报告摘要。但是，这些信息并不清楚，FDA无法验证您是否执行了模拟分布测试。如2016年FDA无菌指南提交和上市前通知（510（k））无菌信息审查中所述，FDA建议包装测试方法包括模拟分布和模拟（和/或实时）老化随后进行相关包装测试，以验证包装完整性和保质期要求。FDA需要这些信息来确保你的设备能够经受住运输配送的严格考验。请答复以下提问：
a. FDA requires packagingintegrity testing to confirm the ability of the packages to maintain thesterile barrier through the rigors of shipping distribution. Please provide adescription of the method used to validate the ability of the packages towithstand the rigors of shipping distribution. You should include a descriptionof the conditions used for environmental conditioning and methods used todetermine package integrity. For packaging integrity testing, FDA recommends atleast the following tests; visual inspection, bubble leak or dye penetrationtesting, and seal (peel) strength testing.
FDA要求进行包装完整性测试，以确认包装在严格的运输配送过程中保持无菌屏障的能力。请提供用来验证包装承受运输分配的严酷性的方法描述。并包括环境条件的描述和用于确定包装完整性的方法/原理。对于包装完整性测试，FDA建议至少进行以下测试：目视检查、气泡泄漏或染料渗透测试和密封（剥离）强度测试。
b. You indicated that 12samples were tested (Test Reports SL-SBGYR-22-03 and SL-SBGYR-22-06).Please beaware that the number of samples used in package integrity testing should belarge enough to provide for statistically significant analysis with a highdegree of reliability; for example, 95% confidence at 95% reliability orgreater. Please provide scientific justification for the chosen sample size orconduct package integrity testing on a large enough sample size to provide highconfidence and reliability that the packaging will maintain the sterilebarrier.
您指出已测试了12个样品（测试报告SL-SBGYR-22-03和SL-SBGYR-22-06）(见<Package Verification Test_60ml controlring_updated>)。请注意，包装完整性测试中使用的样品数量应足够大以提供具有统计意义的分析具有高度的可靠性；例如，在95％或更高的可靠性下具有95％的置信度。请为选定的样本量提供科学依据，或对足够大的样本量进行包装完整性测试，以提供使包装保持无菌屏障的高置信度和可靠性。
c. If you have not conductedsimulated shipping distribution testing followed by appropriate packagingintegrity testing, we have the following general recommendations.
如果您还没有进行模拟运输测试，然后再进行适当的包装完整性测试，则我们有以下一般建议。
i. Please be aware that thetesting should be conducted on final, finished devices.
测试样品为最终灭菌后的样品
ii. For environmental conditioningprior to simulated shipping distribution, test samples should be exposed todifferent anticipated environmental conditions of cold, hot, and humidity thatyour device might be exposed to.
为了在模拟运输试验前设置环境条件，应将测试样品暴露于该产品可能暴露的不同预期冷，热和潮湿环境条件下。
iii. Please be aware that thenumber of samples used in package integrity testing should be large enough toprovide for statistically significant analysis with a high degree ofreliability; for example, 95% confidence at 95% reliability or greater.
请注意，包装完整性测试中使用的样品数量应足够大，以提供具有高度可靠性的统计显着性分析；例如，在95％或更高的可靠性下具有95％的置信度。
iv. In addition, devicespecific performance testing as appropriate should be conducted to determinewhether the rigors of shipping and distribution may affect the performance ofyour device.
此外，应进行特定的性能测试，以确定严酷的运输和发运方式是否会影响产品性能。
1. ISO 11607-1:2006/(R)2010,Packaging for terminally sterilized medical devices – Part 1: Requirements formaterials, sterile barrier systems, and packaging systems.
2. ISO 11607-2:2006/(R)2010,Packaging for terminally sterilized medical device – Part 2: Validationrequirements for forming, sealing, and assembly processes.
3. ASTM D4332-14, StandardPractice for Conditioning Containers, Packages, or Packaging Components forTesting
4. ASTM D4169-14, StandardPractice for Performance Testing of Shipping Containers and Systems
富港包装测试中心 专注模拟运输验证 谢轲
15226989829
（同微信）
2020年06月30日 11点06分
1
富港包装测试中心 专注模拟运输验证 谢轲
15226989829
（同微信）
Sterility/Shelf Life灭菌和货架周期
1. You have provided PackageIntegrity tests and accelerated aging test report summaries. However, theinformation was unclear, and we were not able to verify that you performedSimulated Distribution testing. As noted in the 2016 FDA sterility guidance Submission and Review of Sterility InformationinPremarket Notification (510(k)) Submission forDevices Labeled as Sterile: Guidance for Industry and Foodand Drug Administration Staff, FDA recommends that packagetest methods include simulated distribution as well as simulated (and/orreal-time) aging followed each by associated packaging testing, to validatepackage integrity and shelf life claims. FDA needs this information to ensure thatyour device can withstand the rigors of shipping distribution. Please addressthe items below.
您提供了包装完整性测试和加速老化测试报告摘要。但是，这些信息并不清楚，FDA无法验证您是否执行了模拟分布测试。如2016年FDA无菌指南提交和上市前通知（510（k））无菌信息审查中所述，FDA建议包装测试方法包括模拟分布和模拟（和/或实时）老化随后进行相关包装测试，以验证包装完整性和保质期要求。FDA需要这些信息来确保你的设备能够经受住运输配送的严格考验。请答复以下提问：
a. FDA requires packagingintegrity testing to confirm the ability of the packages to maintain thesterile barrier through the rigors of shipping distribution. Please provide adescription of the method used to validate the ability of the packages towithstand the rigors of shipping distribution. You should include a descriptionof the conditions used for environmental conditioning and methods used todetermine package integrity. For packaging integrity testing, FDA recommends atleast the following tests; visual inspection, bubble leak or dye penetrationtesting, and seal (peel) strength testing.
FDA要求进行包装完整性测试，以确认包装在严格的运输配送过程中保持无菌屏障的能力。请提供用来验证包装承受运输分配的严酷性的方法描述。并包括环境条件的描述和用于确定包装完整性的方法/原理。对于包装完整性测试，FDA建议至少进行以下测试：目视检查、气泡泄漏或染料渗透测试和密封（剥离）强度测试。
b. You indicated that 12samples were tested (Test Reports SL-SBGYR-22-03 and SL-SBGYR-22-06).Please beaware that the number of samples used in package integrity testing should belarge enough to provide for statistically significant analysis with a highdegree of reliability; for example, 95% confidence at 95% reliability orgreater. Please provide scientific justification for the chosen sample size orconduct package integrity testing on a large enough sample size to provide highconfidence and reliability that the packaging will maintain the sterilebarrier.
您指出已测试了12个样品（测试报告SL-SBGYR-22-03和SL-SBGYR-22-06）(见<Package Verification Test_60ml controlring_updated>)。请注意，包装完整性测试中使用的样品数量应足够大以提供具有统计意义的分析具有高度的可靠性；例如，在95％或更高的可靠性下具有95％的置信度。请为选定的样本量提供科学依据，或对足够大的样本量进行包装完整性测试，以提供使包装保持无菌屏障的高置信度和可靠性。
c. If you have not conductedsimulated shipping distribution testing followed by appropriate packagingintegrity testing, we have the following general recommendations.
如果您还没有进行模拟运输测试，然后再进行适当的包装完整性测试，则我们有以下一般建议。
i. Please be aware that thetesting should be conducted on final, finished devices.
测试样品为最终灭菌后的样品
ii. For environmental conditioningprior to simulated shipping distribution, test samples should be exposed todifferent anticipated environmental conditions of cold, hot, and humidity thatyour device might be exposed to.
为了在模拟运输试验前设置环境条件，应将测试样品暴露于该产品可能暴露的不同预期冷，热和潮湿环境条件下。
iii. Please be aware that thenumber of samples used in package integrity testing should be large enough toprovide for statistically significant analysis with a high degree ofreliability; for example, 95% confidence at 95% reliability or greater.
请注意，包装完整性测试中使用的样品数量应足够大，以提供具有高度可靠性的统计显着性分析；例如，在95％或更高的可靠性下具有95％的置信度。
iv. In addition, devicespecific performance testing as appropriate should be conducted to determinewhether the rigors of shipping and distribution may affect the performance ofyour device.
此外，应进行特定的性能测试，以确定严酷的运输和发运方式是否会影响产品性能。
1. ISO 11607-1:2006/(R)2010,Packaging for terminally sterilized medical devices – Part 1: Requirements formaterials, sterile barrier systems, and packaging systems.
2. ISO 11607-2:2006/(R)2010,Packaging for terminally sterilized medical device – Part 2: Validationrequirements for forming, sealing, and assembly processes.
3. ASTM D4332-14, StandardPractice for Conditioning Containers, Packages, or Packaging Components forTesting
4. ASTM D4169-14, StandardPractice for Performance Testing of Shipping Containers and Systems
富港包装测试中心 专注模拟运输验证 谢轲
15226989829
（同微信）