DDL在加利福尼亚州的Fountain Valley和明尼苏达州的Eden Prairie的实验室中扩大了医疗设备包装测试的能力。
该扩展包括在其最近在Fountain Valley Laboratory开设的设施中添加更多的室，以增加环境条件的能力，real time aging和加速老化试验。伊甸草原设施也增加了额外的房间容量。
DDL总经理Corey Hensel说：“这种扩展使我们有更多的能力按照ISO 11607的要求进行包装验证预处理。”“这种额外的容量还使我们可以为我们的医疗设备客户提供更快的周转速度，尤其是具有大量包装验证的量。立即将验证样本放置在其条件和衰老环境中的能力有助于减少开发时间，并缩短所有客户的产品时间。”
许多医疗设备制造商（MDMS）与制定包装系统设计资格测试计划的制定合规性ISO 11607。ISO 11607requires that sterile medical device package systems be capable of withstanding the transportation and distribution environment. This is typically accomplished by performing a package performance test protocol consisting of a series of laboratory tests that simulate the dynamic and environmental hazards associated with the distribution of products to their end use.
分配模拟测试是一种通过利用实验室设备使包装系统遇到可能发生在预期的分销环境中的特定危害的统一且可重复的方法。主要目标是具有有效的运输配置，可保护产品和包装完整性在运输过程中，并最终符合ISO 11607。
许多MDMS面临的一个挑战是确定要指定性能测试的程序。有几种分发模拟测试方法可用于软件包性能测试。
ISO 11607标准建议使用ASTM和ISTA标准来模拟实验室中的这些危害。这ASTM D4169Standard已在医疗设备行业中广泛用于FDA合规性，并具有将高性能包装设计用于商业的稳定历史，并确定了潜在的故障和危害。ISTA测试方法也是许多MDMS用于遵守ISO 11607的ASTM方法的可接受替代方法。
这re are a couple of issues to consider when determining which standard to use for compliance purposes. The first is whether the test method is recognized as a consensus standard by FDA. The second is whether the test intensity of the procedures simulating the environment in which the packages will be transported is realistic.
Below are a few tips to consider before making any decisions on your distribution simulation testing.
When labeling a product, ensuring that you are using the best combination of materials to present the product as intended to the end user and while reducinge costs as much as possible are major considerations. There are a seemingly unlimited number of different types of label materials and inks both with different properties. When it comes to quickly and easily testing the durability of inks and substrates of prospective materials, there’s no better test thanASTM D5264; Standard Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester.
DDL最近添加了执行的功能Sutherland rub test显然，人们对Sutherland Rub测试及其提供的信息存在一些误解。本文将有助于解释测试的基本目的以及人们期望从设计完好的测试程序中获得的信息类型。
这Sutherland rub test is designed to provide qualitative, comparative data for the abrasion durability of multiple label constructions. The ASTM standard does not provide any pass/fail criteria for the testing as the test is only for comparing relative performance and not designed to set a particular standard. The test is not designed to replace any other tests (transportation simulation testing, for instance) which may, directly or indirectly, give information about the suitability of a label construction.
为了有效测试多个标签构造，必须调整三个测试变量才能优化测试。这些变量是：
目的是选择测试变量，以便在测试完成后，每种标签类型的降解程度都有明显的差异。例如，如果测试设置过于严格，则所有标签都将被降低到无法确定哪个执行最佳状态的地步。在另一侧，如果测试不够严格，即使最弱的结构也可能不会显示出任何降解。通常，需要为每个不同的标签构造进行探索性测试，以最好地确定用于测试所有标签构造的最佳测试变量设置。
当符合几个可能的标签构造资格时，重要的是要了解Sutherland Rub测试的目标及其可以提供的信息。精心设计的实验可以帮助您确定墨水和底物组合，从而为您提供最耐用，最具成本效益的解决方案。
随着“及时”心态在医疗设备行业中变得越来越普遍，这也导致了更多的包装验证测试项目被赶到并留在最后一刻。
While the “Just-in-Time” mentality is here to stay, it is also important to realize that this “Just-in-Time” mentality can pose a significant risk of compromising the overall validation of your package testing. In some instances, for example, we are seeing MDMs with test projects that just can’t be done in the timeline being requested. Or the quantities of samples they produce are not adequate to meet any type of statistical significance.
话虽如此，包装工程师可以做一些事情来帮助改善测试过程。
MDM和测试实验室的最终目标应该相同：验证包装和/或产品以将安全有效的产品推向市场。
Please don’t hesitate to联系我们如果您对即将进行的测试有疑问，或者需要对项目的报价。
＃5 -Empower Employees to Drive Sustainability
Employees are a powerful asset in the effort to improve sustainable practices. They are the people who see firsthand the daily practices in the lab space. Training them to think in a sustainability context will bring forth many unforeseen opportunities for improvement that otherwise may have gone unnoticed. Providing a venue for active dialog between management and staff enables continual improvement of processes and bestows added value unto the workforce.
定期提供培训（半年度）将使员工思考可持续性，并鼓励对上述实践的持续实施。有效地看到这些措施的最佳方法是在工作场所建立可持续性文化。
#4 –定期评估当前实践
必须收集和分析信息，以了解可持续性的当前绩效。如果公司遵守ISO 14001等标准或拥有环境管理系统，则该实践将已经发生。但是，如果没有，则有几种基准性能的方法。
随着实施减少废物的努力，每天跟踪产生的废物量。在添加热屏障，绝缘等之前和之后，实验室空间中的地图温度和湿度数据提供了改进的具体证据。随着更改的实施，跟踪能源消耗以证明这些程序的成本节省功能。
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