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HealthPack 2018回顾

作者：DDL销售支持专家Alison Payton

DDLonce again was a sponsor and attendee of the annualHealthPack会议。This year’s conference was held in Kansas City, MO. In addition to enjoying all the great BBQ, we heard from several leaders in the industry regarding Smart Packaging & Industry 4.0, upcoming changes toISO 11607, insights from the FDA, and of course, the ever popular Nurses Panel.

Following is a recap of the highlights, industry changes and topics discussed at HealthPack 2018:

  • 埃德·邓恩（Ed Dunn），Johnson＆Johnson卓越包装中心全球供应链负责人, opened up the conference with a Keynote discussion on “Industry 4.0” and what this means for Packaging and Healthcare. Dan Burgess,Principal Packaging Engineer & Manager at Boston Scientific, enlightened us about Smart Packaging and how these various new technologies, such as RFID technology, add value to our operations and provide more data about the transit and storage environments through tracking and remote sensing.
  • 斯科特·利维（Scott Levy），Packaging Engineer at DDL, participated in HealthPack’s Preconference Roundtable regarding the new clause in upcoming revisions toISO 11607-1。迈克尔·斯科拉（Michael Scholla），杜邦的监管标准全球总监和Thierry Wagner,Regulatory Affairs Director EMEA at DuPont Medical and Pharmaceutical Protection，在主会议上的演讲中详细讨论了这些重要的修订。这是他们演示的要点：
    • New language will be added that encompasses the concepts of sterile package ‘maintaining sterility up to the point of use’, design allows for ‘easy and safe handling’ and the package ‘integrity bring evident’ to the final user.
    • In addition, the revisions include requirements on demonstrating the usability and aseptic presentation of the sterile package.
    • 需要在指示无菌障碍系统的包装上提供新的要求，以及制造的月份和年份以及有关使用在使用前损坏或无意间打开的指令。无菌障碍协会正在研究提出的符号，以满足这一要求。
    • Lastly, a new section with requirements for validation and changes will be added that describes that packaging systems that meet the requirements of design, usability, performance testing and stability testing shall be considered validation and revalidation will occur if there are changes to the design, contents, materials or shipping configurations.
  • Scott also participated in the “Systemic Approach to Seal Strength” Panel Discussion alongside Rod Patch,Johnson＆Johnson的医疗设备卓越包装中心主任, Goeff Pavey,Technology Manager at Oliver Healthcare Packaging，托马斯·麦克纳布（Thomas McNabb），Principal Project Engineer at Medtronic Neurovascular, and Nick Layman,Ethicon的员工特许包装开发工程师。小组讨论通过解决有关最低密封强度的几个行业担忧来吸引观众（注意：最低密封强度的行业标准！），并根据设备的特征和运输配置来定义密封强度值。Ethicon的Nick Layman指出：“密封强度是特定于产品的！它必须与您的产品及其重量有关。考虑您的客户将如何交付它。”斯科特（Scott）讨论了密封强度价值的高分和低点需要科学地证明和合理化为什么选择它们，这最终将取决于您的设备和包装设计

HealthPack的其他会议包括：

  • FDA的观点：帕特里克·韦克塞尔（Patrick Weixel）提出的包装过程的自愿召回和缺陷，FDA的代理副办公室副总监
  • 大卫·达瓦卡罗（David Divaccaro）提出的成功补救的六个步骤，Divaccaro咨询小组的校长
  • Live Audience Interactive Polling Session
  • 詹妮弗·范·穆尔科姆（Jennifer van Mullekom）提出的样本量策略规划和优化，弗吉尼亚理工学院统计实践副教授兼跨学科统计分析实验室主任
  • Material Selection in Flexible Packaging, presented by Dhuanne Dodrill,Rollprint包装产品的总裁
  • Let’s Make SBS Seal Strength Testing Really Easy! presented by Sameer Upadhyaya,Genentech技术主管

总而言之，HealthPack 2018引人入胜和启发性，也是与医疗保健包装行业许多人建立联系的好方法。

HealthPack 2019将在俄勒冈州波特兰市波特兰市区举行。2019年3月5日至7日。有关HealthPack的更多信息，请访问https://www.healthpack.net。

第二部分：ASTM F1980加速衰老的概述

在此版本的DDL的Packreview系列中，DDL包装工程师Scott Levy和Peter Johnson解决了他们收到的一些常见问题ASTM- F1980加速衰老测试。这是系列的第二部分。请点击这里to view part one.

相对湿度在加速衰老中起什么作用？

加速老化是基于时间和温度。Humidity doesn’t play a role in the Q10 factor used to determine the amount of time required. A package should be aged at low relative humidity because as the temperature is elevated you must also mimic that same about of moisture content. For example, if you are using a test temperature of 55° with a 60% relative humidity and look at the moisture content, you will be over 100% moisture rate. In the real world you are not aging your samples at 55 to 60°C. Thus, you do not want to cause a failure you are not going to see in real time aging.

加速衰老之后会发生什么？

加速衰老是一个条件步骤。它不会告诉您是否通过或失败，这是加速衰老后出现的表明通行证或失败的原因。加速衰老后包装强度测试和integrity testingto make sure there isn’t a sterility breach in the package. If it is product testing, you want to go through all of the tests that you would have done at time-zero or your baseline to ensure aging hasn’t caused adverse effects and compare those results back up.

Why is Real Time Aging important?

实时老化很关键。如果您有一个设备，并且该设备在三年的到期日期坐在架子上，到三年过去了，产品可能已经过时了。因此，加速衰老使客户能够更快地将产品推向市场。实时老化是确定的数据，将样品存储在架子上，以在相同的特定到期日期中存储在架子上。

Issues seen with Accelerated Aging

计划是加速衰老的第一问题。当客户说“我需要在下个月之前运行五年到期日期”时，没有物理方法可以做到这一点。即使将温度移至100°C。有些人可能会继续提高温度，以满足发布日期的特定需求。将样品超过60°C是一个危险信号，将在监管审查中出现。您很可能会通过选择不会现实地模仿现实世界的测试温度来遇到产品性能和包装系统故障的问题。

Thank you for watching Part two of DDL’s PackReview series on ASTM-F1980 Accelerated Aging. If you have any questions, or would like a quote, pleasecontact usto speak with one of our packaging engineers.

DDLRelocates its California Laboratory

DDL宣布已将其加利福尼亚实验室从喷泉谷搬到位于尔湾的设施。新设施使实验室空间增加了一倍，这将增加DDL的包装测试能力和增长能力，以更好地满足客户的测试需求。

“Our new California facility in Irvine reflects both our continued business growth and our commitment to offering our customers the best packaging and distribution testing experience possible,” said Corey Hensel, General Manager, DDL. “This additional capacity also allows us to provide faster turnaround for our medical device and pharmaceutical customers, which helps reduce development lead time and shorten product time-to-market for all of our customers.”

新的DDL实验室位于9400 Toledo Way，Irvine，CA 92618。

Watch a video tour of the new DDL West laboratory.

Pleasecontact us有关我们新加州测试地点的更多信息，或收到报价。

DDLAdds Photostability Testing to its Portfolio

DDL现在提供光稳定性测试at its Eden Prairie, MN lab facility to assess the response to light exposure of pharmaceutical and combination products, cosmetics and other products.

Photostability testing simulates lighting that may be encountered during the product lifecycle, such as sunlight or fluorescent lights. After exposure, the samples are compared with a control sample to determine if significant changes occurred.

“Photostability testing is an important component of many testing regimens to ensure products and packages will not be adversely impacted by various lighting conditions,” said Corey Hensel, General Manager, DDL, Inc. “DDL is an experienced testing laboratory that offers efficient study management and fast turn-around to satisfy our customer’s photostability testing needs.

Pleasecontact us有关光稳定性测试或接收报价的更多信息。

ASTM F1980加速衰老的概述 - 第1部分

In this edition of DDL’s PackReview series, DDL Packaging Engineers Scott Levy and Peter Johnson discuss some of the common questions they receive onASTM F1980加速衰老Testing:

什么是加速衰老？
我加速老化s a process of putting packaged products into a chamber, elevating the test temperature to claim a specific expiration date for a medical device product or package. ASTM-F1980 is meant for sterile medical packaging but many companies and or organizations have been using it to claim specific expiration dates for their products.

When to use it?
Primarily medical device manufacturers will use accelerated aging in their package validation to be in compliance withISO 11607。

How does AA work?
ASTM-F1980 is the document; the theory itself is the Q10 theory. For every 10 degree increase it doubles the reaction rate of the materials. This Q10 factor came from the food industry. This is not an exact science but the FDA allows you to use this theory to get your products to market faster. But you will need to follow it up with real time aging. In doing so, you want to have conclusive evidence that you are not going to have issues with your package or product for that specific shelf life.

Can you use any temperature for AA?
您需要了解在选择要正常工作的测试温度之前的软化或熔点。加速老化是用于均质材料的，而大多数医疗设备由多种材料组成可能会导致麻烦。DDL软件包工程师Scott Levy讲述了一个故事，他在DDL的职业生涯早期与一位想要使用70°C的客户合作，以​​加速使用PETG托盘的产品。斯科特（Scott）在星期五将托盘放入会议厅，并在下一个星期一被污泥，并在会议厅的底部变形。这是一个很棒的教训，从那时起，斯科特（Scott）确保与客户合作，以​​确保他们为加速衰老的需求选择适当的温度。

有关信息的更多详细信息，请观看我们有关加速老化第1部分的介绍视频。

如果您有任何疑问，或者需要有关加速衰老或其他测试服务的更多信息，请联系us to speak with one of our packaging engineers.

DDL和Gateway分析宣布联合协议

DDL和网关分析announced the two companies have entered into a joint agreement to offer complementary testing services to the pharmaceutical, biotech and medical device industries.

DDL将提供设备，ASTM测试方法服务以及稳定性采样和存储的机械测试，作为协议的一部分。Gateway Analytical是一项合同分析实验室，为药品，材料科学和取证行业提供标准和新颖的分析测试技术，将提供外国颗粒表征，材料表征和可提取的浸润研究。

“DDL is excited to be working with Gateway, an established expert in the field of particulate analysis and identification,” said Corey Hensel, General Manager with DDL. “This agreement allows our mutual customers to better leverage the expertise both companies offer to help life science companies bring their products to market.”

“Gateway Analytical is pleased to be in collaboration with DDL,” says David Exline, President at Gateway Analytical. “This agreement allows us to offer our clients a more comprehensive range of solutions and expertise in both common and specialized areas. We see excellent benefits in achieving mutual business objectives by working with DDL.”

DDL和Gateway will be jointly attending the7thEdition PFS & Injectables Summitbeing held September 26-28 in San Diego, CA.

Pleasecontact usfor more information on DDL’s and Gateway Analytical’s services.

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