以下是与之讨论DDL Packaging Engineer, Scott Levyon current trends in package testing and the impact COVID has had on package testing projects.
What is new these days when it comes to package validation testing?
Despite the recent revision toISO 11607,实际的包验证测试本身并没有从过去变化过多。更新的ISO 11607标准的大部分是谈论最终用户的更多澄清。许多客户忽略的一个区域是如何将标签检查作为包验证的一部分执行。FDA最近一直在询问来自标签的粘附,易读性等的一些问题。
Covid如何影响包裹测试项目?
Tremendously. The first aspect is with customers being able to get specific materials from suppliers for projects such as pouches, trays, lids etc. We have been hearing from many clients that many material vendors are four to six weeks out with various supplies.
我们看到的另一个方面已经延迟了package validation testing相当有点是灭菌备份。仅凭医疗设备制造商可以将产品带来市场的速度迅速,这一部分巨大影响,以及延迟整体时间表。
这些类型的延迟大大影响了整体验证。因此,项目正在进行更多时间才能执行。在过去,当大多数客户联系我们来做包验证时,他们就准备好了立即开始。现在客户正在推出四五个月的东西,整体周期更长。
In working with clients last year during the height of the pandemic, many clients decided they were going to hold tight on their projects and watch their spending. Moving forward into 2021, we are starting to see clients come back because they understand that even though we are still dealing with the pandemic, they need to forge forward with projects.
What are some tips that you have for customers doing package testing during COVID?
The biggest tip is when you are working with your supplier is identifying and have all of the information upfront.
有了这么多人在这些日子里从家里(包括我们的许多人)工作,对能够连续所有鸭子的吞吐量产生了巨大影响,以便能够具体地与您的供应商与您的供应商交谈您需要以及您需要的数量。我们理解从家中工作的工程师,他们没有易于使用的所有这些信息。但是,他们需要很快成本核算,以便他们可以回到项目团队并提供预计的预算。虽然ISO 17025实验室,但是,由于我们希望拥有每一个特质,因此可以在没有任何问题的情况下妥善处理,并且在没有任何问题的情况下,验证的所有权都可以妥善处理项目,并且一切都以满足和执行验证,所有的项目都是100%的。如果成本最终是与项目向前迈进的主要原因,致力于假设,这不是制定首先选择哪些供应商的决定的好方法。
We are also noticing many clients and potential clients who are working from home are often not including a telephone number where they can be reached, so almost all correspondence is happening via teams, zoom or email. Once an inquiry does come through with many questions, many people like to continue communicating via email rather than jumping on the phone. As a result, it can sometimes take up to five or seven email exchanges before the true needs of the customers is fully identified, whereas things could progress much faster with one phone call. For as great as technology is these days, sometimes a simple phone conversation outweighs dozens of back and forth emails to get to the root of the issue.
Do you see any changes coming about with package testing due to COVID?
As was discussed earlier, many companies are moving forward again with projects, as they understand they have to move forward. If the material suppliers and sterilizations start to get back on top of things with better turnaround, package testing will continue to move fast and swift because there’s a lot of projects that did not happen last year that were probably slated to happen. As a result, we are likely going to see an uptick. Thus, why having all the information up front to discuss with your vendor is going to be key and imperative, not only to satisfy your specific requirements right now, but getting the validation together properly to further minimize rework.
还有什么需要添加的吗?
At this point, we are all in the same boat. Most of us are working from home and trying to stay safe, as well as keeping our colleagues at the manufacturing facilities, testing labs, etc. as safe as possible. Thus, taking one-step back and having all the information you need up front is key and critical in order to keep things moving forward.