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most recent messages 5/24/2013 5:08:45 AM Rolande Hall Sorry folks, I crossed over my voltages! Ireland was at 220V and is now at 230V. European Standardisation is at 230V not 220V. For voltages and frequency country by country go to https://en.wik... blog roll message boards chat High Altitude as a Distribution Hazard Rolande Hall, FIMMM Pkg Prof, 5/24/2013 Comment now The majority of sterile medical devices are transported by air or sea or rail; all will travel by road for at least part of their journey from manufacturer to the eventual user. Survey: What Keeps You Up at Night? Stephanie Wiseman, Community Editor, 5/22/2013 Comment now Designing medical device packaging is challenging. There are dozens of issues at any given time: design, sterilisation, material choice, labelling, end-user experience, and the list goes on and on. It's enough to cause a sleepless night or two. Innovation ≠ Invention Dan Formosa, Ph.D., 5/22/2013 Comment now 4 comments A few weeks ago, I had a chance to spend a few days in rainy, wet London. The purpose was to attend an event at the Royal College of Art on design and healthcare. The "Smart Salon" was hosted by RCA's Helen Hamlyn Centre and my office, Smart Design Barcelona (hence the name). Most recent post, Stephanie Wiseman, 5/22/2013 2:12:56 PM This is where end user market research and usability studies are essential. Everyone... Sealing Machine Issues Rolande Hall, FIMMM Pkg Prof, 5/21/2013 Comment now 6 comments When a company buys several machines of the same type for different locations, it might be forgiven for expecting the same parameter settings would be needed in each location. Sometimes the company will ask, "All our machines are the same. Can we just validate a sample?" Most recent post, Rolande Hall, 5/24/2013 5:08:45 AM Sorry folks, I crossed over my voltages! Ireland was at 220V and is now at 230V.... Can Package Design Help MDMs Create Market Share? Stephanie Wiseman, Community Editor, 5/20/2013 Comment now 11 comments We all know package design creates market share in the food and cosmetic industry. And if you are the industry leader, "knockoff" brands often try to imitate your design so consumers will associate you with the less-expensive brand and buy the other brand because if the packaging is the same, quality of product is the same. Most recent post, Thierry Wagner, 5/23/2013 2:44:06 AM ...very interesting discussion! I agree, packaging can make a huge difference. There 2... Why Are We Afraid of 'Private' User Insight Gathering? Adele Graham-King, Blogger, 5/20/2013 Comment now 2 comments Some time ago, while I was working within design but in a slightly different sector, a potential client discussed with me the possibility of undertaking user research in the personal care environment. This client specialised in bathrooms and was having great difficulty gathering user insights into toilet habits. At the time, the firm did not believe it ... Most recent post, Adele Graham-King, 5/20/2013 9:11:53 AM It's amazing isn't it! And I think you're right - unless you have close contact... Validated Label Materials Warren Ward-Stacey, Sales Director, Prisym ID, 5/17/2013 Comment now 2 comments In the medical device market, using the correct label materials is crucial. Using the wrong adhesive, label, or ribbon can result in noncompliance and labeling errors. Validation is not just about the materials. The combination of those materials is also important. Most recent post, Rolande Hall, 5/21/2013 4:10:42 PM Label printing and application systems must include a process for recording the... Developing a Stability Rationale for Shipment of Thermally Sensitive Products Karen K. Greene, CPP, Vice President, Life Packaging Technology, 5/16/2013 Comment now 1 Comment This blog will focus on packaging temperature-sensitive products (for this audience, combination products) as a follow up to the blog on developing a Center of Excellence for packaging engineering. Most recent post, Stephanie Wiseman, 5/16/2013 4:12:27 PM Karen, thank you for the practical guidance. The drug-device combo is going to become... French Hip Replacement Scandal: Could It Happen in Packaging? Stephanie Wiseman, Community Editor, 5/15/2013 Comment now 3 comments Still reeling from the PIP breast implant scandal, France is once again facing international scrutiny for allowing 630 people to be fitted with hip implants without European safety certification. Most recent post, Stephanie Wiseman, 5/16/2013 11:00:04 AM @tobias, I agree. I doubt if the changes were minor it would take 2 years to get... Stability Testing Simplified Hal Miller, President, PACE Solutions, 5/15/2013 Comment now 3 comments Following Noel Gibbons's blog on Ageing & Climatisation, I thought I would offer some of my thoughts on aging and stability testing. - Are package stability samples taking up too much storage space? - Can you get enough medical devices far enough ahead of time to do stability testing? - Do I performance-test the package system before or after ... Most recent post, Karen K. Greene, 5/15/2013 11:44:16 PM Hal, You make great points that package stability tesitng is about the performance... Notified Bodies Compete for Business Rolande Hall, FIMMM Pkg Prof, 5/14/2013 Comment now 2 comments Whilst browsing the Internet the other day, I came across the website of the National Standards Association of Ireland (NSAI). As it is marked "Copyright (C) 2009 NSAI," you might have seen it already. This page brought to mind a recent discussion with a client. Most recent post, Stephanie Wiseman, 5/15/2013 2:48:52 PM I agree, competition and freedom to "shop around" like you said is a good thing.... Next 5 blogs + All blogs All blogs most commented 11 Can Package Design Help MDMs Create Market Share? Stephanie Wiseman, Community Editor, 5/20/2013 6 Sealing Machine Issues Rolande Hall, FIMMM Pkg Prof, 5/21/2013 4 Innovation ≠ Invention Dan Formosa, Ph.D., 5/22/2013 2 Why Are We Afraid of 'Private' User Insight Gathering? Adele Graham-King, Blogger, 5/20/2013 blog roll message boards chat 5/24/2013 5:08:45 AM Re: Validation: Sorry folks, I crossed over my voltages! Ireland was at 220V and is now at 230V. European Standardisation is at 230V not 220V. For voltages and frequency country by country go to https://en.wikipedia.org/wiki/Mains_electricity_by_country.... Rolande Hall on Sealing Machine Issues 5/23/2013 10:46:08 PM Re: Great job!: That is so good to hear! Stephanie Wiseman on How Are We Doing? 5/23/2013 10:45:23 PM Re: Validation: Thank goodness for the standardisation change--how expensive it must be to make sure your equipment runs well under all those circumstances and how challenging to try and validate them all correctly. Too, maintenance and training issues must... Stephanie Wiseman on Sealing Machine Issues 5/23/2013 10:40:19 PM Re: Airline Packaging Failure: @Noel, I think you've also revealed another issue that we should discuss: listening to your lab. I'm amazed that the company didn't listen to the lab (they were paying to test their product!) when the lab did their job and found the problem. How... Stephanie Wiseman on Flying High & Package Failure 5/23/2013 10:34:21 PM Re: Airline packaging failure: Rolande, you are right! Look for it in coming weeks! Stephanie Wiseman on Flying High & Package Failure 5/23/2013 10:33:17 PM Re: Seal strength: Seal strength equates to maintained sterility. Without continuous sterilisation, the package is lost and the device can't be used. It's like a zipper, you don't realize how important one is until the one you have doesn't work and your pants... Stephanie Wiseman on How Do You Document Minimum Seal Strength? 5/23/2013 10:31:13 PM Re: Very useful: agreed! I often wonder, with the advances we're making what will packaging be like in 3, 5 and 10 years from now? How will it change and can we really start implementing these kinds of technologies? Stephanie Wiseman on Printable Electronics Monitor Has Uses in Medical Packaging 5/23/2013 5:01:18 PM Re: reusing single-use devices: The main issue is that since the devices are not meant to be re-used, there is concern that reprocessing the devices could lead to unintended consequences. There is limited data on this, so we don't know exactly how SUDs are effected by reprocessing.... Camilla Andersson on Draft Report on New EU Device Regulation Seeks to End Reprocessing of Single-Use Devices 5/23/2013 4:48:20 PM Re: reusing single-use devices: For me it's about sterilisation and device design. A device designed to be used once may not be effective (e.g.) delivering the medicine on the second or third use. Stephanie Wiseman on Draft Report on New EU Device Regulation Seeks to End Reprocessing of Single-Use Devices 5/23/2013 4:23:21 PM Re: Validation: Another good question Cathy. In the US the single phase voltage is 110 at a frequency of 60Hz whilst in Europe there was a spread of voltages but we are standardising at 220 volts and 50 Hz. Ireland was at 230 volts and the UK at 240 before... Rolande Hall on Sealing Machine Issues 5/23/2013 3:57:02 PM What do you think?: A great article from healthcarepackaging.com: UDI: Bane or benefit? You decide What are the broader implications of UDI in your organisation? Stephanie Wiseman on What do you think? 5/23/2013 3:39:51 PM Airline packaging failure: We have all been writing about inflation leading to packaging damage. We should not overlook that returning to lower ground from a high altitude may also lead to packages and contents being crushed. One example, brought to my attention recently,... Rolande Hall on Flying High & Package Failure Next 5 messages + All messages All messages blog roll message boards chat 5/10/2013 3:08:15 PM Medical Device Packaging: Standard Changes in Dye Penetration Testing : RE: Why does ASTM publish test methods with what might be considered a low precision % ? The philosophy of ASTM Committee F02 is that a test method is what it is, and provides the users with information to make their own decisions on... Stephanie Wiseman Blogger 5/10/2013 3:07:49 PM Medical Device Packaging: Standard Changes in Dye Penetration Testing : RE: Do you need to validate the test method or just use ASTM data? A: YES, you MUST validate you test methods. ASTM provides you with the defect sensitivity level and target precision values for you own validation criteria. ... Stephanie Wiseman Blogger 5/10/2013 3:07:19 PM Medical Device Packaging: Standard Changes in Dye Penetration Testing : RE: What is the time frame for the nonporous test for foil? A: We hope to ballot the injection method in the fall with publication next year. However, there is no reason why you cannot validate the method now to a 50 micron channel... Stephanie Wiseman Blogger 5/10/2013 3:06:51 PM Medical Device Packaging: Standard Changes in Dye Penetration Testing : RE: Will the methods work with knurled or multi-line seals? A: If there is a clear channel, the dye should work with either of those seal configurations. Stephanie Wiseman Blogger 5/10/2013 3:05:59 PM Medical Device Packaging: Standard Changes in Dye Penetration Testing : RE: What method works better with paper pouches? A: Either the injection method or the edge dip method should work just fine. A paper pouch was used in the interlab studies successfully. The dye acts via capillary action up,... Stephanie Wiseman Blogger 5/10/2013 3:00:03 PM Medical Device Packaging: Standard Changes in Dye Penetration Testing : For those who mentioned the audio quality, I will speak to our vendor and try to resolve the issue before our next one. Stephanie Wiseman Blogger 5/10/2013 2:51:43 PM Medical Device Packaging: Standard Changes in Dye Penetration Testing : thanks for the presentation! I enjoyed. iacovacci Key Contributor 5/9/2013 11:12:58 AM Medical Device Packaging: Standard Changes in Dye Penetration Testing : Thanks for the presentation. I was very interested in the commentary about folding peel pouches. Not ideal but a very common practice, I gather, including my own company. Based on a previous article on this site, I kicked... paul.molloy Key Contributor 5/9/2013 10:19:02 AM Medical Device Packaging: Standard Changes in Dye Penetration Testing : I was unable to listen to the live presentation, however the audio on the site seems very poor Regards Pete Great Bear Key Contributor 5/9/2013 10:06:57 AM Medical Device Packaging: Standard Changes in Dye Penetration Testing : Thank you for providing this information & Radio Chat to our Medical Device community. Greatly appreciated. Steve MedStar Key Contributor Next 5 chats +		search MPI Search by: Blogs Messages message boards Have a question, blog idea or topic but don't want to write a blog? Post it on our message boards and get feedback from our editors and the community digital audio Latest Archived Broadcast Medical Device Packaging: Standard Changes in Dye Penetration Testing Maintaining seal integrity is a high priority in medical device packaging, therefore, testing standards need to be relevant and applicable. Listen Archived shows Download to calendar flash poll All polls featured content Adjusting Internal Processes for the UDI Rules in the EU Infographic: The Medical Device Outsourcing Landscape: Current and Future Trends Packaging Europe: Pharma & Medical Trends in Pharmaceutical Packaging Interview with Eucomed: A New Direction in Medical Labeling All featured content information resources sponsored content by DuPont Non-Limitative Overview of EU Legislation Relevant to Medical Device Manufacturers Chemical Resistance of DuPont™ Tyvek® How does Tyvek® compare to paper? - Go to the DuPont Technical Reference Guide for more information What Properties have been measured on Tyvek®? - Check out the DuPont Technical Reference Guide DuPont™ Tyvek® compliance to ISO 11607-1:2006 Webcast: DuPont Medical Packaging Transition Project Is your packaging material and design appropriate for your application? DuPont™ Tyvek® Easy-Opening Packaging Systems Video: DuPont™ Tyvek® and sterile medical packaging Video: DuPont™ Tyvek® in different packaging technologies All resources

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