Medical Device Testing Laboratory

Open House to Celebrate Expanded and Upgraded Lab Facility in Itasca, IL

We are excited to share the news that our Nelson Labs facility in Itasca, IL significantly expanded lab operations and testing capabilities to better serve our customer needs.

Nelson Labs Itasca Open House 5-1-18 016Lab customers will benefit from state-of-the-art facility and equipment upgrades to the Itasca lab as well as over 10,000 square feet of building expansions and renovated lab space.

New Capabilities: New testing capabilities are online and fully operational since May 1, 2018. These testing services include medical device particulates, healthcare reprocessing validations, sterilization for reuse validations, and genetic microbial identifications.

Expanded Capacity: The previous test offerings of this lab facility are still available with the additional benefits of increased lab capacity for bioburden tests, radiation validations, bacterial endotoxin testing (BET), and product sterility testing.

BET 2Fully Accredited: The Itasca lab facility is now ISO 17025 accredited and under the same robust quality system as the global Nelson Labs headquarters in Salt Lake City.

Improved Study Access: Customers are now able to track their submitted studies and retrieve test reports via the Nelson Labs’ Secure Customer Portal.

To read the full press release, click HERE.

Earlier this week, we celebrated the exciting expansion and upgrades by hosting an Open House at the Itasca facility. Among those in attendance were leadership from Nelson Labs and Sterigenics, customers, vendors, and the Mayor of the Village of Itasca with some of his staff.

Attendees were able to tour the laboratory and learn about the history of the facility from Director of Laboratory Operations Mike Rahn and other laboratory staff. To schedule a tour, please contact our Service Center.

Healthpack Conference 2018 Wrap Up

By: Wendy Mach, RM (NRCM), CQA (ASQ)

This year’s Healthpack® Conference included a wide range of topics and speakers that covered everything from the past, present, and future of the packaging industry. With a majority of the attendees being from both the medical device manufacturers and material suppliers, the opportunities to share and learn were plentiful and exciting.

This year’s highlights included the always popular Nurses Panel.  Manufacturers have the opportunity to subject prototype packaging to local nurses and, through a moderator, listen to their interaction and comments as they open the units. The biggest takeaway for this year was a “dislike” of locking dispenser boxes that frequently lead to difficulties opening the packaging, and the opportunity for finger cuts when opening.

The industry survey included questions on packaging that related to a company’s focus, what types of packaging tests most companies perform to meet the ISO 11607 regulations, and how packaging fits into a company’s organization. It was clear to see from the responses that the focus and awareness of packaging in the medical device industry is growing but still continues to be considered one of the last steps in the design process.

As the European Union (EU) prepares for the update of the Medical Device Regulation (MDR) to be fully implemented in May 2020, a thorough review of the implementation dates, changes to be expected and the impact to sterile packaging was discussed.  As the due date approaches, the AAMI Packaging group (ISO TC 198/WG7) is working diligently to bring the ISO 11607 document into alignment with the MDR regulations.

One of the most interesting topics presented was Smart Packaging and its possible uses for the future.  With the increase of available conductive inks, the possibility of capturing real data throughout a package lifecycle is not just a possibility – but a reality.  This data can be used in so many ways from remote sensing to interoperable communication.  Envision a device label that can provide real time data to a device manufacturer regarding the actual distribution environment it traveled. The development of test cycles could be based on real data rather than established standards that represent worst case situations; this actual usage data can represent extreme conditions for many companies.

Other topics covered included a very informative discussion on material selection with regards to flexible packaging, a panel discussion on seal strength testing, and the FDA regulatory perspective with regarding to sterile barrier testing.  Last but not least was a discussion of seal strength differences between EN 868 and ASTM F88.

Overall, everyone walked away from this year’s conference with a background of where the packaging industry was, what is currently being worked on, and then a glimpse of what the future may hold.