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.

Accelerated Aging Package Testing

By: Pal Khangaldy & Wendy Mach

The Packaging Department at Nelson Laboratories is often asked by manufacturers “What do I need to do to validate my packaging?” or “What package testing do I need to have performed in order to comply with regulations?” There is not a one-size-fits-all answer to these questions as unique product, packaging, and sterilization combinations require unique testing combinations. However, there are some basic testing concepts that apply to all product and package types: expiry testing; strength, integrity, and microbial barrier testing; and package distribution testing.

FDA and Accelerated Aging

ChamberFDA requires testing to demonstrate that the packaged product will maintain its integrity and sterility when stored over time, and this testing is required to establish an expiry date. Tests that meet these regulatory requirements are accelerated aging testing, real-time aging testing, or a combination of both. It is important to note that accelerated aging testing does not replace real-time aging testing. In a perfect world with unlimited time and resources, manufacturers would only conduct real time aging tests. However, this type of testing is not practical for manufacturers that need to quickly get their product on the market – they do not have the time to put a package system on the shelf for two or more years and await the results. Because of this, accelerated aging was developed as it meets the testing requirements by FDA.

Accelerated Aging Testing

The concept behind accelerated aging testing: Increasing the temperature escalates the chemical reaction rate of the samples and results in deterioration of materials which simulates artificial aging. Every 10°C increase in temperature doubles the reaction rate. This concept is based on the Arrhenius equation and is explained in further detail in ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Devices.

There are limits to this equation, as increasing the temperature too high can prematurely destroy the product/package system. Test temperatures should not exceed 60°C. The temperature used most often in the industry for accelerated aging is 55°C and is the temperature Nelson Labs recommends.

Next Steps

Strength, integrity, and microbial testing verify that the packaging is intact after aging tests. These types of testing are the topics of our next blog post. For more information on real-time or accelerated aging testing, contact your Nelson Labs Account Manager or our Service Center via ServiceCenter@NelsonLabs.com or 801-826-2088.

 

 

 

Nelson Labs’ Scientists Awarded Best Published Paper 2017

By: Daniel Olsen, M.S. SM(NRCM)

Nelson Laboratories scientists, Michelle Lee, Audrey Turley, and Daniel Olsen, in collaboration with scientists from the Japanese National Institutes of Health, recently published important research for the development of in vitro skin irritation testing for medical devices. Their article, “Proof of concept testing of a positive reference material for in vivo and in vitro skin irritation testing”, was published in the Journal of Biomedical Materials Research.

The article reports the discovery, development, and testing of the first available material to be used as an extractable positive control for in vitro irritation testing. The material is the first shown to elicit a positive irritation response in both polar and non-polar extraction solvents. This discovery of an extractable positive control material was a key step in the progress of in vitro skin irritation testing for medical devices and helped prepare the way for the recently completed international validation of the irritation test method.

The article was awarded the Best Published Paper honor for 2017 from the Medical Device and Combination Products Specialty Section (MDCPSS) of the Society of Toxicology (SOT). MDCPSS is composed of many experts within the medical device industry including a dynamic mix of scientists from device manufacturing companies, contract research organizations, regulatory agencies, and consulting companies. The award will be presented in March at the 2018 SOT Annual Meeting in San Antonio, TX.

Martell Winters is Convener for ISO WG16

martell_winters_3It was recently announced that Martell Winters, B.S., RM/SM(NRCM) was appointed and approved as convenor for a three-year term of a new ISO working group, WG16, on vaporized hydrogen peroxide sterilization. The new working group is tasked with developing a new standard to provide requirements and guidance for developing sterilization processes for vaporized hydrogen peroxide. The ISO document has been named ISO 22441, Sterilization of healthcare products – Low temperature vaporized hydrogen peroxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.

“I’m honored to be considered and appointed as convenor of WG16,” Martell said about the appointment. “I look forward to working with the members of the group as we develop this new standard. There are a good number of experts in vaporized hydrogen peroxide involved, so I am confident that our efforts will result in a technically correct and useful standard.”

Previously, vaporized hydrogen peroxide sterilization was addressed under the general sterilization criterial standard, ISO 14937, which provides general requirements for any sterilizing agent which does not already have a specific standard. It was felt by the international community that vaporized hydrogen peroxide had gained enough acceptance and use in the industry that it merited having its own standard.

The US body which will be participating in this ISO working group will be AAMI WG16, which is also a new working group and is currently being established. Anyone who has interest in being involved with this new AAMI working group should contact AAMI.

Cytotoxicity Failure Program

Cytotoxicity Failures

Cytotoxicity testing is designed to demonstrate if there are cytotoxic leachable substances from medical devices or materials. Cytotoxicity testing is the most sensitive biocompatibility test and is used for safety testing of all medical devices with patient contact.  It is also used frequently as a routine screening test for raw materials.

Occasionally, a device or material will exhibit a level of cytotoxic reactivity that is higher than what is allowed by the ANSI/AAMI/ISO 10993-5 standard and will result in a failed test. Although your product may have failed a cytotoxicity test, it doesn’t necessarily mean that your device or material is unsafe for clinical use. It simply means that you are obligated to identify the source of the failure and assess any toxicological risks. There are several possible causes for a failure, and Nelson Labs provides services to help you assess the failure and any toxicological risks.

Cytotoxicity Failure Program

Reconstructed human epidermis (RHE) for in vitro skin irritation and sensitization testing.

In the past, if your product failed cytotoxicity testing, you would need to send new samples for additional testing to determine the cause of the failure. We have recently added a new service to help our customers potentially save time and money when conducting these evaluations. If you request the Nelson Labs Cytotoxicity Failure Program when submitting your samples to the lab, we will store a sample of the extraction fluid from your cytotoxicity test until you receive your test results. In the case of a failing result, we will connect you with one of our subject matter experts who will help you develop a plan for investigation. Because we have retained a sample extract from your original cytotoxicity test, we can quickly test the retained fluid without the need for a new sample. We typically test for metals in these cases, as the presence of metals from the manufacturing process, handling, or colorants is a primary cause for failed cytotoxicity tests.

If the test detects cytotoxic metals in the extract, we will then contact you with details regarding initiating a toxicological risk assessment. Our toxicologists can assess the metals and determine if the concentration would be sufficient to lead to any patient safety issues. This analysis can also be helpful to decide if an investigation regarding the source of the contamination should be conducted.

The cytotoxicity test is a highly sensitive toxicity assay which is designed to determine if there are cytotoxic leachable substances or surface contaminants present in medical devices or raw materials. It is required testing for most medical devices and is used frequently as a routine screening test for raw materials and cleaning validations.

There are several possible causes for a failure, and Nelson Labs provides services to help you assess the failure and any toxicological risks.

If you would like to discuss this program, contact your Account Manager or sales@nelsonlabs.com.