DuPont Medical and Pharmaceutical Protection has announced that Nelson Laboratories will serve as the independent testing laboratory that will generate the data justifying the manufacturing transition of Tyvek 1073B and Tyvek 1059B to DuPont’s latest flash-spinning technology. Nelson Labs will conduct pre- and post-sterilization evaluations of all pouches and header bags, flexible and rigid blisters, and rigid tray-and-lidding combinations provided by medical device manufacturers involved in the transition protocol, which FDA approved in March 2011.
Approximately 60,000 packages are expected to be evaluated during the protocol. Testing will include visual inspection, package integrity using ASTM F1929, seal-strength testing using ASTM F88, and microbial barrier testing using ASTM F2638. These packages will also be studied after accelerated aging using ASTM F1980-07 and real-time aging, both at 1-, 3-, and 5-year intervals. The testing program is expected to last for up to 10 years.
Nelson Labs was chosen because of its breadth of capabilities and its quality system, explains Bruce Yost, global technical director, DuPont Medical and Pharmaceutical Protection. “Nelson conducts a diversity of packaging tests, including microbiological studies. The company also is proactive about using quality in everything it does, which was a significant selling point. Finally, its deliverables are very cost competitive.”
DuPont had worked with Nelson Labs previously, but decided to consider a number of global testing companies that could handle the magnitude of the Tyvek transition. After narrowing its options to four companies, which included Nelson, DuPont asked for proposals and conducted onsite visits to see facilities and meet staff. DuPont’s team assessed all proposals against specific criteria and unanimously selected Nelson.
The transition project comes at a “good time” for Nelson Labs, says Jeff Nelson, president and CEO. “We have just recently added 12,000 sq ft, which provides the flexibility for us to manage the project. A project of this size and scope could be daunting. But we have the space, equipment, team, service commitment, and quality in place to serve DuPont and the industry. And we will still be able to service our existing customers and new customers without disruption. We are proud to be selected and excited to work with a global leader like DuPont.”
Over the past four years, Nelson Labs has invested $25 million in growth. In 2010, it also added 50,000 sq ft dedicated to laboratory testing. “We have made a strategic plan to support this 10-year project as well as to invest beyond its scope,” says Nelson. “We continue to build in order to service existing and new customers, too.” This investment includes ongoing staff training, which Yost says is key for the 10-year program.
DuPont will also consider having Nelson perform additional testing outside the FDA-approved Tyvek transition protocol. DuPont is running what it calls its “phantom protocol,” which Yost describes as a “bucket for all other tests not covered in the first protocol. It includes evaluations for steam and low-temperature sterilization, bubble leak testing, and other requests from medical device manufacturers.” DuPont is also managing what it calls “product stewardship work,” which includes tests for biocompatibility and cytotoxicity and others to support global regulatory compliance.
“We do expect medical device manufacturers to embrace the work DuPont is doing, but some may want to go further,” says Nelson. “We are excited to help even beyond the scope of the protocol, which we can do because we offer more than 400 different tests.”
Nelson may actually start such work on tests outside the FDA-approved transition protocol because DuPont is on track to begin phantom protocol and product stewardship work within the next month. “We need to generate this data as a prelude to using Tyvek 1073B and Tyvek 1059B produced with the latest flash-spinning technology,” says Yost.
Package samples using this new Tyvek 1073B and Tyvek 1059B are scheduled to be manufactured in the second half of 2012. Testing of these samples is scheduled to begin in early 2013. “We are on track and on time with the project,” says Yost. “Both organizations are pleased with the proceedings so far.”
Adds Nelson: “We have already had several productive meetings to ensure that we have the right equipment in place as well as the components to maintain sample traceability.”
Given Nelson Labs’s 26-year history, the firm already had considerable testing experience and has even participated in the development of industry standards. ASTM F2638, Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier, is a newer standard, however, so DuPont and Nelson are working hand in hand to execute it, says Yost. This test method employs particle counters and an aerosol of polystyrene spheres to measure the filtration efficiency of porous materials rather than actual microbial spores.
“Part of the plan is to ensure Nelson is comfortable with ASTM F2638,” Yost adds. “But Nelson has done its homework on the method and is well prepared to learn.”
“We are excited for the opportunity to learn about ASTM F2638,” says Nelson. “Our experience in developing tests for packaging and microbiology as well as for barrier gowns and drapes gives us the depth to take a method like this and ensure our process is robust, precise, and consistent.”
DuPont’s latest flash-spinning technology and production lines at its Richmond, VA, and Luxembourg facilities will be used to produce Tyvek 1073B and Tyvek 1059B. DuPont Tyvek 2FS and Tyvek Asuron are already produced with the new flash-spinning technology on one of the lines. The transition protocol is designed to demonstrate that Tyvek 1073B and Tyvek 1059B made with the newer flash-spinning technology are functionally equivalent to those produced using previous technology.
Yost spoke in a Webcast on April 4 on the transition along with Mike Scholla, global regulatory director, and Thierry Wagner, regulatory affairs director, MPP EMEA, both with DuPont Medical and Pharmaceutical Protection.
DuPont has been producing Tyvek 1073B and Tyvek 1059B with 40-year-old flash-spinning technology. DuPont is investing $30 million in the transition, most of which will be spent on significant development efforts and the testing protocol. For more details, visitwww.medicalpackaging.dupont.com.