Packaging considerations should be made early during the product development process, advises members of the Sterilization Packaging Manufacturers Council (SPMC) of the Flexible Packaging Association. Members of the SPMC’s Technical Group spoke during the Webcast, “Sterilization: A Sterile Packaging Perspective,” covering the impacts that different sterilization methods have on medical packaging materials and what to consider when developing such packaging.
For engineers to begin to understand how packaging materials respond to sterilization, Marie Tkacik, Director of Product Development and Optimization of Beacon Converters, urged attendees to start with AAMI TIR 17 and its annexes as well as ISO 11607 and AAMI TIR 22 currently under development as ISO 16775, which lists 11 different sterilization methods.
“These standards are important references to help start the decision-making process, but they are not the end point,” Tkacik explained. “Including your packaging supplier early, such as during the developmental stages of your product, can improve the process and create a list of options to enable sterilization and the maintenance of sterility.”
Tkacik spoke along with fellow members of SPMC’s Technical Group who discussed specific sterilization methods. Geoff Pavey, Sr. Principal Engineer, Packaging Development, Oliver-Tolas Healthcare Packaging, spoke about EtO; Dr. Henk Blom, Director of Technical Services, Rollprint Packaging Products Inc., spoke on radiation; and Christopher Osborn, Vice President of Research & Development, Perfecseal Division of the Bemis Company, spoke about autoclave, steam, dry heat, and alternative methods such as pulsed white light, chlorine dioxide, x-ray, ozone, and Vaporized Hydrogen Peroxide.
Interestingly, many Webcast attendees who responded to a live poll during the event already appear to be following SPMC’s advice to start early. When asked at what point in the medical device development process they consider package design and materials, half of the respondents reported they do so “during the prototyping/development process.” And 36% are considering packaging even earlier, “when gathering inputs/requirements” during “Voice of the Customer” activities. Just 10% are doing so “at the time of design verification/validation,” and only 4% are doing so just “prior to launch.”
Tkacik says that "it is encouraging to see the polling result. The earlier we are involved in the developmental process, the better. A package designed well provides a high degree of value to the finished product. We need to be available to that 4% and encourage them to include their packaging and material suppliers, too."
Engineers should consider packaging early, because as Osborn stated during the Webcast, the “sterilization method is critical to quality requirements for packaging design and material selection.” Consequently, packaging engineers should work closely with material and packaging suppliers throughout the design process,” he added. “Make sure materials are fit for and compatible with sterilization methods, and protocols should be designed to assess the effects of sterilization on packaging materials. You really want to be able to document what happens to material through sterilization process.”
The group also addressed several questions during the live event, and they will share those answers as well as tackle unaddressed questions under the FAQ section of its Web sitewww.sterilizationpackaging.org.
