Medical device packaging professionals are well acquainted with ISO 11607, Parts 1 and 2. But how about ISO 10993-18?
ISO 11607 has guided medical packaging development for about two decades. The standard “outlines the requirements for both packaging materials and the sterile barrier package system, including physical, barrier, chemical, biocompatibility, and toxicological attributes for materials as well as performance testing for the package system,” explains Wei Zhang, Ph.D., senior research scientist on AMRI’s Extractables & Leachables and Impurities (ELI) team.
Medical packaging engineers should also consider ISO 10993, particularly the upcoming revisions, Zhang believes. “The biological safety attributes of medical devices are regulated by the ISO 10993 series, which cover a broad scope of safety evaluations through a variety of means including in-vitro and in-vivo biological evaluations, chemical characterization, and risk assessments,” he tells PMP News. “Since packaging materials that contact a medical device can transfer chemical constituents to the device, followed by an indirect exposure to the patient or user, the potential for introduction of contaminants from packaging materials should be considered.”
Zhang and Frank Bieganousky, director, package and medical device testing, Whitehouse Labs, a division of AMRI, will be speaking in the November 9th MD&M Minneapolis 2017 presentation at Center Stage, “How to Prepare Your Medical Device Packaging for a Regulatory Submission.” Attendance is free to all expo visitors.
Zhang says that “the upcoming revisions to ISO 10993-18 provides the framework for chemical characterization to offer significant utility in biological evaluations and toxicological risk assessments. As a result, chemical characterization activity of the medical device packaging is able to address many regulatory questions.”
For instance, “the chemical characterization information, either collected through information gathering or generated by chemical analysis, can be used for many important applications such as to support overall biological safety evaluations and to assess allowable limits of potential hazardous leachable substances,” he explains.
Such studies include evaluating packaging materials for the risks from extractables and leachables (E&L). “When generating chemical characterization information, a well-designed E&L study program provides key information on leachable substances that may be delivered to the end-user through direct or indirect exposure,” Zhang says. “A comprehensive E&L study must take into consideration materials, extraction conditions, extraction solutions, appropriately derived analytical evaluation threshold (AET), and the use of an adequate set of analytical techniques to cover the scope of potentially concerning leachable compounds.”
Zhang and Bieganousky will share some of the steps that should be taken when designing and carrying out a package qualification program, including a holistic determination of suitability, safety, and functionality, with focus on the evolving area of extractable/leachable testing.
Please join Zhang and Bieganousky at MD&M Minneapolis Center Stage November 9 at 11:15 am.
And to attend the co-located conference program at MD&M Minneapolis/MinnPack/Plastec Minneapolis, please use discount code PACK for 20% off.