Dr. Daniel Norwood Discusses Biocompatibility Standards and The Future of E&L Testing

Q: What are some of the most interesting solutions that are impacting extractables and leachable industry standards at this time?

USP standards related to packaging systems continue to be developed and evolve.  In particular, USP<231> related to rubber components is currently being revised and will soon appear in the PF.  USP general chapters related to biocompatibility, including USP<87> <88> and <1031>, are also being revised and will also appear in the PF within the next year.  The ISO 10993 Part 18 guidance for medical device chemical assessment is being revised and has the potential for impacting packaging system development through the recent involvement of CDRH.  It will also be interesting to see how CDRH chooses to apply ISO 18562 to packaging systems for combination products, particularly inhalation.

Q: As end users continually push for more cost-effective and faster solutions, what do you think is the biggest concern regarding extractable and leachable testing as it relates to chemical safety qualifications?

In my view, the biggest challenge continues to be uncertainty within the regulatory authorities regarding the application of ISO biocompatibility guidances (ISO 10993 and ISO 18562) along with their lack of acceptance of the PQRI PODP recommendations related to the Cramer Classification system with its variable safety thresholds for leachables as a function of compound type.

Q: If you could have immediate access to one thing on your regulatory wish list in regard to industry standards, what would you choose and why? How would access to this solution help you to reach your business goals?

The ISO biocompatibility standards are quite expensive to access, so I would choose them. Detailed knowledge of ISO standards is essential for an expert in extractables/leachables pharmaceutical development.

Q: What does USP hope to achieve over the next 5 years with regards to the future of extractable and leachable testing?

In particular, over the next 5 years USP would like to:

  • Publish revised and modernized biocompatibility standards and guidance;
  • Publish revised and modernized elastomer standards;
  • Implement the revised plastic standards;
  • Continue to evolve extractables and leachables guidance chapters, extending to all dosage forms;
  • Consider pharmaceutical metals standards.

Q: Your workshop at this year’s E&L USA will cover biocompatibility. Why is it important for others in your industry to better understand this area of expertise? What are some of the key take-aways?

As noted above, biocompatibility standards and guidances are currently being revised and modernized.Detailed understanding of these guidances and the current practice of biocompatibility testing is essential for any pharmaceutical development scientist dealing with packaging systems and extractables/leachables. The workshop will focus on the knowledge needs of analytical chemists in particular, with the goal of understanding what biocompatibility testing is, where and how it is applied within a quality risk management system, along with appropriate details of the actual testing.


Are you interested in hearing more about the regulatory uncertainty surrounding biocompatability testing?
Book your ticket to join us at Extractables and Leachables USA this May and be sure to add the Pre-Conference Workshop to hear directly from Dan during - Chemical Safety Qualification and Biocompatibility of Packaging Systems and Medical Devices “An Analytical Chemistry Perspective”  - taking place on the afternoon of Tuesday, May 7, 2019.