The 2025 Kilmer Conference Next Generation Microbiological Quality and Sterility Assurance

The next Kilmer Conference will be held in Orlando, Florida, on February 3-6, 2025. For those unfamiliar with this conference, it was established in 1976 as a tribute to Fred B. Kilmer as the first chief scientific officer of Johnson & Johnson, an early pioneer in microbiological control and sterilizing medical products. The Kilmer Conference is unlike any other conference. It brings together global thought leaders in the spirit of collaboration to share challenges, science, and their visions to strengthen and evolve best practices for sterility assurance and microbial control in products.

My experience with the Kilmer Conferences has now come full circle. I started my career as a microbiologist in the food industry and then joined the medical device sterilization community over 30 years ago. At that time, I had limited sterilization experience and was eager to quickly get up to speed in this new discipline. Even today, very few sterility assurance courses and topics are available in the typical university curriculum, so we must strengthen our competency based on training, mentoring, “on-the-job” experiences and collaboration within our community.

At that time, I had an exceptional mentor (Dr. Casimir Woss) who actively supported my development in these ways but also recommended I contact Johnson & Johnson to obtain copies of the Proceedings of the Kilmer Conferences that were convened back in the ’70s and ’80s. The Kilmer Conference Proceedings helped me “cut my teeth” to develop and strengthen my competency with medical product sterilization — I still refer back to these proceedings regularly. Since that time, I have continued to gain experience through participation in the Association for the Advancement of Medical Instrumentation (AAMI), the PDA and other industry organizations and now actively contribute to the Kilmer Conferences as an industry advisory board member, planning committee member, speaker/panelist and collaboration team leader.

Upon the completion of the 2022 conference, Johnson & Johnson transferred sponsorship to AAMI and PDA, and these organizations have been partnering to develop the program for the 2025 Kilmer Conference. The conference agenda includes the latest developments on topics such as microbiological quality level, microbiological contamination control, alternative sterilization modalities, use of artificial intelligence and big data to improve programs, medical product packaging enhancements, novel microbial detection methods and approaches, sterilization process optimization, and other advancements on many other relevant topics.

Many industry conferences meet annually or frequently with limited focus on participant connection to ensure ongoing progression and tackle relevant challenges between conferences. To ensure continuous progress between conferences, the Kilmer Conference has established a portfolio of collaboration teams that work continuously between conferences to address the challenges for critical topics between the conferences actively. The current Kilmer Collaboration Teams include Sterilization Modalities and Material Compatibility, Microbiological Quality Process Analytical Technology, Parametric Release, Kilmer Innovations in Packaging and Regulatory Science. The rosters of the collaboration teams include global industry and regulatory experts. For example, the U.S. Food and Drug Administration Center for Devices and Radiological Health branch has recently granted formal recognition of the Kilmer Collaboration Teams as a collaborative community, confirming their ongoing participation and support of this effort.

To ensure the success of the Kilmer Conference, the Kilmer Patron Program has been established to provide an opportunity for medical device, pharmaceutical and other companies to make contributions to ensure sustainability of the conference and the evolution of sterility assurance and microbial control practices for many years. Further information on the Kilmer Patron Program can be found at Patron Program | AAMI.

Onsite participation at Kilmer Conferences is limited and available by invitation only to provide an environment uniquely conducive to ensuring active participation in technical discussions. However, the conference's video streaming is available to everyone with registration using the following link: Kilmer Conference Live Stream | AAMI. The Kilmer Conference also features a single track to promote a focus on the topic without distraction for the virtual and onsite participants. In addition to live streaming of the conference, video and text proceedings from previous conferences are also publicly available without charge at Conference Proceedings | AAMI.

I highly recommend the Kilmer resources provided above and participation in the 2025 Kilmer Conference for anyone with a general or developmental interest in sterility assurance and microbial control—Kilmer has truly had a tremendous impact on my development and my resulting successful career.