Kilmer Conference

(a)Introduction and Background

Johnson & Johnson hosted its 10th Kilmer Conference in Dublin, Ireland, June 3–6, 2019. The event is a premier global forum focused on sterility assurance and sterilization for invited professionals from industry, academia, government agencies, and healthcare delivery organizations. The theme of the conference was “Collaborate to Innovate.”

The conference series is a memorial to Fred Kilmer, director of the company’s scientific laboratory from 1889 to 1934. Johnson & Johnson held eight Kilmer Conferences from 1976 to 2003 before reviving the event in 2016.

The 2019 Kilmer Conference program was designed to be both motivational and inspirational, and delivered content focused on evidence-based, innovative practices to foster collaborative approaches within the sterility assurance community. Kilmer is designed to be a forward-looking exchange of ideas and new approaches throughout the conference will help sterilization professionals prepare for future advances in science and technology that will enable end-to-end sterility assurance to advance patient safety.

(b)Kilmer 2019 - Report

This Report will focus on topics and matters discussed at the conference and specifically on matters related to terminal sterilisation and/or manufacturing and technology developments and trends. Approximately 300 people were in attendance with the majority coming from North America and Europe.

For the last 12 months iia has been supporting Arthur Dumba in developing a Competency Framework for Sterility Assurance Professionals. This resulted in the formation of a Working Group known as the Society for Sterility Assurance Professionals (SfSAP). The Working Group includes representatives from iia, BD,

Abbott and ASTM. Members of the SfSAP have also been working to ensure that AAMI becomes involved and have also been liaising with the Irradiation Panel and its working groups. As a consequence of these actions the SfSAP steering group prepared a Poster for presentation at Kilmer. The Poster received a Best Award at Kilmer.

Several years ago the iia supported GIPA in producing a White Paper– A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products

The White Paper highlighted that approx. 45% of terminal sterilisation is undertaken using irradiation. Whilst this remains the case there is a growth in the manufacture of niche and small volume products. The conference considered issues surrounding innovations in sterility assurance, additive manufacturing, 3D printed bioresorbable patient specific implants and new technologies. A growing number of new products are patient specific with the result that new validation and processing procedures and protocols need to be developed. Patient specific products are well suited to in-line/small batch sterilisation modalities where manufacturing and transit times are critical.

Healthcare companies are often involved in the manufacture of medical devices, pharma products and consumer goods where product lines and categories are often becoming blurred. Irradiation sub-contract service providers are an extension of the manufacturing process and need to be able to provide comprehensive technical advice on materials and the choice of sterilisation modality in order to remain relevant, and to establish strong working relationship with device manufacturers.

The healthcare community are shortly publishing “Assurance of Sterility for sensitive Combination products and Materials” this is defined as a new paradigm to bring innovation to healthcare products and patients. The publication includes chapters on: Terminal Sterilisation, Aseptic Processing, Packing / Containers and Closures, Preventing Health Care Associated Infections, Risk to patients, Developing New Products and Regulatory Pathways. Further details are available in the following image.

Richard Cowman (STERIS) gave an interesting presentation on EO processing. In 2012 WHO IARC defined EO as a Class 1 carcinogen and in 2015 ANSM set out the specific conditions relating to the sale and distribution of certain medical devices sterilised using ethylene oxide. This has been further reinforced by growing concerns over occupational and patient exposure and increased scrutiny of EO residual emissions. As a consequence of the above STERIS have developed a scorecard that places cycles into one of 6 categories. It was found that that average cycle had emissions of 600 mg/L which STERIS used to define the 2nd highest category on the scorecard. The objective of the initiative was to develop new cycles that lower the emissions without compromising sterility assurance. This exercise has, to date, resulted in most cycle concentrations being reduced from an average of 600 mg/L to 362 mg/L. The new cycle designs are now being validated and introduced.

Tony Faucette (BD) and Mark Murphy (PNNL) presented work on an Industry Collaboration to Fill Data Gaps in Material Effects for Medical Polymers. We understand that this is a project that has been initiated by National Nuclear Security Administration (NNSA) who are funding the initiative. The aim being to make it easier for medical device manufacturers to change from using gamma to Eb or X-ray for sterilisation.

The initial study was undertaken using two BD products which are currently sterilised using gamma technology. The two products were the vacutainer and the push button blood collection set.

The initial results were presented covering a comparison between gamma, electron beam and X-ray. No adverse results were found. The project is ongoing.

The use of parametric release was referenced in a number of presentations and is clearly a topic of interest. In this regard computer modelling was also discussed in a number of presentations.

Several groups which came together to create the Kilmer program will continue to collaborate and have established mid and long-term goals. These include initiatives such as the iia sponsored SfSAP as well as training programs and novel technologies.

Longer Term Aims

The technologies referenced included: radiation (gamma, Eb and X-ray), EO, Moist Heat, Dry Heat, Hydrogen Peroxide, Nitrous Dioxide, Chlorine Dioxide as well as Aseptic manufacturing. There was reference to Viral Vector Manufacturing where products are kept at < -60C with sterilisation using filtration. Another was Spray Freeze / Dynamic Freeze Drying (F@ST) Freeze Drying at Source Technology where products are treated at -130C. In the case of CAR-T (Chimeric Antigen Receptor “T” cells are modified to look like cancer cells in blood allowing patients own immune

systems to fight cancers necessitating novel sterilisation technologies. Speed to patient is increasingly critical requiring cryogenic shipping networks and zero inventory – all of this is a long way from traditional sterilisation of large batches of simple medical devices. The developments appear to be in patient specific high value niche products.

Johnson and Johnson are clearly providing a great service to the sterilisation and healthcare community by taking the initiative to re-introduce the Kilmer conference and to facilitate collaboration and innovation.