The AAMI/Kilmer Industrial Sterilization Webinar Series will focus on topics related to sterilization process optimization, novel technology development, and guidance on sterilization best practices. This webinar series is the result of collaboration between sterility assurance professionals at the 2019 Kilmer Conference who came together to answer the question—How do we simplify sterilization modality changes and process optimization?
In response, the collaboration team identified the need for more publications, training, and guidance. This series follows two successful BI&T Industrial Sterilization supplements: “Process Optimization and Modality Changes” published in Summer 2020 and the recently published “Challenging the Status Quo, Driving for Continuous Improvement”. While the publications have presented new data and laid the groundwork for future standards and best practices, the webinar series is designed to provide recent, relevant and educational information to anyone wanting to learn more about these topics first hand from the industry leaders pioneering new methods and driving for change.
All webinars will take place from 1:00-2:00 PM ET. Register for the complete webinar series, and attend the sessions that interest you through the universal link included in your confirmation email. Recordings of all the webinars will be made available to registrants following the event.
Biotech drugs are the fastest growing segment of pharmaceutical and biotech pipelines. About 60-70% of these drugs are delivered in a pre-filled syringe or similar delivery device. Nitrogen dioxide sterilization offers an alternative sterilization method
with many advantages important for drug-device combination products. This webinar will address the sterilization challenges with pre-filled syringes, the advantages of nitrogen dioxide sterilization and the appropriate standards used for a nitrogen
dioxide sterilization validation. The speakers will also review a nitrogen dioxide sterilization validation recently completed by Sterigenics for a European biosimilar company.
Meet the Faculty:
David Opie
Annick Gillet
Terminal low temperature sterilization of heat and radiation sensitive medical devices is essential for achieving required sterility assurance for safe patient contact. Vaporized hydrogen peroxide (VHP or generally VH2O2) can deliver successful surface sterilization of medical devices under deep vacuum at low temperature conditions (28-50 °C).
This presentation explains the process principle and technology used in industrial VHP sterilization, essential process parameters, discuss material compatibility performance including any limitations, and provides information on various and typical applications VHP sterilization has already been used on during the past 20 years. Status of VHP (VH2O2) sterilization in context to ISO and CEN standards development, is also discussed.
Learning about the steps required for meeting regulatory requirements through successful validation of such sterilization equipment is crucial. This includes initial product feasibility testing, validation of the VHP sterilization process per current ISO 14937 standard, and cycle development for the specific sterilizer application. Requirements are set for establishing performance qualification for sterilizer equipment, process validation methodology and results, including appropriate process challenge testing, materials and biocompatibility of the medical device, proving repeatable and reliable performance of equipment delivering vaporized hydrogen peroxide to the chamber, by microbiological challenge studies using appropriate challenge organism, and establishing a PCD (process challenge device) for routine monitoring purposes (sterilization batch release in production). Cycle development, based on validation results, creates the cycle recipes used in routine production, verified by trial runs after successful installation IQ/OQ on-site the manufacturing facility.
Meet the Faculty:
Juha Mattila
Team Nablo was formed in 2018, and consists of over a dozen US and European representatives from medical and biopharma device manufacturers, contract sterilizers, eBeam and X-ray manufacturers, industrial R&D organizations, standards organizations
and academia. The team’s overall goal is to identify and fill data and education gaps for those considering transitioning from cobalt-60 sterilization. This presentation will cover the team’s progress so far, including measurements of
differences in polymer effects between the three irradiation modalities (gamma, eBeam and X-ray) for over a dozen different polymers, development of an online library for radiation effects on polymers, and development of a software package free to
users that allows calculation of dose uniformity ratios (DURs) for packaged polymer products (existing and in design phase) in eBeam.
Meet the Faculty:
Mark Murphy
Leo Fifield
A survey entitled Best Practice for EO Sterilization (BPEOS) was conducted in 2019 to provide a baseline understanding of current practice as well to identify best demonstrated practice with EO sterilization. This session will include a panel discussion
to provided interpretation and expound the results from the BPEOS Survey to drive a robust and informative discussion. The three esteemed panelists for this webinar represent a combined experience base of more than 100 years in the application of
scientific and practical approaches with EO sterilization. Topics for discussion by the panel include the most critical and potentially misunderstood elements of an effective and compliant EO sterilization program. Discussion topics include cycle
design approaches, development and validation of process challenge devices, recommendations for demonstration of the appropriateness of the EO BI, and EO product release programs with focus on considerations for the implementation of parametric release.
A time block will be reserved at the end of the session to address questions from the webinar attendees.
Meet the Faculty:
Mike Sadowski
Gerry O’Dell
Clark Houghtling
Varying motivations exist when endeavoring to optimize an established Ethylene Oxide (EO) sterilization process, such as the reduction of EO usage, lower emissions, easing capacity constraints, and improvement of occupational health and safety. This webinar details opportunities to improve an established EO sterilization process by evaluating multiple options including packaging and loading configurations, processing families, cycle parameters, and process equivalency across sterilizers and includes an overview of the regulatory pathway to follow when making such changes. Benefits of EO sterilization optimization may lead to increased product volume in a process load, reduced risk of process failures, reduced material degradation, reduced processing time and improved supply chain flow through EO facilities. In this webinar, each option is assessed for opportunities presented and includes regulatory aspects for managing an optimized EO process. While not an exhaustive list, the options presented are the base for “what-to consider” during stakeholder collaboration and alignment.
Meet the Faculty:
Melissa Escobedo
Dania Cortes
Marie Coyne
As a sterility assurance SME, do you feel as if decisions around sterilization modality selection are made without your input? Selection of a sterilization modality for a medical device is a critical decision that requires sterility assurance SMEs to work collaboratively with various company functions. This webinar will present several example situations where the sterility assurance SME input around sterilization modality selection may not be immediately apparent, and consequently overlooked or taken for granted. Examples will be presented demonstrating how the sterility assurance SME should partner with various functions in order to effectively address product design, sterilization processing logistics, speed to market, and environmental sustainability.
Meet the Faculty:
Jami McLaren
Vu Le
The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2, has challenged healthcare providers in maintaining the supply of critical personal protective equipment, including single-use respirators and surgical masks. Single-use
respirators and surgical masks can reduce risks from the inhalation of airborne particles and microbial contamination. The recent high-volume demand for single-use respirators and surgical masks has resulted in many healthcare facilities considering
processing to address critical shortages. The dry heat process of 80°C (176°F) for two hours (120 min) has been confirmed to be an appropriate method for single-use respirator and surgical mask processing.
Meet the Faculty:
Scott Weiss
Jeff Nelson
The FDA’s Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance (published in 2015) provided recommendations for how cleaning validations are performed on reusable medical devices. The guidance document identified controls during a cleaning validation. The controls are negative sample control, negative device control, positive sample control, and positive device control. In this presentation, these controls will be defined and explained using examples from cleaning validations. Furthermore, this presentation will explain how to use data from controls for cleaning test method investigations. ;
Meet the Faculty:
Nupur Jain
Shani Haugen
