Sterility Assurance Level is typically an afterthought but can significantly impact product development schedules. Integrating sterilization strategies early on is vital for ensuring successful and timely introductions. In this article, Tony Eisenhut, CEO of NovaSterilis emphasizes the importance of considering sterilization in the early stages of R&D for new medical devices or therapeutics. Exploring Alternatives for Effective
Ethylene oxide sterilization is a broadly used method within the industrial and healthcare industries for sterilizing a wide range of products. But its potential environmental and health effects have raised concerns among advocacy groups and government agencies. In this article, Tony Eisenhut, CEO of NovaSterilis, stresses the importance of finding better alternatives to EtO sterilization.
Supercritical CO2 (scCO2) sterilization is a safe and highly efficient method for sterilization with many applications in the MedTech industry. While ethylene oxide (EtO) has long been the leading industrial sterilization modality, its emissions have raised concerns regarding its impact on human health and the environment. In this context, scCO2 has emerged as a promising
November 25, 2019 The FDA chooses NovaSterilis to work directly with the FDA on new approaches to medical device sterilization focused on identifying alternatives to ethylene oxide (EtO) sterilization methods. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies
February 2, 2020 NovaSterilis technical team co-authors paper published in Biochimica et Biophysica Acta (BBA) – Proteins and Proteomics titled “Sterilization of epidermal growth factor with supercritical carbon dioxide and peracetic acid; analysis of changes at the amino acid and protein level” https://www.sciencedirect.com/science/article/abs/pii/S1570963919302195
February 18, 2020 NovaSterilis places NovaGenesis benchtop supercritical CO2 system at Universidade de Santiago de Compostela prior to the university hosting “EIFS 2020, the First Iberian Meeting on Supercritical Fluids” https://flucomp.es/eventos/eifs2020
August 1, 2020 Surfaces in Biomaterials Foundation Summer 2020 newsletter chronicles NovaSterilis’ and iFyber’s rapid mobilization of resources to address demands for reprocessing of PPE in support healthcare providers through COVID-19 pandemic. https://www.surfaces.org/resources/Documents/SurFACTS/2020/SurFACTS%20Summer%202020.pdf
August 21, 2020 The FDA issued an emergency use authorization (EUA) to NovaSterilis, Inc. for its Nova2200, which uses the NovaClean decontamination process. Nova2200 can be used to decontaminate compatible N95 respirators for single-user reuse by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) during
February 9, 2021 NovaSterilis will present at the Advanced Regenerative Manufacturing Institute’s workshop on March 11, 2021. The workshop topic is Scaffold Fabrication Tools and Equipment. Tony Eisenhut, CEO of NovaSterilis, will present Supercritical Carbon Dioxide: A Terminal Sterilization Solution for Bio-based Materials. Register for the event at https://www.armiusa.org/events/2021/2/11/a-template-for-the-future-of-biomanufacturing-virtual-workshop-series-zh2np
February 13, 2021 NovaSterilis working with medical device manufacturers and regulators to reduce EO emissions. https://www.packagingdigest.com/medical-packaging/medical-device-makers-see-progress-eo-sterilization
December 21, 2021 NovaSterilis and iFyber researchers collaborate with Universidade Catolica Portuguesa and Universidade Nova de Lisboa on a technology review publication that identifies contributions of supercritical fluid technology for decellularization of biological materials. https://doi.org/10.1039/D1MH01720A
October 1, 2019 Advanced Regenerative Medicine Institute (ARMI) features NovaSterilis in its new member spotlight. https://www.armiusa.org/news/2019/10/1/new-member-spotlight-novasterilis
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