NovaSterilis

NovaSterilis NovaSterilis uses supercritical CO2 solutions to promote safe, innovative products and improve lives.

NovaSterilis is the global leader in the development and manufacturing of supercritical carbon dioxide (scCO2) processes for biomaterials and medical devices, including the decellularization and sterilization of allograft and xenograft tissues. At its core, NovaSterilis is a team of scientists, engineers, and business people committed to meeting our customers' needs through problem-solving. Our multi-disciplinary team of engineers, biochemists, and molecular and cellular biologists bring their broad and deep knowledge to every development challenge. We have the team, equipment, and processes readily available to provide scCO2 solutions that enable the implementation of manufacturing solutions that meet product safety requirements and performance and enable our partners to deliver safe, innovative products that advance patient healing and outcomes. With NovaSterilis you can count on a sterility assurance level 10-6, an environmentally friendly solution, shorter turnaround times, and more. Protect and differentiate your products with supercritical CO2.

Effective   depends on aligning SAL requirements with material constraints through approaches such as overkill, bioburde...
12/15/2025

Effective depends on aligning SAL requirements with material constraints

through approaches such as overkill, bioburden, and combined BI/bioburden methods.

Discover how each validation strategy functions, where it applies,

and how to evaluate compatibility challenges: https://bit.ly/3TQ8QD0

  is a low-temperature process that penetrates intricate microstructures, supports materials in different states (lyophi...
12/12/2025

is a low-temperature process that penetrates intricate microstructures, supports materials in different states (lyophilized, hydrated, liquids, etc.), and preserves sensitive natural and synthetic polymers for regenerative and 3D-printed applications. Explore how fits into additive manufacturing: https://bit.ly/3XwioEz

12/11/2025

Biologics manufacturing continues to be constrained by methods that compromise protein structure and bioactivity. Explore why the industry is reconsidering long-standing assumptions about what “compatible” sterilization really means and dive into as a solution: https://bit.ly/4cypoa1

12/10/2025

This side-by-side visualization that compares material behavior under two depressurization conditions (purge vs. no purge) reveals how process variables directly influence compatibility for elastomeric materials. These observations provide critical insight for process optimization and material-safe using scCO2.

Watch more videos about the inside of the process: https://bit.ly/4qZsI4H

  directly influences manufacturability, cost structure, regulatory timelines, and even product performance. Discover wh...
12/09/2025

directly influences manufacturability, cost structure, regulatory timelines, and even product performance. Discover why integrating planning into early R&D is beneficial for product evaluation: https://bit.ly/3rZMCm1

When medical devices and biomaterials push new limits,   alternatives often are next. We’ve compiled a technical overvie...
12/08/2025

When medical devices and biomaterials push new limits, alternatives often are next. We’ve compiled a technical overview of supercritical CO2 ( ). Download the scCO2 Sterilization Guide to explore compatibility, validation pathways, and R&D applications: https://bit.ly/40xnmCp

Traditional   methods can compromise structural and biological integrity of complex implantable devices and biomaterial-...
12/05/2025

Traditional methods can compromise structural and biological integrity of complex implantable devices and biomaterial-based technologies. This study highlights how conventional heat, radiation, and chemical approaches fall short when applied to sensitive materials, while shows consistent viability. Read it here: https://bit.ly/3sl3yE7

12/04/2025

Real-time observation of material response during pressurization, dwell, and depressurization reveals how porous and complex structures actually interact with . These insights can help inform material design, process development, and post-processing strategies for research. Learn more: https://bit.ly/3KkJnz8

Most companies select    conditions that are more aggressive than necessary, limiting flexibility for devices produced i...
12/03/2025

Most companies select conditions that are more aggressive than necessary, limiting flexibility for devices produced in controlled environments with well-characterized bioburden. Overkill, bioburden-based, and combined validation strategies offer different regulatory and material tradeoffs. Explore these validation pathways and where fits:

Strong Bioburden control processes give device manufacturers more flexibility when choosing sterilization validation strategies. Read more.

Many novel, temperature-sensitive, and complex products remain difficult to sterilize without compromising structure or ...
12/02/2025

Many novel, temperature-sensitive, and complex products remain difficult to sterilize without compromising structure or function. A supercritical fluid process that combines gas-like diffusivity with liquid-like solvency enables deep, uniform pe*******on while maintaining material integrity. Learn more about the science and application of : https://bit.ly/42XG58u

Many tissue banks are actively assessing e-beam for   and comparing a move to  ,. Take a quick read of this comparison f...
12/01/2025

Many tissue banks are actively assessing e-beam for and comparing a move to ,. Take a quick read of this comparison for two sterilization modalities for tissue banks:

Compare in-house supercritical CO₂ vs contract e-beam sterilization with peer-reviewed data and cost analysis insights. Explore the insights.

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3109 North Triphammer Terrace
Lansing, NY
14882

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