NovaSterilis

03/16/2026

Supercritical CO2 sterilization is an effective modality for single-use and reusable medical devices.

This study demonstrates that scCO2 and peracetic acid (PAA) is an effective terminal sterilization modality against resistant bacteria strains.

Explore the findings on additive-assisted lethality: https://bit.ly/40fniXh

03/13/2026

confirms that defined process parameters achieve the required sterility assurance level.

Selecting between overkill, bioburden, and combined BI/bioburden strategies requires balancing microbial control and material sensitivity.

Explore these validation approaches and regulatory considerations: https://bit.ly/3TQ8QD0

03/12/2026

Our Guide has been updated with several new additions!

The latest updates expand compatibility data for materials exposed to sterilization.

Download your updated copy here: https://bit.ly/3pueZIn

03/09/2026

Interest in low-bioburden powder APIs is rising, highlighting opportunities for processing.

Currently, these powders require precise microbial control and careful formulation before .

However, scCO2 can be a suitable terminal sterilization method for a variety of APIs, which can significantly reduce the amount of effort required during the production process.

This article dives into the growing trend in and development. Read more:

Explore how low bioburden powders for terminal sterilization support sterile drug development, improve contamination control, and enable reliable terminal sterilization strategies for complex biopharma products.

03/05/2026

achieves a sterility assurance level of 10-6 across critical microorganisms.

It effectively inactivates bacterial spores, viruses, yeast, and molds.

This technology provides reliable, broad-spectrum while maintaining product integrity.

03/04/2026

face increasing demands for terminal sterility without compromising graft performance.

Radiation and antibiotic washes introduce trade-offs in collagen integrity and contamination risk.

Meanwhile, achieves SAL 10-6 while preserving structural and biochemical properties.

Dive into the accelerating adoption of supercritical CO2:

Learn how supercritical CO₂ sterilization delivers terminal sterility while preserving tissue graft integrity to meet clinician demands.

03/03/2026

Our VP-1000 equipment provides unprecedented insight into the process.

Seeing inside the vessel reveals fluid dynamics, material interactions, and process behavior.

Learn more about our new visualization capabilities: https://bit.ly/4qZsI4H

02/27/2026

Contamination-driven experiment loss can increase cost and delay R&D timelines.

testing verifies your material integrity and functional performance post-sterilization.

It identifies packaging, parameter, and scalability constraints before capital investment. https://bit.ly/4kjEnIt

02/25/2026

Detergent-based compromises ECM structure and bioactive signaling.

This study evaluates a detergent-free scCO2-EtOH approach for heart dECM processing.

Findings showed that the method preserved structural proteins and key angiogenic factors.

Read more about for regenerative therapies: https://bit.ly/3GZuL6X

02/23/2026

EtO emissions constraints are reshaping strategies and validation planning.

Tony Eisenhut, CEO of NovaSterilis, evaluates performance and scalability as an alternative.

Explore adoption barriers and infrastructure requirements for scCO2: https://bit.ly/3p7NnIS

02/19/2026

Sterilization validation involves multiple pathways, data requirements, and regulatory decision points.

Gaps in planning often surface late, increasing risk to timelines and submissions.

This checklist consolidates key elements needed for a defensible validation strategy. Download your copy: https://bit.ly/45f6wrW

02/18/2026

High-intensity sterilization can damage devices produced under controlled, low-bioburden conditions.

Overkill, bioburden, or the combined sterilization validation method can be leveraged to preserve device performance while still meeting SAL requirements.

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