Our Sterilization Skillsets
At NEUMA, we know the struggle of identifying and resolving the constraints of sterilization for new devices already balancing manifold requirements. We use our experiences of common sterilization methods coupled with an analytical approach to develop robust sterilization processes. Whether the product and process are at conceptualization, engineering development, validation, or established in the market, we can develop and implement solutions to improve quality, efficacy, and/or cost.
For most medical products, achieving sterility is among the highest development priorities. Consequently, it should be natural to give this process serious attention and effort in the development cycle. Unfortunately, many project teams fall into one extreme or another: either ignoring challenges until confronted with failed tests late in development, or adopting conservative, rigid guidelines that increase cost and lead times while limiting innovation. However, more deliberate, proactive efforts generally reduce development costs and decrease time to market.
Device sterilization capability assessment Product-specific sterilization method comparison & selection Material selection Functional impact test: planning & execution Primary and secondary packaging design Container Closure Integrity: Overall sterile barrier system definition through to test method selection & development Validation planning Root cause analysis (microbiological, chemical, & mechanical)Explore More
Develop sterilization processes for: All FDA Established Category A methods (dry heat, EO, steam, irradiation) Several FDA Established Category B methods Novel methods, if applicableExplore More
Sterilization process analyses, including Dose uniformity calculations for all radiation sterilization processes Gas diffusion & heat transfer analyses Optimized exposure determinations for bioburden methodologies Most Resistant Site determinationExplore More
Meet our Sterilization Engineering Experts
DIRECTOR, NEUMA ENGINEERING
Markets That Benefit from Our Sterilization Engineering Solutions
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics & Cell and Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.
Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.
The NEUMA Sterilization Engineering Difference
NEUMA offers a forward-thinking approach to the product development lifecycle, accessing both industry-leading technologies and disruptive innovations to position products for commercial success.
Our team applies Kymanox’s development toolkit of project management, development, and quality management tools that can be customized to the needs of your company and project to ensure efficient and “fit for purpose” solutions to meet your project objectives.
Our team's broad experience and integrated development approach ensure the Right First Time products for unmet patient needs in accordance with US FDA, EU EMA, and rest-of-world regulatory requirements.
We offer unmatched experience and knowledge across pharmaceuticals, biologics, medical devices, combination products, and "in vitro" diagnostics, so we are equipped to tackle any project in these areas. Our Development leads serve as a central hub to leverage subject matter experts from across the organization.
Read the Latest at Kymanox
Kymanox Acquires Agilis Consulting Group, A Trusted Human Factors Provider
Kymanox Acquires Agilis Consulting Group, A Trusted Human Factors Provider Integrating the well-respected and trusted Agilis brand and team extends Kymanox’s capabilities in human factors (HF) by adding incredible talent, the ability to conduct HF stu...
Investment Reports Interview with Stephen M. Perry, CEO and Founder of Kymanox
Kymanox CEO and Founder, Stephen M. Perry was interviewed as part of the Investment Reports article, The New Era of Life Sciences 2023, published on 17MAR23, What were the circumstances that brought Kymanox to life and what does your present foo...
Kymanox Acquires EU Based Anteris Medical and Anteris Helvetia
Leveraging the well-respected anteris brand and team, this acquisition extends Kymanox’s capabilities and geographic reach with a strong European presence Friday, 03 February 2023 Morrisville, North Carolina, USA and Holzkirchen, Germany an...