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.
Sterilization Engineering
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.
01
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)
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02
Develop sterilization processes for:
All FDA Established Category A methods (dry heat, EO, steam, irradiation)
Several FDA Established Category B methods
Novel methods, if applicable
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03
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 determination
Explore More Meet our Sterilization Engineering Experts
Shaun Devitt
DIRECTOR, NEUMA ENGINEERING
Markets That Benefit from Our Sterilization Engineering Solutions
Combination Products
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.
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.
Comprehensive Solutions
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.
Turnkey Support
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.
Unmatched Expertise
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.
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