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Capabilities | Advanced Manufacturing | Clean Room Manufacturing

End-to-end manufacturing in controlled environments

From prototype to production, complex medical and life sciences products need the right infrastructure and expertise in order to maintain sterility, precision, and reliability. Ascential™ delivers bespoke clean room manufacturing solutions designed to help you meet the highest standards of quality and FDA/ISO compliance and scale globally.

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Services

Full-service clean room manufacturing

Get integrated support across design, development, and manufacturing of complete systems and subsystems. Whether you’re building a Class II device or a new diagnostic instrument, our clean room infrastructure ensures your product meets critical requirements.

Clean Room
Manufacturing

Manufacture in certified environments for medical, life sciences, and biotech applications, including ISO 8 certified and NAI classified facilities.

Turnkey Manufacturing

Access manufacturing components and expertise attuned to your product specifications — from pilot builds to full-scale production and packaging.

Automated & Manual Processes

Whether you’re executing high-volume or precision low-volume builds, Ascential offers automated and manual processes.

Microfluidics, Optics, and Motion Systems

Build precision manufacturing for complex subsystems in our cross-functional clean room infrastructure.

GMP-Compliant Production

Ensure alignment with FDA, ISO 13485, and other global regulatory standards.

Capabilities

Scalable designs for regulated environments

With both domestic and international clean room capabilities, we offer flexible solutions tailored to your product’s application, regulatory needs, and go-to-market strategy.

Whether you need regional support or global scalability, our teams help you build the right manufacturing strategy for success. Ascential supports a wide range of applications, including:

  • Implantable and complex medical devices
  • Point-of-care and lab diagnostics
  • Complex electromechanical assemblies requiring particulate control
  • Consumables and implantables
  • Potent compounds
Learn More about Our Quality Standards & Facility Capabilities
Compliance & Regulatory Status

Certified clean room manufacturing

Our Ham Lake site is FDA-registered and, most recently, received an NAI inspection classification confirming that no objectionable conditions or practices were found. We operate under ISO 13485:2016 and hold Minnesota state licensing for medical device manufacturing.

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FDA Registered Facility
Manufacturing establishment registered with the FDA.
Most Recent FDA Inspection
Classification: NAI No Action Indicated.
ISO 13485:2016
Quality management system for medical devices.
Minnesota Licensed
Licensed for medical device manufacturing in MN.

Note: FDA site inspections do not result in a traditional “certification.” They determine compliance and classify outcomes. Most recent result: NAI.

Assembly, testing, packaging
Prototype to scaled production
ISO Class 8 clean rooms
Independent environmental controls

Why Choose Ascential?

Ascential’s distinct clean room manufacturing expertise, capacity, and capabilities enable our teams to provide comprehensive, bespoke solutions to our clients’ regulated product development.

Proven Expertise

A partner with 70+ years of experience delivering regulated medical manufacturing solutions, bridging engineering and compliance knowledge from 8 highly specialized firms.

Fully Integrated Capabilities

Preserve production speed and performance with collaborative support across engineering, advanced automation, and production teams.

Global
Footprint

Tap into a network of FDA/ISO-certified facilities for localized support and global manufacturing capabilities.

Commitment to Quality & Compliance

Meet the highest standards of performance and regulatory compliance to support your high-risk application.

Frequently Asked Questions

Get answers to common questions about our clean room manufacturing capabilities.

We specialize in medical and life science devices, from complex diagnostics to therapeutic systems. Whether you’re developing a new high-stakes diagnostic instrument or refining an existing one, Ascential brings deep technical, design, and engineering expertise to ensure manufacturability and product success. We can accommodate smaller volume production and larger commercialization plans for the following applications, among others:

  • Implantable and complex medical devices
  • Point-of-care and lab diagnostics
  • Complex electromechanical assemblies requiring particulate control
  • Consumables and implantables
  • Potent compounds
Involve our team as early as possible during concept development. Our workshops utilize our proven Manufacturing Development Pathway to uncover risks, align teams, and build a step-by-step commercialization plan tailored to your unique product needs.
Absolutely. With a global network of FDA/ISO-certified facilities, we help clients design, build, and launch products in full compliance. Our teams have a clear understanding of clean room manufacturing requirements both internationally and domestically, with the certified environments and bandwidth to support your production cycle.
Our cross-functional teams collaborate early to design for manufacturability as well as clean room compatibility and compliance. This ensures a smoother transition from prototype to production and enables a more timeline-driven, cost-efficient scale-up.

Related Resources

Trust credentialed clean room manufacturing experts

Learn how Ascential can bring your most sensitive, high-risk products to market in full compliance and confidence.

Speak with an Expert

Get Your 15-Minute Consultation