Capabilities - Engineering
Clean Room Manufacturing
End-to-End Manufacturing in Controlled Environments
Ascential Medical & Life Sciences delivers scalable manufacturing in clean room environments designed to meet the highest standards of quality and regulatory compliance. From prototype to production, we support complex medical and life sciences products with the infrastructure and expertise needed to maintain sterility, precision, and reliability throughout the manufacturing process.
Our workshops utilize our proven Manufacturing Development Pathway to uncover risks, align teams, and build a step-by-step commercialization plan.
Impossible? Done.
Full-Service Clean Room Manufacturing
Our clean room capabilities include integrated design, development, and manufacturing of complete systems and subsystems. Whether you're scaling a Class II medical device or launching a new diagnostic instrument, our clean room infrastructure ensures your product meets critical requirements.
Our capabilities include:
Clean Room
Manufacturing
Certified environments for medical, life sciences, and biotech applications including ISO 8 certified facilities.
Turnkey
Manufacturing
From pilot builds to full-scale production and packaging.
Automated and
Manual Processes
Supporting both high-volume and precision low-volume builds.
Microfluidics, Optics, and Motion Systems
Precision manufacturing for complex subsystems.
GMP-Compliant
Production
Alignment with FDA, ISO 13485, and other global regulatory standards.
Our
Facilities
Learn more about our certifications and facility capabilities.
Scalable Designs for Regulated Environments
Our cross-functional teams collaborate early to design for manufacturability and clean room compatibility. This ensures a smoother transition from prototype to production and enables more efficient scale-up.
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, we help you build the right manufacturing strategy to meet your goals. Learn more about our global footprint.
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
Why Ascential?
Decades of
Experience
In regulated medical manufacturing.
Fully Integrated Capabilities
Across engineering, automation, and production.
Global
Footprint
With localized support and scalable capacity.
Quality &
Compliance
Standards to support high-risk applications.
Partner with Us
Partner with Ascential to bring your most sensitive products to market with confidence.
Contact us today to learn how we can support your next project.