Please ensure Javascript is enabled for purposes of website accessibility
SEARCH Contact

Capabilities | Advanced Manufacturing | Aseptic Manufacturing

Sterile product manufacturing, from the first to last steps

Ascential delivers reliable, large-scale production of sterile, high-quality life science instruments and consumables through its aseptic manufacturing processes. Designed to help you meet the highest standards of quality and FDA/ISO compliance and scale globally so you can confidently transition from product development to commercial production.

Speak with an Expert

Get Your 15-Minute Consultation

Services

Sterile quality and controlled production at scale

Aseptic manufacturing is embedded into Ascential’s manufacturing and quality processes, where sterility, contamination control, and regulatory requirements are evaluated at every major step. Our ISO-Class 8 cleanrooms and expert teams design and execute controlled workflows that minimize risk while maintaining consistent output as production volumes increase. This disciplined approach ensures that sterile products are built, assembled, and packaged in environments that support long-term performance and patient safety.

Cleanroom Manufacturing & Assembly

Maintaining cleanrooms is challenging. Ascential's aseptic manufacturing services provide compliant assembly, integration, and packaging to ensure the stability of your environments.

Environmental Monitoring & Control

Particulate and microbial monitoring that supports and controls ongoing aseptic compliance. Ascential works directly with your team to efficiently monitor your lab or facility.

Sterilization Strategy & Validation

Offering a strategy that keeps products sterile sets teams up for success. Ascential defines and supports validated sterilization methods that protect product performance.

Pilot Builds & Scale-Up

Testing before launch is crucial to a production line’s advancement. Bolstering the transition from early builds to commercial volumes without compromising sterility is a nonnegotiable piece of aseptic manufacturing.

Capabilities

Aseptic manufacturing expertise

Reduce risk, achieve regulatory readiness, and move toward commercial production with confidence. Our engineers and manufacturing specialists apply validated methods throughout the production lifecycle to support consistent quality, controlled environments, and predictable scale-up for regulated products.

Contamination Control

Processes are designed to reduce microbial and particulate risk through controlled environments, disciplined operator practices, and validated workflows.

Process Repeatability

Methods ensure batch-to-batch consistency for sterile products. We execute IQ, OQ, and PQ, generating audit-ready documentation and SOPs to prove process control and regulatory readiness.

Regulatory Readiness

Documentation, validation, and quality integration support compliance with applicable regulatory and customer requirements.

Why Choose Ascential?

From producing life science instruments to consumables to sterile assemblies, Ascential brings the infrastructure, expertise, and discipline required for safe, compliant products.

Proven Expertise

A partner with 70+ years of experience in delivering mission-critical solutions, bridging engineering, automation, and manufacturing knowledge from 7 highly specialized firms.

Global Presence

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

Solution-Oriented Approach

Find flexible, scalable automation solutions for your unique application. Address process and product challenges at every juncture.

Commitment to Quality

Preserve production speed and meet the highest standards of performance and regulatory compliance.

Frequently Asked Questions

Get answers to common questions about our aseptic manufacturing capabilities.

The earlier aseptic considerations are integrated, the greater the impact. Engaging Ascential during development or early pilot builds helps identify contamination risks, infrastructure gaps, and regulatory requirements before they delay timelines or compromise product integrity.
Customers often struggle with building and validating compliant aseptic processes, controlling contamination risk, and scaling from pilot builds to repeatable production. Gaps in cleanroom infrastructure, documentation, and regulatory readiness frequently increase both risk and time to market.
Customers can expect validated, repeatable aseptic processes that deliver consistent product quality and support commercial-scale production. The result is reduced risk, faster time to market, and confidence that sterile products perform as intended for patients and end users.
Yes. Ascential supports sterile manufacturing from early pilot builds through full commercial volumes while maintaining aseptic control, documentation rigor, and quality alignment at every stage.
Our teams execute IQ/OQ/PQ validation, environmental monitoring, batch record management, and quality system integration to ensure manufacturing operations meet applicable regulatory and customer requirements.

Related Resources

Maximize product integrity and patient safety with aseptic manufacturing

Learn how Ascential’s aseptic manufacturing capabilities help reduce contamination risk, support regulatory compliance, and enable reliable scale-up of sterile products.
Talk to an Expert

Get Your 15-Minute Consultation