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Non-Aseptic Fill Finish Services

Argonaut provides comprehensive non-aseptic fill finish services tailored to meet the diverse needs of diagnostics, medical device and combination product companies. Our expertise spans multiple dosage forms, ensuring flexibility and precision in product formulation and filling. With capabilities in non-aseptic lyophilization, terminal sterilization, and a full QC laboratory, we offer an integrated approach to meet your manufacturing requirements.

Non-Aseptic Fill Finish Services

Argonaut can formulate, fill, test, package, store and distribute your dosage formats.

Our non-aseptic fill finish foundational services include the following:

  • Formulation include complex formulations
    • Filling
    • Lyophilization
  • Packaging
    • Terminal sterilization

Extended GMP manufacturing — from routine to complex solutions:

  • Sourcing of raw materials and components
  • Labeling
  • Device assembly and testing
  • Storage and distribution support
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Quality Control Services

Analytical and microbiological testing service including:

  • Bioburden
  • Endotoxin
  • pH, TOC, conductivity, specific gravity, refractive index
  • Spectropotometry
  • HPLC
  • Client specific method transfer
  • Stability studies

Why Choose Argonaut

Unlike other contract manufacturers, we do not develop or sell our own line of products, 100% of our resources are dedicated to our client’s success.

  • No minimum batch size
  • Engineering builds
  • Manufacturing assessments
  • Flexibility and Scale
  • Integrated, end-to-end solutions

Prioritizing quality from day one, the Argonaut Quality Management System is the overarching structure (link to certificates).

  • ISO 13485:2016
  • cGMP
  • QSR 21 CFR 820, 21 CFR 210, 21 CFR 211
  • FDA registered
  • CA FDB inspected 
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Argonaut Non-Aseptic Fill Finish FAQs

A: We handle a wide array of formats for non-aspetic fill finish including bottles, vials, tubes and custom configurations.
A: There is no minimum size.
A: Yes- this is a core competency as we have our own lyophilization facility.
A: Gamma/ Ebeam/ Ethylene Oxide/Moist Heat/Dry Heat/ and Vaporized Hydrogen Peroxide are offered through our ecosystem.
A: Argonaut has a full in-house QC lab to meet your specifications. We can assess many controls including sterility testing, endotoxin testing, and other safety tests, to ensure product safety and compliance.
A: Yes- we offer full packaging, labeling, storage and distribution services.
A: Absolutely- we offer a turn-key sourcing solution which simplifies supply chain management and reduces lead times.
A: This is largely dependent on the complexity of the project, readiness for manufacturing, and availability of materials. Pilot projects or engineering builds can often be executed in less than three weeks.
A: Argonaut specializes in taking pre-determined formulations and scaling up manufacturing to achieve your required batch size.
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Main Office
2841 Loker Ave E
Carlsbad, CA 92010

Contract Manufacturing Done Right.

Call us at +1 888-834-8892