Terminal Sterilization Services

Argonaut provides comprehensive terminal sterilization 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 lyophilization, terminal sterilization, and a full QC laboratory, we offer an integrated approach to meet your manufacturing requirements.

Are you looking for Sterile Fill Finish? See our Aseptic Fill Finish Services page.

Terminal Sterilization Services

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

Our terminal sterilization foundational services include the following:

  • Formulations, including complex formulations
  • Packaging
    • Terminal sterilization
Argonaut Manufacturing Services 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
Learn more about our available services...
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Quality Control Services

Analytical and microbiological testing service including:

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

Learn more on the Analytical and QC Services page 

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 
Know what to expect & when...
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Resources to help you choose a contract Manufacturer

Whether you are just starting to consider if a contract manufacturer is right for you, or are an experienced operations professional looking to hone your outsourcing game, Argonaut’s free resources can help guide the way.

Latest Guides:

Non-Sterile Fill Finish Services – How to Evaluate a Contract Manufacturing Organization

non-sterile fill finish - Argonaut Manufacturing Services
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Deciding to engage a contract manufacturing organization (CMO) for your non-sterile fill finish needs can bring a number of rewards, including manufacturing flexibility, reduced capital expenditures, speed to market, and scalability. Importantly, you . . .

Argonaut Terminal Sterilization 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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