Important News: MycoScience is now a part of Millstone Medical Outsourcing. Learn more

Services

Contract Manufcaturing

Our expertise with environmental control makes Mycoscience a logical choice for cleanroom contract manufacturing. We specialize in environmentally controlled, low volume, clinical production of diagnostics, pharmaceuticals and devices. We offer a variety of cleanroom options from Class 100 to Class 100,000. Our facilities include a Class 100 syringe filling suite, with the capacity to fill thousands of syringes per hour.

Aseptic Fill

Aseptic fill follows all FDA regulated guidelines for aseptic processes. This means that all parts of the final product are separately sterilized and filled under aseptic conditions such that no terminal sterilization step is required following filling, stoppering, and sealing. Most injectables of small-volume are aseptically processed.

Non-aseptic Fill

Non-aseptic fill does not follow all FDA regulated guidelines for aseptic processes. Thus, a terminal sterilization step will be required after the product is filled, stoppered, and sealed before use in a medical environment.

Contact Us For A Custom Quote

Need help with product development?

We have designed, developed and obtained FDA approval for a wide variety of medical devices and diagnostic products, from HP Fast™ (our rapid test for Heliobacter pylori bacteria) to SPOT™ (our diagnostic marker for colon cancer).

Whatever your requirements, our efficiency and expertise will enable you to achieve timely, cost-effective manufacturing solutions.

  • Research and Development
  • Batching and Filling Services
  • Class 100 – Class 100,000 Manufacturing Areas
  • Prototypes and Clinical Samples
  • Packaging and Sterilization
  • Aseptic Filling of Syringes and Vials
  • Air-Overpressure Steam Sterilization
  • Dedicated Filling Suites

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