Manufacturing

ISO 13485:2016 and GMP certified facility

The products at AXIO are manufactured in our ISO 13485:2016 certified facility owned and operated by AXIO.

  • State of the art manufacturing facility is located in Pharma tech park at City of Ahmedabad, Gujarat, India.
  • Custom built imported machinery with 75-80% automated processing. Minimal human intervention reducing handling errors.
  • 5000sq.ft cleanroom area built according to cGMP, FDA guidelines under Class 10000 manufacturing area.
  • Gamma sterilization done terminally. Full traceability from finished product to raw material source.
  • All 3rd party vendors audited and qualified by EU notifying body.
We at Axio benchmark ourselves to global standards and follow appropriate regulatory guidlines in respective countries of operations. We follow a process that is based on a strong foundation of manufacturing quality standards, mutually beneficial relations with our customers, dealers and all professionals associated with us.

Axio ensures and complies with environmental policies for manufacturing facility of medical devices. No hazardous, polluting effluents are discharged into the environment. Proper handling and disposal of industrial waste is in compliance with local law.

Manufacturing capacity: 1 million+ units per year.

See Our Certifications
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The key differentiators of Axio chitosan technology

A.C.T

A. Product Innovation

Axio’s current product has strong proprietary technology that enhances the haemostatic properties of its biopolymer – 100% chitosan:

  • Enhances absorption leading to concentration of erythrocytes and platelets leading to Platelet adhesion, aggregation and coagulation resulting in enhanced clotting.
  • Enhances basic mucoadhesive and polycationic properties of the product that enhances adhesive effect.

B. Process & manufacturing innovation

Axio has process and manufacturing innovation that substantially enhances the product and delivers. Right concentration of the Active Ingredient in the right form factor for trauma wounds.
Strong Process that is based on bio-engineered chitosan ensures –

  • 100% chitosan dressing with Low polydispersity index provides good hemostatic and bacteriostatic properties.
  • Ensures that the chitosan dressing which is active on all sides, provides higher surface area per unit mass for quicker blood absorption and hemostasis effect.
  • Manufacture through natural cross-linking throughout the process without the use of any chemical cross-linking agents.
  • A pH controlled end product, which helps in easy removal of the product from the wound using water or saline.

C. Advantages over Competition

  • Better water and blood absorbency & adhesion.
  • Quicker hemostasis than zeolite/kaolin-based silver impregnated dressings due to inherent cationic charge of reengineered chitosan.
  • Quicker hemostasis than chitosan impregnated gauze due to higher porosity, blood absorbency and adhesion.
  • 100% natural chitosan obtained from purer sources compared to other chitosan from exoskeletons that competition use.
  • Easy, Quick removal without causing further trauma to the wound and doesn’t leave any residue behind.