Sensitive Materials

Particularly with sensitive materials, SteriTek has developed a proprietary system for optimizing E-beam/X-ray sterilization of drugs/biologics, allograft/xenograft tissue product, combination devices and other complex products.

SteriTek offers medical device, biotech and pharmaceutical companies with expertise in optimizing E-beam/X-ray for complex devices and sensitive materials (combination devices, drugs, biologics, allograft tissue)

 

  • Approved by DEA for Schedule II through V substances
  • In conjunction with Sustained Nano Systems, SNS Densomere™ Technology- The Next Generation of Sustained Drug Delivery and Biologic Terminal Sterilization, optimizing E-beam/X-ray for most molecules, including biologics, biosuperiors, antibodies, and other macromolecules
  • Continuous Temperature Control in with Walk-in Refrigerators (2 to 8C), Freezers (-16 to -26 C) and proprietary Cryotote system to keep product frozen (-60 to -80C) during processing
  • Split Dose Processing
  • Intelligent Tooling and other advanced methods

Drugs/Pharmaceuticals

  • Lyophilized Powders
  • Solutions
  • Solids
  • Pre-filled Syringes
  • Microspheres
  • Nanoparticles
  • Implantables
  • Bioresorbables

 

Tissue/Biologics

  • Allograft/Xenograft
  • Orthobiologics
  • Sports Medicine
  • Regenerative Medicine
  • Wound Care/Closure Systems

With its advantages over almost all other current sterilization techniques, X-ray sterilization is the up and coming sterilization technique and warrants your consideration both for new products and for transition of current products. Already included in international standards and FDA guidelines, the usage of X-ray sterilization is already approved by regulatory bodies. The current, biggest challenge, as with any new technology, is finding facilities that offer this service. This should not be a problem in the years to come.