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Quality processes

Allograft Safety and Sterility: The Power of Allowash XG®

A proven, comprehensive and validated six-step system that combines examination, evaluation, and mechanical, chemical and radiation processes.

Step 1: Control the bioburden
Minimizes incoming microbiological and serological bioburden

  • Rigorous and meticulous donor examination process: less than 2% of all potential donors are accepted.
  • Complete physical examination of the donor.
  • Rigorous retrieval protocols.
Step 2: Evaluation of the bioburden
Evaluation of microbiological contamination

  • All samples recovered from tissues are tested for microbiological contamination.
  • Standard microbiological methods utilizing aerobic and anaerobic media to culture and identify bacteria (and fungi) are used.

Evaluation of serological contamination

  • All blood samples are evaluated for hemodilution.
  • Laboratories must be certified by the CLIA to perform donor examination tests.
  • Test kits must be licensed by the FDA and approved for cadaver testing.
  • The nucleic acid test reduces the “time window” of infectivity.
Step 3: Pollution containment
Clean Room Standards

  • Allografts are processed in state-of-the-art GMP / ISO class 7 rooms or in cleaner rooms.
  • The processing environment is subjected to validated environmental monitoring on a daily, weekly and monthly basis.
  • The centers maintain a level of neatness that minimizes or eliminates the pollution induced by the environment.
Step 4: Cleaning regime
Rigorous cleaning

  • A dry, wet centrifugation sequence designed to expel blood, fat and lipid components from the allograft matrix.
  • Application of patented “Allowash” solution under ultrasonic conditions, designed to remove bacteria and viruses.
Step 5: Disinfection regime
  • It uses a patented step that includes ultrasound, specific temperatures and chemicals to eliminate bacteria and viruses.
  • Followed by several steps of soaking and rinsing, as well as microabsorption to remove possible residual reagents.
Step 6: Complete Sterilization
Low dose gamma radiation is administered under:

  • Controlled conditions including cold temperature.
  • A validated dose mapping configuration.
  • A dose that depends on the allograft.

Results: Allowash XG has been …

VALIDATED

  • Penetrates allograft tissue in depth.
  • Sterilizes allografts to SAL of 10-6
  • t offers effective viral inactivation.
  • It is used for biocompatibility.
  • Maintains the biomechanical or biochemical properties of the allograft.
  • Recognized for its clinical efficacy in several publications.

Allowash XG

Es un proceso de limpieza y esterilización patentado que remueve más del 99% de los elementos medulares y sanguíneos de la matriz ósea interna. Mantiene los bioimplantes de lo injerto estériles sin comprometer las propiedades biomecánicas o bioquímicas necesarias para sus aplicaciones previstas.

Address

 

Av. Tepeyac #816

Col. Chapalita Oriente

Zapopan, Jalisco

México

contacto@bioimplants.mx

✆  (01 33) 20 01 06 44

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