The Centre for Tissue Engineering has been certified to comply with ISO 9001:2000 quality system for the retrieval, processing and supply of allograft tissue for human transplantation. The quality management system of the CTE ensures that its activities are performed according to strict codes of practice and ethics, thereby ensuring that its processes are carefully controlled and audited for compliance.


The CTE ISO 9001:2000 certificate has been issued by SGS United Kingdom Ltd, a certification services company accredited by the United Kingdom Accreditation Services (UKAS) organization.


The most important mission of The Centre for Tissue Engineering in this regard is the adoption of Standards in order to prevent disease transmission and help ensure optimum clinical performance of its products. In its efforts to help maintain tissue engineering and tissue banking at the highest level of quality, the CTE maintains close liaison with the Department of Health of South Africa, ensuring appropriate compliance and control. The Department of Health provides monitoring of various aspects of tissue banking.

The Centre for Tissue Engineering fosters education of students and continuous research to improve quality and safety of its products at its Research and Innovation Unit on the Arcadia Campus of the Tshwane University of Technology

Each donation undergoes the most thorough screening and testing procedures available. This process confirms medical suitability for donation by identifying the donors with disqualifying medical conditions or transmissible diseases such as AIDS, Hepatitis, Syphilis etc.

Tissue is only processed for transplantation if all blood test and other results are 100% satisfactory

Processing and sterilising regimens employed by our suppliers have been proven to destroy the H I Virus ("H I V Inactivation in a Bone Allograft" James T. Melloning et al Journal of Periodontology Dec. 1992) Link to publication information. Even despite this, however, donor selection remains stringent.

 

Donor Selection Criteria:

Any one of the following would immediately disqualify a potential donor:

  • Death or disease of unknown aetiology
  • Disease of central nervous system where cause or origin cannot be established
  • Prion diseases such as CJD / vCJD
  • Septicaemia
  • Hepatitis or early Hepatitis seropostivity
  • Malignancies
  • AIDS or early HIV seropositivity
  • Syphilis
  • Sepsis
  • Auto Immune diseases
  • etc.



 

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