SAVE, CLEAN and EFFICIENT!

CHIPS, SHAPED FEMURAL HEADS AND BLOCKS  

New developments make high demands on safety and quality of human bone allografts and require innovative methods for cleaning and processing.

The European Cell and Tissue Bank (ECTB/ÖGGV) has evaluated modern technologies within cleaning and processing and decided to process chips, shaped femoral heads and blocks in an innovative and considerate way using supercritical CO2. This process allows to meet the increasing demand for ‘clean’ products – above all structural allografts – considering safety and quality requirements. It is a gentle, safe and efficient cleaning process throughout the whole bone matrix even for structural allografts. It is virus-inactivating effect is validated. Lipids and cellular components are removed completely. Collagen and osteoinductive proteins are treated with care. Mechanical properties are mainly unmodified. Thus incorporation in the recipient is faster and more complete.

The resulting product OSTEOpure™ offers ultimate safety and quality, is easy to handle and saves time in the operating room.

ECTB / ÖGGV

The European Cell and Tissue Bank (ECTB/ÖGGV) is a Entnahmeeinrichtung and Gewebebank according to Austrian Tissue Law- Österreichisches Gewebesicherheitsgesetz- which complies  with  a Tissue  Establishment according to EU Directive. ECTB is based in Wels, Austria, and is a non-profit organisation. It´s  main focus is the procurement, storage, processing and distribution of human bone allografts for implantation as well as research and development of new technologies for processing of innovative tissue products for applications in human medicine. The  main objective of ECTB is to supply hospitals with high-quality tissue products meeting the demand of ultimate safety.

INNOVATIVE PROCESSING METHOD FOR INNOVATIVE PRODUCTS

The bone tissue is procured, tested and processed according the EU Directives and Austrian Tissue Law Österreichisches Gewebesicherheitsgesetz.

The essential characteristic of processing is that super- critical CO2 technology is used, currently the most gentle and effective technology of cleaning bone allografts. CO2 is used under a pressure of 250 bar with a temperature of 50°C which puts it into supercritical state. Supercritical means that CO2 has the characteristics of both a gas and a fluid. In this state CO2 has the ability of high penetration throughout the whole bone matrix combined with high potential to solve lipids and cellular components associated with lipids. Using this technology lipids and bone marrow are removed, while the collagen matrix consisting of collagen and minerals is mainly maintained. Osteoinductive proteins are treated with care. The native composition of the matrix promotes osteocunduction. The virus-inactivating effect of the process has been validated several times. By removing fat and cellular components antigens are removed and immunological reactions are avoided.

Because of the unique properties of supercritical CO2 this innovative processing technology enables efficient and gentle cleaning of human bone allografts – also for cortical and structural allografts – and guarantees ultimate biological safety and quality of the products.

The  allografts are  recovered  aseptically from  donors who are selected according to strict criteria including the patient medical record and other exposures or habits to exclude risc factors. they are tested to exclude the presence of viruses and bacteria. the donor screening includes infectious, malignant, neurological, and autoimmune disease and other exposures or habits of the donor that might result in unsatisfactory tissue. The screening is in accordance with the recommendations of the compe- tent authorities, regulatory agencies and associations of tissuebanks. the donor’s serum is screened for the fol- lowing: HIV-1/2-Ab, HTLV-I/II-Ab, HbsAg, HBc-Ab, HCV- Ab, TPPA; utilizing qualified and licensed testing labora- tories. in addition, the screening for hiV and hepatitis is performed with nucleic-acid amplification (NAT, PCR).

The allografts are processed with supercritical COtechnology, dried, double-packaged in blisters or glas vials and sterilized with gamma irradiation of minimum 25 kGy. All processes are performed using qualified technologies, all critical processes are
validated.

The processing laboratory is in possession of the necessary permits and licenses and is GMP-certified. Nation- al and international health inspectors of the competent authorities inspect the laboratory at regular intervals and have issued a permit to process bone tissue, respectively to bring the processed allografts on the market.

INDICATIONS

OSTEOpure TM is used for reconstructions of bone defects and as a filler of bone cysts.

ADVANTAGES

  • The validated virus-inactivation grants ultimate safety.
  • Extraction of lipids and cellular components takes place deep into the bone matrix.
  • The collagen matrix consisting of collagen and minerals is mainly maintained and osteoinductive proteins are treated with care.
  • The native composition of the matrix promotes osteocunduction. (6)
  • The  mechanical  and structural  qualities  are mainly equal to those of unprocessed bone tissue. (8)
  • Using impaction grafting the primary stability of purified allografts is favourable compared to not purified, fatty transplants. (2, 3)
  • The cleaning process uses only non-toxic solvents.
  • Processed chips, femoral heads and blocks have no immune response of the recipient.
  • Incorporation at the recipient therefore takes place faster and more complete. (1, 6, 9)
  • The allografts are double-packaged in blisters or glas vials and sterilized.
  • Storage takes place under room temperature conditions for up to 5 years.
  • The  products  are easy  to  handle and  user-friendly shapening saves time in the operating room.