Quality and safety

Biomaterial manufacturing processes are subject to quality management system and Geistlich Pharma is certified according to ISO9001 and ISO13485 international standards.

Bone substitute devices

Geistlich Pharma produces Geistlich Bio-Oss® and Geistlich Bio-Oss® Collagen bone substitute devices.

Safety

Processes fulfil stringent safety requirements:

  • Australian (and for some countries New Zealand) bovine material used exclusively; Australia and New Zealand are historically free of bovine spongiform encephalopathy (BSE) and are being ranked as countries with negligible BSE risk1.
  • Bone is sourced from selected and certified abattoirs and suppliers and animals with certified fitness for human consumption.
  • Extremity bone is the only used bovine tissue at Geistlich Pharma - a tissue with no detected BSE infectivity2.
  • The collagen part of Geistlich Bio-Oss® Collagen is derived exclusively from Swiss porcine tissue.

Chemical and physical purification process

  • Stringent and validated process standards result in a highly purified bone mineral substance of consistent quality.
  • Manufacturing process consists of several consecutive steps combining different modes of action with high inactivating capacity against potential infective agents.
  • Evaluated to reliably inactivate viruses and bacteria.
  • Evaluated by experts as highly effective against prions. The risk of BSE agents transmission can be regarded as negligibly low.
  • The applied risk reducing measures were certified by the European Directorate for the Quality of Medicines and Healthcare (EDQM) as fully compliant with the European Pharmacopoeia monograph 5.2.8 ‘Minimising the risk of transmitting TSE agents via medicinal products’ and the monograph no. 1483 on ‘Products with risk of transmitting TSE agents’ (Certificate of Suitability No. R1-CEP 2004-122-Rev 01) (TSE: transmissible spongiform encephalopathy).

Sterilisation

  • Products are sterilised by gamma irradiation.
  • Geistlich Bio-Oss® and Geistlich Bio-Oss® Collagen are provided sterile in double-layer packaging.

Allergic reaction

  • Allergic reactions are highly unlikely because Geistlich Bio-Oss®  does not contain organic components.
  • Geistlich Bio-Oss® Collagen contains collagen; allergic reactions and inflammatory tissue reactions may occur in rare cases. The product should not be used in patients with known allergy towards collagen.

Verena.jpg
Verena Vermeulen
Scientific Communication Manager