Quality and safety
To consistently provide safe and high quality products, Geistlich Pharma strictly manages the entire production chain including the selection and control of the raw material, research and development, as well as production and storage. In this way, we can assure all steps are conducted in accordance with our quality management system. Geistlich Pharma is certified according to ISO9001 and ISO13485 international standards. We consistently meet or exceed industry safety and quality standards and follow a continuous training program for our employees. These substantial efforts lead to a single goal – to provide the highest standard of product quality and safety in order to improve the patients’ quality of life.
Bone substitute devices
Geistlich Pharma produces Geistlich Bio-Oss® and Geistlich Bio-Oss Collagen® bone substitute devices.
Safety
Processes fulfill stringent safety requirements:
- Australian bovine material used exclusively; Australia is historically free of bovine spongiform encephalopathy (BSE) and is ranked as a country with negligible BSE risk1.
- Bone is sourced from selected and certified abattoirs, suppliers and animals with certified fitness for human consumption.
- Extremity bone is the only bovine tissue used at Geistlich Pharma - a tissue with no detected BSE infectivity2.
- The collagen portion 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 ‘Minimizing 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).
Sterilization
- Products are sterilized 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 as 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 to collagen.
Collagen membranes and matrices
Geistlich Pharma produces the porcine collagen-based materials Geistlich Bio-Gide®, Geistlich Bio-Gide® Perio, Geistlich Mucograft® and Geistlich Mucograft® Seal.
Safety
Geistlich Bio-Gide®, Geistlich Bio-Gide® Perio, Geistlich Mucograft® and Geistlich Mucograft® Seal fulfill strict safety requirements.
- Produced exclusively from Swiss porcine tissue.
- Processing of collagen for medical use is subject to strict safety regulations.
Chemical purification process
- Fat and other unwanted tissue components are removed.
- Potential micro-organisms are inactivated.
- The process results in a highly purified collagen structure.
Sterilization
- Products are sterilized by gamma irradiation.
- Geistlich Bio-Gide®, Geistlich Bio-Gide® Perio, Geistlich Mucograft® and Geistlich Mucograft® Seal are provided sterile in double-layer packaging.
Allergic reaction
- Geistlich Bio-Gide®, Geistlich Bio-Gide® Perio, Geistlich Mucograft® and Geistlich Mucograft® Seal contain collagen; allergic reactions and inflammatory tissue reactions may occur in rare cases. Products should not be used in patients with known allergy to collagen.
CAUTION: Federal law restricts these devices to sale by or on the order of a dentist or physician.
