Quality and safety

Biomaterial manufacturing processes are subject to quality management system and Geistlich Pharma is certified according to ISO 9001 and ISO 13485 international standards.

Porcine 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. Geistlich products are subject to validated manufacturing and strict quality assurance standards.

Safety

Geistlich Bio-Gide®, Geistlich Bio-Gide® Perio, Geistlich Mucograft® and Geistlich Mucograft® Seal fulfil 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 in an intensive multi-stage purification process.
  • Potential micro-organisms are inactivated.
  • The process results in a highly purified collagen structure.
  • Regular inspection of production processes by independent institutions and government authorities.


Sterilisation

  • Products are sterilised 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.
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Verena Vermeulen
Scientific Communication Manager