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Tentamus Pharma & Med Deutschland GmbH

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Tentamus Pharma & Med Deutschland GmbH company portrait

Tentamus Pharma & Med Deutschland GmbH

Tentamus Pharma & Med Deutschland GmbH (TPMD) is a new brand in the Tentamus Laboratory Group network. TPMD was created from the merger of the bioanalytical testing laboratories Tentamedix, BLS-Analytik and DSI-pharm. The combination of the highly specialised laboratory units enables an expansion of individual possibilities. Thus, TPMD offers a sophisticated bioanalytical range in the field of biological safety testing of medicinal products and biological substances in general with a strong focus on biological and microbiological testing of medical devices.

TPMD is GMP certified and accredited according to ISO 17025.


Accredited Medical Device Testing according to the DIN EN ISO 10993

  1. Determination of Cytotoxicity in vitro (ISO 10993-5 / USP 87)
  2. Pyrogen testing: LAL- and Monocyte Activation Test (Ph. Eur. 2.6.14 / 2.6.30; ISO 10993-11)
  3. Determination of Bioburden and product specific recovery (ISO 11737-1 / 2)
  4. Skin testing on reconstructed human epidermis in vitro (Irritation and Corrosion): ISO 10993-10 / 10993-23  / OECD TG 431 / 439)
  5. Determination of Skin Sensitisation in vitro: DPRA, KerationSens- and h-CLAT-Assay (OECD TG 442c / d / e)
  6. Determination of Hemocompatibility (ISO 10993-4) on human full blod in a dynamic and static model including determination of hemolysis, coagulation and immune activation in several tests
  7. Determination of Genotoxicity (ISO 10993-3) Ames test & Micronucleus assay
  8. Determination of occular Irritation in vitro (OECD TG 492 / OECD TG 460)

 

Tentamus Pharma & Med Deutschland GmbH > Zertifikate

ISO 17025 / 10993 akkreditierte / GMP zertifiziert

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