Chemical characterisation
of medical devices

Tentamus Pharma & Med’s labo­ra­to­ries conduct chem­ical and instru­mental tests in order to analyse raw mate­rials, semi-finished goods and finished batches of medical devices. We perform qual­i­ta­tive and quan­ti­ta­tive limit and content deter­mi­na­tion for a wide variety of substances such as residual solvents, heavy metals and endo­toxins. We detect cont­a­m­i­na­tion with foreign matter and verify the sterility of medical devices.

Our instru­mental analytics methods

  • Atomic absorp­tion spec­trom­etry (AAS) using the following tech­niques: flame, nitrous oxide, graphite furnace, hydride and the corre­sponding diges­tion methods: acid diges­tion and microwave diges­tion to detect metals
  • Induc­tively coupled plasma mass spec­trom­etry (ICP-MS) for trace analysis of heavy metals such as mercury, lead or cadmium
  • Gas chro­matog­raphy (GC) with the following detec­tors: FID, NPD and MSD, e.g. deter­mi­na­tion of content and purity of phar­ma­ceu­tical raw mate­rials and finished prod­ucts, residual solvents, fatty acid composition

In vitro analytics
for medical device certification

At Tentamus Pharma & Med, we use cell culture-based in vitro tech­niques when carrying out func­tional bioas­says or effector cell assays in order to test and certify the biocom­pat­i­bility of medical devices (DIN EN ISO 10993). This allows us to examine devices for factors such as cyto­tox­i­city as well as skin irri­ta­tion and sensi­ti­sa­tion in various cell culture models.

We conduct ex vivo trials using fresh human blood (ISO 10993 – 4) in order to analyse human immuno­log­ical and inflam­ma­tory responses (e.g. haemol­ysis, blood coag­u­la­tion, comple­ment acti­va­tion) to medical devices.

Func­tional bioassays

  • Tests for in vitro cyto­tox­i­city (ISO 10993 – 5)
  • Tests for skin irri­ta­tion (ISO 10993 – 10/OECD 439)
  • Tests for skin sensi­ti­sa­tion (ISO 10993 – 10 / OECD 442 d/​e
  • Tests for ocular irritation/​corrosion (OECD 460)
  • Tests for ocular irri­ta­tion (OECD 492)
  • Tests for skin corro­sion (OECD 431)
  • Effector cell assays using various cell lines (cyto­tox­i­city, apop­tosis, ADCC, CDC)
  • Proliferation/​reporter gene assays
  • In vitro potency assays
pharma&med medical devices mikrobiologie Labor

Microbiological testing
for medical devices

Our micro­bi­o­log­ical depart­ment specialises in detecting microor­gan­isms such as aerobic and anaer­obic bacteria, bacte­rial viruses (bacte­rio­phages) as well as yeasts and moulds. We use clas­sical micro­bi­o­log­ical methods of enrich­ment, isola­tion and iden­ti­fi­ca­tion of specific microor­gan­isms to examine the sterility of raw mate­rials, inter­me­diate prod­ucts and ready-to-use batches of medical devices.

At Tentamus Pharma & Med, we perform micro­bi­o­log­ical tests such as pyrogen deter­mi­na­tion for each mono­cyte acti­va­tion test or bacte­rial endo­toxin tests in a GMP-compliant manner in accor­dance with the stan­dards and spec­i­fi­ca­tions of clas­sical phar­ma­copoeial tests.

We carry out clin­ical assays for the following purposes:

  • Deter­mi­na­tion of bioburden (Ph. Eur. 2.6.12, ISO 11737 – 1)
  • Detec­tion of specific bacteria (Ph. Eur. 2.6.13)
  • Pyrogen deter­mi­na­tion:
    • bacte­rial endo­toxin test (Ph. Eur. 2.6.14)
    • Mono­cyte acti­va­tion test (Ph. Eur. 2.6.30)
  • Micro­bi­o­log­ical testing of cosmetics in accor­dance with CTFA or ISO standards

In vitro biocompatibility testing
in accordance with DIN EN ISO 10993

Our methods for biocom­pat­i­bility testing of medical devices are vali­dated in accor­dance with DIN EN ISO 10993. We avoid animal exper­i­ments and have adopted the 3Rs prin­ciple (replace­ment, reduc­tion, refine­ment). Our tests are conducted in vitro. We use cell cultures to examine factors such as cyto­tox­i­city as well as skin irri­ta­tion and sensi­ti­sa­tion in accor­dance with the revised EU MDR and DIN ISO 10993.

Our analyt­ical proce­dures for testing biocompatibility:

In vitro deter­mi­na­tion of cytotoxicity

  • DIN ISO 10993 – 5/USP <87>
  • Read out: XTT/​neutral red/​MTT/​MTS
  • Toxi­city of diffusing substances through agar diffu­sion (USP <87>)
  • Deter­mi­na­tion of photo­tox­i­city (OECD TG 432)

In vitro irri­ta­tion and sensitisation

  • Skin irri­ta­tion on recon­structed human epidermis: ISO 10993 – 10 / 23 (draft) / OECD TG 439
  • ARE-Nrf2 Luciferase test method (Kerati­noSens assay): OECD TG 442d
  • Human cell line acti­va­tion test (h‑CLAT): OECD TG 442e
  • In vitro skin corro­sion: OECD TG 431

In vitro corro­sion and irri­ta­tion on ocular tissue

  • Recon­structed human Cornea-like Epithe­lium Test (RhCe): OECD TG 492
  • Ocular Corro­sives and Severe Irri­tants: OECD TG 460

Geno­tox­i­city

  • Bacte­rial reverse muta­tion test (AMES test):DIN ISO 10993 – 3/OECD TG 471
  • In vitro mammalian micronu­cleus test: DIN ISO 10993 – 3/OECD TG 487

Haemo­com­pat­i­bility

  • DIN ISO 10993 – 4
  • Static or dynamic process using human whole blood in a closed loop system
  • Integrity of red blood cells: haemol­ysis and deter­mi­na­tion of total and plasma haemoglobin
  • Cellular compo­nents of blood/​blood count
  • Effects on coag­u­la­tion: throm­bo­cyte count, human platelet factor 4 (hPF‑4), prothrombin (PT), fibrinogen (Fib), thrombin time (TT), throm­bin/anti-thrombin complex (TAT)
  • Acti­va­tion of the immune system: comple­ment factors C3a, C5a, Sc5b‑9

Deter­mi­na­tion of bacte­rial endo­toxins and pyrogens

  • Bacte­rial endo­toxin testing (BET): limulus amoe­bo­cyte lysate (LAL) test: Ph. Eur. 2.6.14: veri­fi­ca­tion and testing
  • Deter­mi­na­tion of non-endo­toxin pyro­gens (NEPs): mono­cyte acti­va­tion test (MAT): Ph. Eur. 2.6.30: veri­fi­ca­tion and testing

Bioburden and sterility

  • Deter­mi­na­tion of bioburden: ISO 11737 – 1, Ph. Eur 2.6.12: veri­fi­ca­tion and testing
  • Sterility testing of medical devices as part of a ster­il­i­sa­tion process: ISO 11737 – 2: veri­fi­ca­tion and testing

Gener­a­tion of extracts from and chem­ical char­ac­ter­i­sa­tion of medical devices

  • Gener­a­tion of extracts for biolog­ical and chem­ical char­ac­ter­i­sa­tion (DIN ISO 10993 – 12)
  • Chem­ical char­ac­ter­i­sa­tion of test samples using LC-MS, GC-MS, HS-GC-MS and ICP-MS (DIN ISO 10993−13÷−18)
  • Detec­tion of ethylene oxide residues (DIN ISO 10993 – 7)

In vivo testing

In addi­tion to our in vitro testing plat­form, we offer in vivo testing by qual­i­fied partner laboratories:

  • ISO 10993 – 2 – Animal welfare requirements
  • ISO 10993 – 6 – Tests for local effects after implantation
  • ISO 10993 – 10 – Tests for irri­ta­tion and skin sensitisation
  • ISO 10993 – 11 – Tests for systemic toxicity
  • ISO 10993 – 20 – Prin­ci­ples and methods for immuno­tox­i­cology testing of medical devices
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