COVID-19 Human Test –
Tentamus Japan

The Tentamus Japan labo­ra­tory is certi­fied for sampling, prepa­ra­tion, testing and reporting for coro­n­avirus in human saliva. The sample is taken directly into a sample vial before trans­port to the labo­ra­to­ries for testing.

Results can be deliv­ered typi­cally within 24 hours.

The test samples are measured by the accu­rate PCR (poly­merase chain reac­tion) method recog­nised by inter­na­tional health agencies.

Testing of Surfaces, Face Masks, Consumer Goods & Medical Devices

We provide you with suit­able swabs with which you can take samples of:

  • Sales coun­ters, door handles, light switches, work objects, keyboards, shop­ping trol­leys, etc.
  • Toys, tooth­brushes, pack­aging mate­rials, etc.
  • Respi­ra­tory masks, protec­tive clothing, etc.
  • Used or reprocessed protec­tive masks

These samples are then analyzed for SARS-CoV‑2 in our labo­ra­to­ries for you. Within 3 days after receipt of the samples, you will receive the results from us!

Testing of Medical face masks according to EN 14683-2019

According to the ISO EN 14683:2019+AC:2019, surgical masks and medical face masks, in general, should fulfill defined safety stan­dards before being placed on the Euro­pean market.

To fulfill these criteria Tentamus offers the following testing strate­gies in compli­ance with ISO 14683:

  • Bacte­rial filtra­tion effi­ciency (BFE)
  • Breatha­bility
  • Splash Resis­tance
  • Biocom­pat­i­bility
  • Micro­bi­o­log­ical Safety
  • Bioburden
  • Product Specific Pyrogenicity

Medical Devices

The biolog­ical safety of medical devices is essen­tial not only during the times of the Corona pandemic. Tentamus offers a sophis­ti­cated and accred­ited plat­form for biolog­ical safety testing of medical devices within the frame­work of the DIN ISO 10993 comprising the following test platforms:

  • Chem­ical charaa­ter­i­za­tion of Medical Devices (ISO 10993 – 18)
  • Deter­mi­na­tion of cyto­tox­i­city in vitro (ISO 10993 – 5)
  • Deter­mi­na­tion of Bioburden (ISO 11737−1÷2)
  • Deter­mi­na­tion of Bacte­rial Endo­toxin – LAL (Ph. Eur. 2.6.14)
  • Deter­mi­na­tion of Pyro­gens – MAT (Ph. Eur. 2.6.30)
  • Deter­mi­na­tion of Skin Irri­ta­tion (OECD TG 439 / ISO 10993 – 23 as draft)
  • Deter­mi­na­tion of Skin Sensi­ti­za­tion (OECD TG 442d/​e
  • Deter­mi­na­tion of Hemo­com­pat­i­bility (ISO 10993 – 4)
  • Deter­mi­na­tion of Geno­tox­i­city (ISO 10993 – 3)

Testing of Disinfectants for Hands or Surfaces

Regu­la­tory compli­ance, physio-chem­ical analysis as well as the effi­cacy testing of bacte­ri­cidal, fungi­cidal, viru­cidal prop­er­ties of disin­fec­tants, and hand sani­tizers are essen­tial for manu­fac­turers and health­care providers.

For autho­riza­tion purposes regarding bringing hand sani­tizer and surface disin­fec­tants to the market, Renolab holds a Good Labo­ra­tory Prac­tice (GLP) certifi­cate, and is certi­fied by the Italian Ministry of Health to provide the following services:

  • Complete qual­i­ta­tive and quan­ti­ta­tive compo­si­tion of formulae
  • Stability test in compli­ance with CIPAC method­olo­gies (i.e. CIPAC MT 46.3)

Product Analytics & Market Release of Hydroxy-Chloroquine & Chloroquine etc.

In order to secure the supply of crit­ical drugs in Germany and Europe, the phar­ma­ceu­tical labo­ra­to­ries of the Tentamus Group support phar­ma­ceu­tical compa­nies with:

  • Analyt­ical method transfers
  • In-process controls
  • Cleaning vali­da­tions
  • Quality controls
  • Stability studies
  • Release analytics
  • Batch certi­fi­ca­tion via a sepa­rate qual­i­fied person (QP)

Contact us:

Ralf Sibbing
pharma@​tentamus.​com

Tentamus Watcher:
Detecting & Monitoring Coronavirus in Waste­water

Tentamus Watcher a web tool capable of combining the results of the analysis of the coro­n­avirus (SARS-CoV‑2) in waste­water together with indi­ca­tors of health evolution.

The soft­ware gener­ates graphics and visual infor­ma­tion about the evolu­tion of the coro­n­avirus in cities and munic­i­pal­i­ties. It also provides alerts of possible outbreaks. There­fore, the tool allows public author­i­ties to antic­i­pate and improve the deci­sion making.

The detec­tion of mild or asymp­to­matic cases through waste­water testing has become a funda­mental epidemi­o­log­ical tool for early warning of the pres­ence of SARS-CoV‑2, both at the present time and in possible outbreaks or second waves of infection.

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