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Test Laboratory
DOT GmbH has established a fully-equipped modern test laboratory for physical, chemical and biological analysis as well as microbiological-hygienic testing. Our highly qualified laboratory team consists of engineers, laboratory technicians and other skilled professionals. We are able to provide a wide range of testing services for stakeholders in medical and scientific institutions by combining professional expertise with technical capabilities.
We can draw on many years of experience as an internal DOT GmbH laboratory. We also offer specific support for optimum product development and successful market introduction.
Our test laboratory is certified according to DIN EN ISO / IEC 17025:2018 and has been integrated into the quality management system of DOT GmbH that is certified in line with ISO 13485. The respective range of tests performed under accreditated conditions can be found in our accreditation certificate.
Advantages for our customers
- Many years of experience in the field of laboratory analysis for own medical devices
- Modern technical equipment (e.g. HPLC, universal testing machine, GC, TOC, microscopes)
- Availability of latest research findings due to partnerships with university collaborative projects
- Flexible implementation of customer requirements
Service range of Test Laboratory
Physical Methods:
- Measurement of roughness
- Rockwell indentation test
- Measurement of the tensile strength
(adhesion as well as shear strength) - Coating thickness measurements
(eddy current method, cross section procedure) - Measurement of porosity
- Determination of microhardness
- Test for particulate contamination (invisible particles)
- Test for packaging material (dye penetration, seal strength, peel test, O2 measurement)
Chemical-analytical methods:
- Recording of FT-IR spectra
- Determination electrical conductivity and pH
- Concentration determination of Paclitaxel and Sirolimus via HPLC
- Various photometric concentration determinations (e.g. soluble silicate, copper or phosphorus)
- Different titrations
- Color determination of metal samples
- Sieve analysis
- Measurement of surface-active substances (tensides)
- Determination of water-soluble organic residues (TOC)
- Determination of non-water-soluble organic residues (THC)
Microbiological-hygienic testing:
- Determination of total bacterial count
(e.g. surfaces, air, water samples) - Determination of the population
of microorganisms on a product (Bioburden) - Sterility testing
- Antimicrobial efficacy testing
- Bacterial endotoxin testing
- Cytotoxicity testing
Biological test:
- Cytotoxicity testing
Your questions
Our laboratory team will be happy to help you
with any questions you may have relating
to testing medical devices, active ingredients and their starting materials as well as preparing risk analyses and clarifying quality management questions.
DOT Test Laboratory Website
Would you like to get additional information on analytics?
Find out more at DOT-Analytiklabor-MP.de.
