Our laboratory supports the work of R & D on innovative medical devices and examines their biocompatibility.
Service range
Currently, we perform most of the in vitro studies required by the ISO 10993 standard for certification for medical products.
We cooperate with the best research units in Poland. We are able to finish even the most complicated jobs thanks to the professionals and the laboratory equipment we possess.
We perform product testing for:
- cytotoxicity,
- sensitization,
- irritation/intradermal reactivity,
- acute toxicity,
- subacute toxicity,
- genotoxicity,
- implantation,
- hemocompatibility
The detailed scope of services offered:
In our laboratory we have equipment that allows us to perform even the most complex in vitro tests in the fields of biomedicine and molecular biology. The following tests can be performed in our laboratory:
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Cytotoxicity
Cytotoxicity testing of chemical compounds, as well as of medical devices (in accordance with ISO 10993-5: 2009 and ISO 10993-12: 2012). We carry out the following cytotoxicity tests of medical devices: extract, direct contact, agar overlay assay and filter diffusion.
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Genotoxicity
Genotoxicity testing of chemical compounds, as well as medical devices (in accordance with ISO 10993-3: 2003). Test is performed on mouse lymphoma cells.
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Irritation
To meet the trend of reducing the use of animals in experiments, we conduct the study of irritant chemicals on human skin models.
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Enzyme Immunoassay
Biomedical studies and diagnostic tests for detection of specific proteins in the test material – ELISA (eg. HBs or HIV).
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pH measurement
We routinely measure the pH of solutions using calibrated equipment.
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Bacterial endotoxin concentration
We determine the level of bacterial endotoxins in the test material (in accordance with Ph. Eur).
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Detection of Mycoplasma sp DNA
Eukaryotic cell cultures are often exposed to infection by Mycoplasma sp. Here, in our laboratory we detect the presence of bacteria in the testing materials.
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Other tests
A variety of laboratory equipment enables us to perform one-shot case studies, which are difficult to categorize: stability testing of ligating clips, protein assay (BCA and Bradford methods), chemical testing and analysis (eg. Glutaraldehyde), DNA Electrophoresis (PCR primer check) protein electrophoresis (SDS-PAGE), and many other tests in the field of biomedicine and molecular biology.
Full scope of our lab services
Biological Safety Testing - Biocompatibility
Biocompatibility of medical devices has to be evaluated in the view of the harmonized EN ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing”. The biological test methods applicable for respective medical devices are classified regarding to their nature and duration of contact. Below is a list of Biocompatibility tests:
- * Cytotoxicity (ISO 10993-5) – available now;
- * Irritation (ISO 10993-10) – available now;
- * Sensitization (ISO 10993-10) – available now;
- Systemic toxicity (ISO 10993-11) – available now;
- Subchronic toxicity (ISO 10993-11) – available now;
- Genotoxicity (ISO 10993-3) – available now;
- Implantation (ISO 10993-6) – available now;
- Haemocompatibility (ISO 10933-4) – available from June 2017.
* - mandatorily required for any medical device.
Biomedical Testing
Currently, we conduct research in the field of biomedicine and molecular biology. Extensive laboratory equipment allows us to analyze a number of cases. Below is a list of the most popular assays:
- Pyrogen testing;
- USP Biological Reactivity Tests;
- Antigen detection (IL-1?, ß-TG, C3a, etc.);
- Protein analysis (concentration, purity, spatial structure, pH, etc.);
- Organic solvent evaluation (concentration, purity);
Shelf Life Testing
Medical devices and packing systems have to remain stable during shelf life. Accelerated aging is a test method used to estimate the useful lifespan of a product when actual lifespan data in unavailable. The primary reason for using accelerated aging techniques in the qualification testing of a medical device is to introduce the product to the market at the earliest possible time.
Research and Development Services
We strongly support customer’s R&D projects using our knowledge and facilities. Our Research and Development services are tailor-made for each customer’s needs. Based on our experience and extensive cooperation with scientific institutions we have participated in many successfully finished R&D projects.
Additional services
Currently, our laboratory conducts in vitro studies in the field of biomedicine and molecular biology. When it is necessary to perform studies in vivo (with animals), we collaborate with appropriate centers and carry out such tasks successfully. We are specialized in in vivo studies of medical devices in accordance with the ISO 10993 standard. We also analyze chemical compounds and mixtures of substances.
On the basis of our experience and extensive collaboration with leading Polish scientists we also accept orders for specific material designation regarding medical devices - even class III devices for implantation!