Laboratory for Analysis of Biomedical Materials

The Laboratory for Analysis of Biomedical Materials performs the assessment of biocompatibility of biomedical materials applied in regenerative and natural medicine, including microbiological analyses using innovative methods for detection and identification of bacteria and their metabolites, as well as histopathological analyses of biological materials implantation sites and their hemocompatibility

Activity area:

The microbiological purity of biomedical products and materials is crucial for the product safety, quality and compliance with various regulations for biomedical products and materials worldwide. Such products may get contaminated during both their production and use. Therefore, they have to undergo both testing during the production process and post-manufacturing tests. What’s more, their potential preservation system must be verified to ensure contamination prevention once the product has been opened and used.

Each batch of manufactured products should be tested to confirm that the products do not exceed the permissible limit(s) of microorganisms and are free from various pathogenic agents at the time of production and before their introduction on the market.

Once on the market and used by consumers, the products preservation systems should warrant their safety despite being constantly exposed to potentially harmful microorganisms in the surrounding environment and through physical contact with human skin.

Total count of microorganisms and pathogens

Before launching in the market, each batch of products should be appropriately tested  in the quality assurance procedures to determine whether it meets pre-defined criteria, including product quality and microbiological purity.

EU requirements for the necessary tests to determine the microbiological quality of products are described in the SCCS Notes of Guidance for the Testing of Cosmetic Substances and their Safety Evaluation. We offer all the tests listed in the guidelines and they are all carried out in accordance with the relevant international ISO standards.

We operate in accordance with the relevant international standards:

• EN ISO 16212 – enumeration of yeast and mould,
• EN ISO 21149 – the total microorganisms count,
• EN ISO 22718 – detection of Staphylococcus aureus,
• EN ISO 22717 – detection of Pseudomonas aeruginosa,
• EN ISO 18416 – detection of Candida albicans,
• EN ISO 21150 – detection of Escherichia coli.

We also carry out test of the effectiveness of preservatives used for microbiological protection of biomedical products and materials before the original packaging is opened and throughout the period of use by the end user.

Challenge Test enables the assessment of the efficacy of preservatives used against microbiological contamination. The challenge test is a procedure in which a product is challenged by exposure to specified types of bacteria and fungi in laboratory conditions to obtain numerical data on the growth of micro-organisms. The result is the number of microorganisms in the contaminated product calculated logarithmically at specified time intervals (typically 2, 7, 14 and 28 days).

The test begins with a culture of the following microorganisms: Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Candida albicans and Aspergillus brasiliensis (Aspergillus niger) and then the number of microorganisms is determined in accordance with reference methods in laboratory conditions.

• Pseudomonas aeruginosa ATCC®9027 
• Staphylococcus aureus ATCC®6538 
• Escherichia coli ATCC®8739 
• Candida albicans ATCC®10231 
• Aspergillus brasiliensis (A. niger) ATCC®16404 

Our laboratory performs Challenge Tests in accordance with the European Pharmacopoeia 5.1.3 or ISO 11930 standards at the customer’s request.

We also determine the microbiological potential of the sample.