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Biological safety and function of medical devices, supplements, materials and products

Products that are used to treat, to care, make a diagnose or improve or maintain health must be safe for the users. It is also required that the stated function of the products should be shown. So before a products is put on the marked the safety and function needs to be tested and documented.

Biological safety plan

We have thorough knowledge of regulatory requirements for many product categories and can help to design a biological safety plan and perform a risk analysis for your specific product based on its type of and duration of contact with the human body.

Material analysis

We offer testing and evaluation of the suitability of the materials to be used in different applications, outside of and inside the body. Tests according to ISO 10993 to determine the extractable and leachable compounds are combined with evaluation of the toxic effect of the extracted compounds. These tests are applicable for both materials and products. 

Cleanliness of medical products

An important aspect within the field of medical devices is the final cleanliness of the product, where residues of oils and particle contaminants from the manufacturing process or residues of detergents after cleaning may affect the final performance of the product. To assess this, we offer the following tests:

  • Particle release from active implantable medical devices (EN 45502-1:2015 clause 14.2, AAMI TIR42);
  • Verification of sterility of medical devices (ISO 15883, EN 556, ISO 11737, ISO 14937, ISO 17664, ISO 17665, ISO 13402);
  • Cleanliness of medical devices and efficiency of cleaning processes (ISO 15883, SIS-TR 3:2002, AAMI-TIR12, AAMI-TIR30, ASTM-D7225, ASTM-F3208, ASTM-F2459).

Apart from standardized methods, we are also experienced in setting up novel methods and models, both in vitro, ex vivo and in vivo, based on publications or customer´s needs to test biological function and safety of the specific product.

Microbiology 

We offer functional testing of antimicrobial effect of pharmaceuticals, procedures, materials and devices with a broad range of in vitro methods as e.g.  minimal inhibitory concentration (MIC), minimal microbiocidal concentration (MMC), antimicrobial activity under dynamic contact conditions (ASTM E2149-13a), biofilm methods and ex vivo skin infection models. We also offer the AMES assay (bacterial reverse mutation according to OECD 471) and custom-designed methods. Tests are offered both on bacteria, spores and yeast, including antibiotic resistant strains. 

Validated instructions for decontamination of reusable products are a requirement according to the new EU Medical Devices Regulation (MDR) and we are experienced in helping developing instructions for use  (IFU) and validating their efficiency in cleaning, disinfection and sterilization in autoclave. Cleanliness is verified with e.g. protein analysis, endotoxin analysis, log-reduction of bacteria/spores, sterility and SEM-EDX.

Cellbiology within GLP 

We are the only laboratory in Sweden to offer cytotoxicity testing (ISO 10993-5:2009 Annex C) and skin irritation testing in vitro (OECD TG 439) performed according to the quality system Good Laboratory Practice (GLP). Our GLP-statement covers “In vitro toxicity studies using cell systems and tissues”, and we are continuously expanding our offer concerning in vitro methods. 

Our GLP-approved laboratory is also actively involved in international initiatives aiming to replace animal testing. As the only Swedish representative in the EU-NETVAL network hosted by EURL ECVAM – the EU reference laboratory for alternatives to animal testing, we are participating in validation studies and contributing to other work performed in the area. The laboratories in EU-NETVAL perform the necessary validation of methods required before incorporation in OECD test guidelines or ISO standards. Examples of validation studies where we have participated are for test methods detecting endocrine disrupting chemicals: AR-CALUX (2015-2018) and the on-going study concerning thyroid disruptors (2018-). We are also active in validating and developing new standards for medical devices, such as the ISO 10993-23, an in vitro based skin irritation testing method. 

Cell biology and advanced therapies

Besides offering standardized GLP methods, we are experienced in setting up new methods based on customer´s needs. Our broad knowledge in cell and molecular biology qualify us to participate in the development process with both guidance and practical testing. Our core competence is to select, adapt, validate and implement methods that provide answers to the questions asked, in collaboration with the customer. We also perform tests on how processes impact product characteristics such as quality. Examples of analyses performed are, pro-/anti-inflammatory potential in cell culture (via NF-ƘB pathway), cytotoxicity (membrane integrity via protease activity, LDH and  cell free DNA, metabolic activity, ATP amount etc. ), proliferation, permeability (Caco2 and EpiIntestinal) in small intestine, other analysis in small intestine (gene expression, cytokine release, toxicity, active transport, membrane integrity). In addition, we can offer Fluorescence-Activated Cell Sorting (FACS) and multi-color flow cytometric analysis. We are continuously expanding our panel of cell lines to set up new methods and can be a speaking partner from the start to interpretation of results.

In Vivo 

In order to initiate necessary clinical tests on both medical devices, supplements and  pharmaceuticals, the biological safety and function need to be known and well documented. For this purpose, we have a number of different animal models available within wound infections and toxicology. In addition, we are skilled to set up and implement new models upon customer´s needs. We have broad experience to facilitate the entire process from application for ethical approval, performance of the animal study to evaluation and interpretation of results.

Molecular biological analyses

We offer molecular biological analysis on both gene and protein level. Such investigations can for example be used to study how a drug affects its receptors, whether  a specific compound activates a certain intracellular signaling pathway, or how implant surfaces adhere to surrounding environment and if they activate apoptosis or induce cancer. We can supply custom design of project within the area of real-time PCR (qPCR), nucleic acid extraction, and related technologies for analyzing genetic material. In addition we offer immunoassays in which up to 100 protein biomarkers, nucleic acids or peptides can be measured simultaneously in growth medium or serum. We have methods for inflammation, different disease models, cell signaling, growth, apoptosis, toxicity etc. You may select from already existing models and panels or design your own multiplex assay according to your specific product.