26. November 2015

Medical Industry

Bioburden

Bioburden petri dish

You want to feel confident about the safety of your products and want to know about a possible contamination? Then get a Bioburden test from the BioLabs of senetics!

Bioburden is defined as the number of microbes, which can be found on a non-sterile surface. Since this contamination can easily happen during the production process, pharmaceutical and medical products are tested for quality purposes.

In our Biolab we conduct the testing of all kinds of materials and components regarding the total number of viable micro-organisms according to ISO 11737 -1:

  • Total microbial count on medical products (bacteria, yeast, fungi)
  • Membrane-filtration and plate count method
  • Microbial identification, if requested, with staining, PCR, MALDI-TOF and/or DNA sequencing

 

Biocompatibility

biological test laboratory: biocompatibility

You are planning to produce an implant that consists of an alloy or coating  that has not been used yet? We test the biocompatibility of your products according to ISO 10993 and check if the material is biological inert. Moreover, we make sure, that there will be no damage  to the surrounding tissue.

An important safety issue while developing medical products is biocompatibility. senetics offers you to perform different tests to ensure that your materials are biocompatible!

Biocompatible materials do not have a toxic or hazardous  effect on biological systems. As medical devices and implants are in direct contact with the surrounding tissue for a long time, they must not cause defense reactions of the immune system. After the German Medical Devices Act, medical devices must be tested extensively before being placed to protect the patients. We offer the following services:

  • Cytotoxicity testing according to DIN EN ISO 10993-3
  • Genotoxicity, carcinogenicity, reproductive toxicity according to DIN EN ISO 10993-5
  • Haemocompatibility according to DIN EN ISO 10993-4
  • Endotoxin testing according to DIN EN ISO 10993-11
  • …and much more on request!

 

Biomedical Testing

biomedical testing

Get your product tested now!

We support you with the planning and conduction of biomedical testing according to the guidelines of EWG and MPG. This includes the verification of clinical efficiency as well as the support with the implementation of clinical trials. Furthermore, the product specifications can be verified and the testing procedures and prototypes can be validated.

 

Disinfectant Efficiency Testing

Disinfectant Efficiency Testing

You developed a disinfectant and you are unsure about its efficiency? We help you by testing your product according to DIN EN guidelines!

Production rooms and laboratories in healthcare and medical and pharmaceutical facilities have to remain free from microorganisms to prevent contamination of the handled products. To guarantee a sterile environment, several disinfectants can be used.  Testing the efficacy of the desinfectant ensures the effectiveness of the used agents. The testing of your disinfectants is conducted according to the European guidelines (EN13704, EN13697, EN1276, EN1650)

 

Endoxin Testing

Developing medical products is not easy. Especially keeping the products endotoxine free is a very important and often demanding task. We support you by performing LAL surveys to prove that your product is safe!

Endotoxins are large Lipopolysaccharides, which are found in the outer membrane of Gram-negative bacteria. They cause severe immune responses in mammalians and have to be removed to avoid the contamination of experiments and toxicity of products. Especially in the pharmaceutical production, all traces have to be eliminated, since even small amounts will cause harm to humans.
Medical devices have to be proven endotoxin free according to the European Pharmacopoeia. The products are only allowed to have less than20 EU (Endotoxin Units). In our biolab we conduct the Limulus Amebocyte Lysate (LAL) assay to guarantee the safety of your products.

 

Microbial Identification

Microbial Identification shigella

Test your product for potential pathogenes and make it safe!

Identification of microbes and thereby of potential pathogens is essential for the safety of medical products and your health. We identify the microbes of your Bioburden testing and specify the results of your potable water with various methods:

  • Bacteria species identification (gram-staining, catalase-, oxidase-, koagulase-reaction)
  • DNA-sequencing
  • MALDI-TOF

 

Prediction of toxicity with QSAR-models

QSAR toxicity

During the daily life we are exposed to various chemicals as ingredients of different products. However, not all chemicals have been tested for their toxic effects. Never the less it is essential for the safety of medical devices to evaluate the potential toxicity of a material!

QSAR-models (Quantitative Structure Activity Relationships) can be used for the prediction of chemically-induced toxic effects and for the selection of materials. The chemical structure of the molecules is compared to a toolbox for predicting potential hazardous chemicals. The method is based on computational models and the relationships between toxic effects and chemical structures.

Therefore, the models are useful in the beginning of the development for the characterization of potential materials. Our QSAR services include:

  • Toxicity evaluation (optimize choice of material)
  • Safety evaluation report (toxicity report for componds)

 

Sterilizing Capability

biological test laboratory: sterilizing capability

You have a project and you need your product to be proven sterile?
Send us your request and we will test your prototype or product for its sterilizing capability according to DIN EN ISO 11737-2!

By sterilization, all forms of biological agents, like viruses, bacteria and fungi, which are possibly present on a products surface or inside fluids are removed or killed. A product is classified as sterile, if only one germ in one million products can be found. Since medical devices are applied on and in the human body, sterility is mandatory. We prove the sterility of your medical devices according to DIN EN ISO 11737-2 and Eu. Phr. 2.6.1.