Toxikon Europe N.V. of Leuven at COMPAMED 2017 in Düsseldorf -- MEDICA Trade Fair

Toxikon Europe N.V.

Romeinsestraat 12, 3001 Leuven
Belgium

Telephone +32 +32 16 400484
Fax +32 +32 16 401304
info@toxikon.be

Hall map

COMPAMED 2017 hall map (Hall 8a): stand H15

Fairground map

COMPAMED 2017 fairground map: Hall 8a

Our range of products

Product categories

  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.01  Analytical methods development
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.03  Biocompatibility studies

Biocompatibility studies

  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.12  Microbiological studies
  • 13  Services
  • 13.02  Testing, certification, quality assurance
  • 13.02.03  Testing services

Our products

Product category: Testing services

Extractables and Leachables Services

Toxikon Europe offers a comprehensive approach towards Extractables / Leachables testing for the pharmaceutical industry. Our approach combines a technical and analytical expertise, polymer knowledge, understanding of regulatory requirements, all combined in a tailored approach to our customers.

ANALYTICAL EXPERTISE
Toxikon Europe is equiped with the state-of-the-art analytical technology, such as:
  • Headspace coupled to gas chromatography with a mass spectral detection (HS-GC/MS)
  • Gas chromatography with a mass spectral detection (GC/MS)
  • Programmable temperature vaporizer gas chromatography with a mass spectral detection (PTV-GC/MS) 
  • Liquid chromatography with a diode array detection combined with mass spectral detection (HPLC-UV/MS)
  • Liquid chromatography with multiple order mass spectral detection (LC/MS/MS)
  • Inductively coupled plasma with an optical emission detection (ICP-OES)
  • Ion Chromatography (IC)
  • Graphite Furnace - Atomic Absorption Spectroscopy (GF-AAS)
  • Infrared spectrophotometry (FTIR)
  • UV/VIS- Spectrophotometry
  • Total organic carbon analyzer(TOC)
  • .........
All instruments are dedicated to – and the methods are optimized for – extractables and leachables testing for the pharmaceutical industry, which requires all analytical equipment to be fully qualified (IQ/OQ/PQ).

In addition to the standard Extractables and Leachables testing programmes, Toxikon Europe can offer its assistance in the elucidation of structural information for critical compounds, using GC-ToF-MS, LC/MS-Orbitrap, LC-ToF-MS, FT-MS or NMR.

Because of the high importance of a unique identification of material impurities during extractable and leachable studies, Toxikon Europe has built up a “library” of more than 1000 reference standards, relevant to trace impurity testing in polymer and rubbers. These reference standards are used to confirm the identity (via retention time or mass spectral confirmation) of the extractable / leachable compounds.

Toxikon Europe also offers capacity for storage under controlled temperature and humidity for a variety of different storage conditions, this to support the stability programme for leachable studies. The climatic chambers are fully qualified and are monitored via a central data logging system.

Our Analytical expert team has a broad experience in method development and validation of long list of trace impurities (leachables) in a variety of pharmaceutical matrices, ranging from aqueous buffered saline solutions, over more complex pharmaceutical formulations (e.g. containing Polysorbate, PEG, protein solutions) and even very complex matrices (e.g. oily solutions, syrups, ointments).

POLYMER KNOWLEDGE & REGULATORY GUIDELINES
Although E/L-trace analysis testing often poses significant challenges to the analytical development team and therefore requires a high level of analytical expertise, it is of equal importance to have a thorough understanding of polymer and rubber knowledge,together with a profound knowledge on the global regulatory requirements per type of application. This combined expertise is of high importance in both the development phase of a testing strategy for a specific E/L project, as well as to understand and interpret the obtained analytical results and to assess these data from a regulatory point of view.

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Product category: Microbiological studies

Microbiology Services

Toxikon’s Microbiology Department effectively collaborates with clients to develop customized study protocols to meet your specific needs, for more than 10 years. With our strategy, we strive to provide services with state-of-the-art equipment and technical expertise to generate timely reports with quality data to support your products.

Our Microbiology Services include, but are not limited to routine lot release programs, microbial limit, bioburden, endotoxin and sterility testing.

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Product category: Analytical methods development, Microbiological studies, Testing services

In Vitro Testing Services

The importance of in-vitro testing as part of the qualification as well as the registration process has been highlighted in the latest regulatory guidances. Toxikon Europe is well aware of the scientific relevance of in-vitro testing, which has lead to major investments in this department, offering a complete panel under GLP and GMP conditions.

Biocompability ISO 10993/FDA  in-vitro testing services:
Cytotoxicity testing: Qualitative testing: USP <87>, AGAR Diffusion Method
Quantitative testing: ISO 10993-5: XTT method

Genetoxicity testing: Ames test: ISO 10993-3

Toxikon’s Microbiological Testing Services for Medical Devices
Toxikon's Microbiology department offers an extensive array of services to meet the compliance challenges facing the industry today. The state-of-the-art facilities are well equipped and trained professionals that can assist with both routine testing requirements as well as complex microbiological evaluations.

Toxikon Europe offers a variety of microbiology assays that are related to process control and lot release testing:
  • Sterility testing (including validation projects)
  • Bioburden (including VD-Max validation programs)
  • Bacterial Endotoxin Testing (including validation programs)
Besides routine testing, tailor made programs have been developped:

  • Endotoxin Retention Studies
  • Anti-Microbial efficacy determination of wound dressings (Time Kill Assays)
  • Antibiotic Efficiency Test (Zone of Inhibition Assay)
Our services include (but are not limited to):
  • Bioburden
  • Bacterial Endotoxin LAL (Gel Clot, Chromogenic, Turbidimetric)
  • Microbial Challenge
  • Microbial Identification
  • Preservative Effectiveness
  • Sterility
  • Lot Release Testing
  • Bacterial Adhesion
  • Reusable Device Validation
  • Antimicrobial Assays
  • Sterilization Validation
  • Cleaning Validation
  • High Level Disinfection Validation
  • Water System Validation (full analytical and microbiological components)
  • Full Compendial Testing
  • Environmental and Manufacturing QC SupportDisinfectant Efficacy Studies
  • Particulate Analysis
  • Penicillin Assays
At Toxikon, we evaluate each study on a case-by-case basis to find the right solution relevant to your product or process. Toxikon will provide you with results at cost-effective prices for your product(s).

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Product category: Analytical methods development, Testing services

Chemical Characterization

Toxikon’s Extractables and Leachables testing for Medical Devices
Set up of chemical characterization testing

The importance of chemical characterization testing for Medical Devices has been described in the ISO 10993-1 standard of 2009: “Biological evaluation of Medical Devices - Evaluation and Testing within a Risk Management System”. In this document, it was pointed out that the identification of material chemical constituents and consideration of chemical characterization (according to the ISO 10993-18 standard) of the materials shall precede any biological testing.

While biological testing on Medical Devices will provide clear pass/fail criteria for the tests performed, the material characterization tests will generate data on the potential chemical compounds that can leach out during the medical use of the device under “worst case” simulation conditions. It is clear that the analytical data, generated via a material characterization approach, may need more consideration with regard to the toxicological impact during the use of the device.

Based on its actual relevance, a consortium of Notified Bodies has elaborated a “Code of conduct” as a awareness campaign for medical device manufacturers to file its technical documentation, if necessary combined with analytical testing (Extractables studies).

The basic elements that need to be considered when making up a Material Characterization Study for Materials used in the manufacture of a Medical Device, are:
  • Selection of the extraction conditions (ISO 10993-12)Extraction Times
  • Extraction Temperatures
  • Extraction Vehicles
  • Analytical Equipment used
  • Initial Toxicological Assessment via a Threshold ApproachSetting Allowable Limits for migration compounds, based upon a TTC principle
  • How to translate TTC’s into analytical limits for evaluation
  • How to deal with the semi-quantitative nature of chromatographic “screening” tests
  • Consequences of the defined TTC levels on the required analytical sensitivity
Although a Material Characterization study may initially be an exhaustive exercise for the applicant, there are a lot of advantages that may arise once the study is completed:

It will allow creating a database of materials that may be used in other Medical Device applications.
Changing the composition of a material for a Medical Device may limit the amount of biocompatibility work, needed to document this change.
Changes in the intended use of a material (e.g. type of body contact, contact duration…) may be performed with a different TTC approach on the same analytical data.
 
Polymer impurities, migrating from the Device into the extraction Vehicle, may come from:
  • Plasticizers, colorants, antioxidants, lubrificants
  • Production products e.g. during molding, surface treatment, welding
  • Additives e.g. pigments, inks
  • Potential process contaminants e.g. Cleaning/disinfection/sterilization agents, machine contaminants
  • Degradation products during manufacturing and processing, transport, clinical use and storage
Polymer impurities, migrating from the Device into the extraction Vehicle, may come from:

Plasticizers, colorants, antioxidants, lubrificants
  • Production products e.g. during molding, surface treatment, welding
  • Additives e.g. pigments, inks
  • Potential process contaminants e.g. Cleaning/disinfection/sterilization agents, machine contaminants
  • Degradation products during manufacturing and processing, transport, clinical use and storage.
Polymers may release toxic compounds which can be removed from a medical device by the action of water or other liquids related to the use of the device (ISO 10993-17).

Our Expert Team will assist you with:
  • Designing the right testing strategy for your Device
  • Calculating the Thresholds of Toxicological Concern, relevant for your application
  • Interpretation of data
  • Reporting of data
  • Writing a comprehensive biocompatibility/Material Characterization Risk Assessment report, taking into account the medical/clinical use (amount mg/treatment), exposure time, age, pharmacokinetics etc…  These reports are generally accepted worldwide. 

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Product category: Biocompatibility studies, Microbiological studies, Testing services

In Vivo Testing Services

Toxikon’s In-Vivo Biocompatibility Testing Services for Medical Devices
The goal of in vivo testing medical devices is to determine the safety or biocompatibility of the device in a biological environment. 

Biocompatibility testing requirements comes into effect if a product is scheduled for Pre-Market Approval (PMA) or 510k submissions.  Biocompatiblity testing determines the biological reaction of a body to a product/device that comes in contact with it for a defined duration.

Toxikon has performed numerous safety studies, which has given us good experience and knowledge for many years.  All studies are performed in compliance with guidelines established by the regulatory agencies.  The protocols are designed to meet the regulatory requirements for ISO, USP, OECD and Japanese MHLW.

Toxikon offers expertise in the following product compliance testing:
Testing on raw materials for medical use compliance:
  • USP Class VI (Intracutanous , systemic and short term implantation)
  • ISO 10993 testing
  • GMP Screening evaluation testing 
Testing on final medical devices per ISO/FDA/MHLW:
  • Sensitization
  • Irritation/Intracutaneous Reactivity Tests 
  • Systemic Toxicity (Acute)
  • Toxicity Tests (Subacute to Chronic)
  • Implantation Tests
  • Carcinogenicity
  • Immunogenicity
  • Dermal
  • Ocular
Testing in support of Basic Research Phase (ESRS): Efficacy Surgical Research Services
  • Consulting
  • Space Rental
  • Physician Training/Bioskills lab
  • Early Discovery
  • Proof of Concept
  • Surgical Studies
  • Interventional Cardiology
  • Orthopedic Studies
  • Non-Routine Feasibility

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About us

Company details

Toxikon is a contract research organization (CRO). We contract and partner with biotech, pharmaceutical and medical device industries to deliver exceptional product development services from concept to final product.

At Toxikon, We Pledge:
To conduct the highest quality research and testing services in the industry;
  • To provide prompt, friendly, and timely services by a knowledgeable and highly-trained staff;
  • To be sensitive to special project needs and provide a detailed scope of services to be performed for every study/project;
  • To deliver studies/projects to sponsor satisfaction, in a timely and efficient manner;
  • To feature new services that represents the best current technology available;
  • To respond in a rapid, sensitive, and constructive manner to requests that will enhance your outsourcing experience;
  • To provide you with an experience that will encourage a continued partnership with Toxikon.

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