In Vitro Testing Services

 

Nelson Labs Europe’s In-Vitro Testing Services for Medical Devices

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. Nelson Labs Europe is well aware of the scientific relevance of in-vitro testing, which has led to major investments in this department, offering a complete panel under GLP and GMP conditions.

 

Biocompatibility ISO 10993/FDA  in-vitro testing services:

  • Cytotoxicity testing:
    • Qualitative testing: USP <87>, AGAR Diffusion Method
    • Quantitative testing: ISO 10993-5: XTT method
  • Genotoxicity testing:
    • Ames test: ISO 10993-3

 

Nelson Labs Europe’s Microbiological Testing Services for Medical Devices

Nelson Labs Europe'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 with trained professionals that can assist with both routine testing requirements as well as complex microbiological evaluations.

Nelson Labs 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 developed:

  • 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 Support
    • Disinfectant Efficacy Studies
    • Particulate Analysis
    • Penicillin Assays

At Nelson Labs Europe, we evaluate each study on a case-by-case basis to find the right solution relevant to your product or process. Nelson Labs Europe will provide you with results at cost-effective prices for your product(s).

Contact:

 

Nelson Labs Europe
Romeinsestraat 12
B - 3001 Leuven
+ 32 16 40 04 84

InfoEurope@nelsonlabs.com

 

Ms. Cindy Claes
Customer Service Medical Device

ciclaes@nelsonlabs.com

Nelson Labs Europe | In Vitro Testing Services
biocompatibility, molecular biology, virology, metabolism, genetic toxicology, molecular toxicology, immunotoxicology, cytotoxcity, assays, binding assays, preclinical in vitro services, in vitro studies, contract research organziation, CRO,