Nelson Labs Europe – Leuven, Belgium

Based in Belgium, Nelson Labs Europe is a Center of Excellence providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries.

Nelson Labs Europe supports pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify Container/Closure Applications and Pharmaceutical Production Equipment from an Extractables & Leachables perspective.

Nelson Labs Europe is ISO 17025 accredited and GLP-certified. Nelson Labs Europe has received a GMP accreditation from the European Authorities. Nelson Labs Europe is FDA registered. In 2017, Nelson Labs Europe was successfully audited by the FDA.

On October 31, 2017, Nelson Labs acquired Toxikon Europe N.V. and now operates as Nelson Labs Europe.

Visit the Nelson Labs Europe web page for more information.

Testing Services Available

Biocompatibility & Toxicology

• Cytotoxicity
• Physiochemical USP Plastics Tests

Chemical Analysis

• Compendial Testing (USP/EP/JP)
• Drug Potency (Active Ingrediënt and Dosage Forms)
• Organic Impurities Identification
• Analytical Method development and validation
• In-use stability testing for drug-device combinations
• Water System Testing – TOC/Conductivity/ph/Particulates

Clinical Reprocessing Validations

• Cleaning Validation – Reuse Device
• Disinfection Validation – Reuse Device
• Sterilization Validation – Reuse Device

Extractables & Leachables

• Extractables & Leachables for Medical Devices
• Material Characterization Screens for Raw Materials
• Extractables & Leachables for Pharmaceuticals
• Physiochemical USP Plastics Tests

Facility & Process Validation

• Material Characterization Screens of Raw Materials

Packaging Solutions

• Container Closure Integrity – Dye Immersion & Bacterial Immersion

Protective Barriers & Material Performance

• Viral Penetration Test

Sterility Assurance

• Bacterial Endotoxins Test
• Microbial Examination of Nonsterile Products
• Mycoplasma Testing – PCR & Traditional (only traditional)
• Particulate Analysis
• Product Bioburden – Medical Device
• Product Sterility – Isolator
• Radiation Quarterly Dose Audits (QDAs)

Combination Products Testing

Impurities Identification in Drug Components and APIs

Stability Studies – Pharmaceutical

Method Development – Pharmaceutical

Microbiological Testing