Specialized Analytical Services for Regulated Industries

Project Description

1. Medical Devices – Biocompatibility & Chemical Characterization

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This project focuses on guiding medical device manufacturers through biological safety evaluation, including:

• Chemical characterization of materials in compliance with ISO 10993-18

• Extractables and leachables testing (organic, inorganic, particulates)

• Biocompatibility assessments including cytotoxicity, irritation, sensitization, and systemic toxicity (ISO 10993-5, -10, -11)

• Cleaning residue analysis in line with ISO 19227: total hydrocarbons, TOC, heavy metals, and particulate contamination

• Physicochemical surface analysis (ISO 10993-19) and degradation studies (ISO 10993-13/14/15)

• Nanomaterials analysis in compliance with ISO 10993-22 and Cosmetics Regulation 1223/2009

These services are particularly valuable for OEMs seeking to validate and register products under EU MDR, FDA, and Asian regulatory frameworks.

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2. Pharmaceutical and Biopharma Testing

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The laboratory assists pharmaceutical manufacturers and biotech companies with analytical development and GMP-supportive services such as:

• Method development and validation per ICH Q2/Q6B for biotherapeutics (mAbs, peptides, oligonucleotides)

• Structural and physicochemical characterization (peptide mapping, glycosylation, size variants, thermal stability, intact mass)

• Impurity profiling (elemental impurities per ICH Q3D, residual solvents per ICH Q3C, nitrosamines, aggregates)

• Raw material deformulation and stability testing

• Extractables & Leachables studies for packaging and process contact materials (USP <1663>/<1664>)

These services support both early-phase development and post-market surveillance.

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3. Nanomaterials & Cosmetic Applications

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Expertise extends to nanoscale characterization, particularly for materials used in cosmetics, medical formulations, and advanced coatings. Capabilities include:

• SEM-FEG, BET, SP-ICP-MS, XRD, DLS for morphology, particle size, surface area, and crystallinity

• Regulatory consulting for REACH, INCO, EFSA, and ISO compliance

• Substitution studies and deformulation of complex cosmetic and polymeric matrices

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4. Industrial & R&D Support for Polymers and Composites

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This project also involves analytical services for industrial materials, with a focus on:

• Thermoplastics, elastomers, adhesives, and resins (PE, PP, PVC, EPDM, PTFE, etc.)

• Additive and impurity identification (plasticizers, catalysts, degradation products)

• Compatibility and aging studies between materials and solvents/fluids

• Root cause failure analysis, particle ID, and surface contamination investigation

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Strategic Role of Passy Business

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Passy Business facilitates access to these specialized services by acting as a qualified entry point for technical discussions and commercial onboarding. Our involvement ensures alignment between local market requirements and regulatory expectations, while preserving the direct relationship between the manufacturer and the laboratory.

This ongoing engagement reflects our commitment to supporting compliant innovation, helping industry stakeholders accelerate product development and secure global regulatory approvals with robust and traceable data.