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Specialized Analytical Testing Services for OINDPs & Medical Devices

Accelerate your product development with world-leading inhalation expertise, ISO 17025 accredited biocompatibility testing, and pharmacopeia-aligned aerosol characterization.

Analytical service at Emmace lab by Mårten Svensson
Medical Device testing

Emmace Consulting AB is an independent Contract Research Organization (CRO) based in Lund, Sweden, within the Medicon Valley region. Founded by inhalation scientists, Emmace operates an ISO/IEC 17025:2018 accredited laboratory (SWEDAC Accreditation No. 10501) specializing in medical respiratory device biocompatibility testing according to ISO 18562:2024. 

In addition, Emmace provides specialized non-accredited analytical testing and strategic advisory services for oral inhalation and nasal drug products (OINDPs), including DPIs, pMDIs, soft mist inhalers, nebulizers, and nasal sprays.

Service Overview & Quality Scope Directory

Our laboratory services are organized into three specialized divisions, clearly structured by regulatory and accreditation boundaries:

1. Medical Device Biocompatibility – ISO 17025 Accredited

Testing of breathing gas pathways in medical devices according to ISO 18562-2 (particulate matter), ISO 18562-3 (volatile organic substances), and ISO 18562-4 (condensate determination).

2. Inhaler, Nebulizer & Nasal Device Testing – Pharmacopeial / Non-Accredited

Comprehensive aerosol physics and pharmaceutical performance testing aligned with European Pharmacopeia (Ph. Eur. 2.9.18), US Pharmacopeia (USP <601> / <1601>), and FDA Product Specific Guidelines (PSGs).

3. Advanced Aerosol & Physical Characterization – Non-Accredited

Cutting-edge physical aerosol science, including Aerosol Mass Spectrometry (AMS), Faraday Box electrostatic analysis, and Aerodynamic Particle Sizer (APS) counting.

Detailed Service Portfolio

1. Medical Device Testing – ISO 17025 Accredited

Ensure compliance for medical devices that are in in-direct contact with breathing pathways, such as ventilators, anesthesia systems, breathing masks, nebulizers, and heat moisture exchangers (HMEs).

Biocompatibility evaluation of breathing gas pathway devices

2. Inhaler, Nebulizer & Nasal Device Testing – Pharmacopeial / Non-Accredited

Customized, flexible analytical testing for small biotech startups to global pharmaceutical leaders.

Preparing for APSD testing

3. Advanced Aerosol Research Services – Non-Accredited

Advanced analytical capabilities for complex formulation troubleshooting and fundamental aerosol physics:

Particle counting and time of flight (APS) testing at Emmace Lab
Development and Understanding of Dry Powder Formulations for Inhalation at Emmace lab with Kyrre Thalberg and Elisabet Rappe

Strategic Advising: Beyond Laboratory Data

Testing alone does not solve complex delivery challenges. Supported by senior scientists with hundreds of years of combined experience across Big Pharma, academia, and leading CROs, Emmace offers strategic advising in:

Equipment of inhalation laboratory

Techniques for chemical analysis of inhalation drug products:

  • Impactors (aerodynamic particle size distribution)
    • Next generation impactor (NGI)
    • Andersen cascade impactor (ACI)
    • Multi-stage liquid impinger (MSLI)
  • Fast screening impactor (FSI)
  • DUSA (delivered dose) or similar set ups
  • Mixing inlet
  • Breath Profile Generator F-SIG 6300 (Replay of inhalation profiles, both bolus and tidal)
  • Anatomical throat models for lung dose prediction (OPC (S, M, L), Alberta, VCU (S, M, L)
  • Nasal casts (in sections and as complete models), different materials
  • Actuation force tester
  • Mechanical hand for pMDI and SVN (Dose fire coordination with inhalation profile)
  • Modified ACI for capturing lung dose to dissolution testing
  • Dissolution paddle bath
  • Malvern Spraytec Laser diffraction system equipped with inhalation cell
  • Spray Pattern and Plume Geometry (Envision system from Oxford lasers)
  • Aerodynamic particle sizer (APS) model 3321
  • HPLC (CDS: Cromeleon, Vanquich, HP1100)
  • Cary 50 UV-vis
  • Particle counters in air
  • Faraday cages set up (electrostatic measurement)
  • + “standard” lab equipment, e.g., balances, pH-meter, Temp/RH meter, Trig box, flow meter, pressure drop meter, centrifuges
Cascade Impactor – APSD – testing at Emmace lab

Regulatory Compliance & Quality Baseline

Feature / Parameter Medical Device Scope – ISO 18562OINDP & Aerosol Testing Scope
Accreditation StatusISO/IEC 17025:2018 Accredited (SWEDAC #10501)

Non-Accredited Analytical Service

 

Governing Standards ISO 18562-2, ISO 18562-3, ISO 18562-4 (ISO 18562:2024)Ph. Eur. 2.9.18, USP <601>/<1601>, ISO 27427, ISO 13320
Target ApplicationsEU MDR, FDA 510(k), Medical Respiratory DevicesFDA ANDA (BE), EMA Filings, R&D Formulation Screening
Quality FrameworkFull QMS with SWEDAC OversightInternal Quality System aligned with Pharmacopeias

Partner with the Nordic region’s Inhalation Experts

Whether you require ISO 17025 accredited biocompatibility testing for a medical device or tailored analytical support for an OINDP dossier, Emmace is your agile, uncomplicated CRO partner.

Contact us for more information

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