Analytical Services
Emmace is a world-leading inhalation analytics test lab (CRO) with highly skilled laboratory personnel and the best advisors in the inhalation world.
World-leading Inhalation Analytics Test Lab
We offer comprehensive analytical testing of inhalers, medical devices, nasal products and nebulizers. We have wide expertise and experience in inhalation product development, inhalation analytics and specialized aerosol measurements.
The world class advisors on inhalation science at Emmace help you solve the challenges and provide you with various possibilities in the inhalation product development process. Altogether our skilled personnel have more than 200 years of experience in inhalation product development.
Our clients include a wide variety of companies, from Big Pharma and Big Generic to the passionate start-up innovator. We are agile and customer centered – when necessary we can change the scope and test program during an ongoing study, according to the client’s wishes. Every study is tailor-made to suit the client’s needs.
Inhalation & Aerosol analytics
We are experts in specialized aerosol measurements of inhalation drug products including DPIs (dry powder inhalers), MDIs (metered-dose inhalers), nasal products and nebulizers. Our laboratory instrumentation and facilities are highly adapted for this purpose. In addition, we also offer measurements using unique instrumentation that are located at academic laboratories or provided by our partners.
Our laboratory is accredited by SWEDAC (national accreditation body for Sweden) according to ISO 17025:2017, which is the highest ISO standard for test laboratories.
Our analytical services portfolio includes:
- Cascade Impactor testing/Determination of aerodynamic particle size (APSD) and fine particle dose (FPD) with
- Next generation impactor (NGI)
- Multi stage liquid impactor (MSLI)
- Andersen cascade impactor (ACI)
- Delivered dose uniformity, Emitted dose uniformity and DUSA
- Nasal device testing
- Nebulizer testing
- Laser diffraction testing of aerosol
- Plume geometry/Spray pattern/Plume front velocity
- Dissolution testing of the lung dose
- Prediction of lung dose – in vitro in vivo correlation
- Solubility and chemical quantification of APIs/drugs
- Other analytical techniques and instrumentation
Method development & validation
Development and validation of HPLC methods are at the core of our lab services with a lab staff specialized in the field. Method development and validation is available both as a separate service and as part of formulation development projects.
Our analytical services portfolio includes:
- Method development:
- research and development phase methods
- methods according to European Pharmacopoeia
- Method validation and transfer for various analytical techniques with full documentation can be provided.
- Method transfer to receiving laboratory
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
