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The Importance of Condensate Volume Determination According to ISO 18562-4 – Emmace Insight

Emmace Insight: The Importance of Condensate Volume Determination According to ISO 18562-4 Background For medical device manufacturers, ensuring the safety of a product is paramount. When it comes to devices that interact with a patient’s respiratory system—the breathing gas pathway—specific biocompatibility standards must be fulfilled. The ISO 18562 series address the biological evaluation of these

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Mårten Svensson ​Co-authors Scientific Publication​

Mårten Svensson Co-authors Scientific Publication Emmace Consulting is proud to announce that Mårten Svensson has co-authored a new and significant scientific article. Titled “Multi-Participant Blinded Investigation into Internal Losses of Medication in Commercially Available Mixing Inlets: Testing Different Orally Inhaled Product Classes Following Pharmacopeial Methods,” the article has been published in the J Aerosol Med.

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Emmace Achieves Accreditation for ISO 18562-4 Condensate Volume Determination

Emmace Achieves Accreditation for ISO 18562-4 Condensate Volume Determination We are pleased to announce that we have received accreditation from SWEDAC for our internally developed method for determining condensate volume of breathing gas pathways, adhering to ISO 18562-4. This significant achievement underscores Emmace’s dedication to providing cutting-edge biocompatibility testing of medical devices. This accreditation complements

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​Advancing Inhalation Drug Development: iBCS Framework in Focus

Advancing Inhalation Drug Development: iBCS Framework in Focus A new publication co-authored by Per Bäckman, Senior Adviser at Emmace, marks the fourth paper in a series on the Inhalation Biopharmaceutics Classification System (iBCS). Published in Molecular Pharmaceutics, the study explores how iBCS can be applied throughout drug discovery, development, and regulatory evaluation for orally inhaled

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New Insights into Drug Distribution and Coating in Inhalation Powders​

New Insights into Drug Distribution and Coating in Inhalation Powders A recent study by researchers at RISE and Emmace Consulting (Adj Prof Kyrre Thalberg), published in Surface and Interface Analysis, explores the molecular 3D distribution of budesonide and magnesium stearate (Mg-stearate) in dry powder inhalation formulations. Using advanced ToF-SIMS imaging and XPS analysis, the study reveals

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Emmace submit a unique and advanced method for ISO accreditation

Emmace Consulting submit a unique and advanced method for ISO accreditation We’re thrilled to announce that our in-house developed method for condensate testing, according to the standard ISO 18562-4:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate, has been submitted for ISO 17025 accreditation. Our innovative approach

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Leadership Changes to Drive Growth and Innovation

Emmace Announces Leadership Changes to Drive Growth and Innovation Lund, April 15th, 2024 — Emmace Consulting AB, a leading player in the pharmaceutical and medical device sectors, is pleased to announce strategic leadership transitions aimed at strengthening the competitive edge and fueling continued growth. Dr. Anna Holmberg Appointed as New CEO Dr. Anna Holmberg, who has

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