Diagnostics with Sanner’s CDMO Services
- Highly Precise and Robust Diagnostics Production
- Precision Injection Molding for Diagnostic Applications
- Blood Glucose Measurement
- Diagnostic Device Quality
From complex modular diagnostic reagent cartridges to clinically sensitive in-vitro lateral flow tests and packaging, Sanner develops diagnostic solutions for CDMO customers that are scalable to production scale. Sanner can produce point of care rapid tests for a wide range of test applications including cardiac markers, antigens of Covid-19 or Influenza, as well as Urine, HIV or pregnancy tests. We provide individual moisture-regulating final packaging options with integrated desiccant components for products requiring specific climatic conditions in order to support their functionality.
In addition, we produce laboratory diagnostic components for HbA1c blood tests, modular cassette systems optimized for laboratory analysis instruments, as well as a range of disposable consumables for laboratory diagnostic applications. When designing and developing a highly specific diagnostic device Sanner engineering can create scalable concepts that align with material compatibility and regulatory requirements.
Precision injection molding capabilities are critical to producing reliable, high-quality diagnostic products with low variation at high unit volumes. Sanner is an established leader in injection molding technology with decades of experience in applying it to diagnostic applications. For complex diagnostic devices, such as multi-chamber lateral flow assays, Sanner can precisely mold housings using thin wall injection molding (<0.5mm) while avoiding component deformation. By controlling the precision of the molded components, Sanner can optimize product assembly and the robustness of the device. We take a holistic approach to developing our injection molding process and optimize microfluidic controls, improved gating, and controlled cooling to produce more consistent and higher-quality components. Our use of advanced in-process sensor and camera systems can measure surface evenness, improve tolerances for fit, and eliminate potential contamination. We adhere to raw material selection optimization strategies and design user-friendly housings for ease of patient handling and use. At Sanner, our services produce diagnostic devices with ideally matched materials and connecting parts to achieve a reliable test result, crucial to protecting patient health.
Sanner is the number one supplier in Asia of test strip packaging for blood glucose monitoring. Sanner supplies in-vitro diagnostics customers worldwide with tubes and desiccant closures for the packaging of test strips for blood glucose measurement, including :
- User-friendly flip-top packaging
- White and black plastic tubes of different sizes
- Matching desiccant caps
The requirements for diagnostic devices and rapid tests are highly specific as each patient's health can depend on a test result. Sanner develops and manufactures specific diagnostic products to the highest standards for its customers, minimizing risk throughout the entire commercialization process. Critical diagnostic tests require manufacturing continuity, regulatory compliance and clinical test reliability. During development, component quality is controlled with extensive monitoring, and future assembly efficiency is already thoroughly considered.
Diagnostic components and disposables are made with 100% traceability through integrated ME systems and can be made in available clean rooms. Sanner manufactures to GMP standards, while meeting U.S. FDA and European regulatory requirements. Sanner’s facilities have earned both ISO 13485 and ISO 15378 certifications and is all part of our dedication to delivering high quality diagnostic products through state-of-the-art facilities and quality management systems (QMS) to our CDMO customers.
Sanner has been designing, developing, and manufacturing diagnostic applications for decades. Our CDMO offering fully supports global customer needs for custom diagnostic manufacturing in our network of high-quality European and Asian sites. Our industry leading understanding of injection molding science combined with decades of regulatory experience in supporting filings, DMFs and other regulatory requirements means Sanner is uniquely positioned to support CDMO customers with complete diagnostic device services.