Agno Pharma’s Particle Sciences, Inc. Achieves ISO 13485:2016 Certification
Agno Pharma recently announced its subsidiary, Particle Sciences, Inc., has earned ISO 13485:2016 certification from National Quality Assurance, U.S.A. (NQA). This achievement underscores Particle Sciences’ dedication to maintaining the highest quality standards in the design, development, and manufacturing of medical device components.
Located in Bethlehem, PA, Particle Sciences provides contract manufacturing and engineering support for medical devices, including implants and pre-filled components, serving the biotech and pharmaceutical industries. ISO 13485:2016 is an internationally recognized standard for quality management systems in the medical device sector. This certification demonstrates Particle Sciences’ commitment to continuous improvement, product safety, and adherence to regulatory and customer requirements.
“Particle Sciences, Inc. is proud to announce that as of April 1, 2025, our Bethlehem facility has received ISO 13485 certification. The company underwent a thorough audit by NQA, with all action items completed by March 2025. This certification enables us to better support our clients in the production of medical devices and combination products while ensuring compliance with the highest manufacturing and release standards,” said Chris Dehart, Director of Quality. “With this new certification, we reaffirm our commitment to delivering high-quality products that meet or exceed client expectations and timelines.”
For more information, please visit www.agnopharma.com or contact info@agnopharma.com.
Agno Pharma is a global Contract Development and Manufacturing Organization (CDMO) specializing in regulatory starting materials (RSMs), intermediates, active pharmaceutical ingredients (APIs), highly potent APIs, sterile APIs, and sterile drug product formulations. Founded in 2004, Agno offers GMP-compliant manufacturing facilities and has expertise in sterile suspension injectables and complex injectables. Agno supports clients throughout the drug development and commercialization process globally.
Particle Sciences, based in Bethlehem, PA, is a full-service CDMO that specializes in the formulation, development, and production of complex drug and medical device products. Founded in 1991, Particle Sciences offers integrated solutions and a comprehensive range of services, including analytical development & validation and manufacturing. The company is renowned for its expertise in handling poorly soluble and highly potent compounds in both sterile and non-sterile dosage forms.
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