Element is a recognized specialist partner in the provision of particle analysis for Particle Size Distribution (PSD) and particle counting. Our services help to ensure the quality and effectiveness of pharmaceuticals and medical devices.
The number and size of particles dispersed in a powder, fluid, or other material have a direct impact on the performance of medicinal products and medical devices.
In solid-dose or emulsion-based medicines, the particle size distribution and the number of particles can directly affect the efficacy of the product. Particle shape characterization is indispensable for flowability of powder, milling efficiency, dissolution of Active Pharmaceutical Ingredients (API), and rate of reaction. Within implantable medical devices and injectables, the particulate is unwanted and can impact the patient’s health if present in large numbers and large sizes.
Element provides expert analysis laboratory services for Particle Size Distribution (PSD) and particle counting following USP, EP, ASTM and ISO methods. Our particle size analysis techniques include:
- Particle Size Distribution (PSD) by light scattering
- Particle counting by light obscuration
- Scanning Electron Microscopy (SEM)
- Light Microscopy (LM)
- Microscopic image analysis
Working with Element
Element has extensive experience in particle characterization. We can develop and optimize characterization methods specific to your product, as well as support you with method transfer and validation. With an experienced eye on current regulatory guidance, our scientists are adept at helping you to meet the appropriate quality and regulatory standards.
As a Good Manufacturing Practice (cGMP) compliant laboratory, we recognize the importance of putting product quality first and maintaining production excellence at each and every step in the pharmaceutical manufacturing process.
To learn more about Particle Size Distribution (PSD), or for more information about our particle size analysis, contact us today.
Test Protocol for Medical Devices
A protocol and plan will mitigate your risk, prevent confusion, set clear expectations, and preserve the necessary information for future reference and use.
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
Find out how Element's chemistry teams work with our customers to identify the contents, composition and quality of materials they develop and manufacture.
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.