Particle Size Distribution (PSD) Testing and Analysis
Need to ensure your pharmaceutical products and medical devices meet strict particle size requirements? Our comprehensive Particle Size Distribution (PSD) testing and analysis services help maintain product efficacy, ensure patient safety, and meet regulatory compliance. We provide expert testing, method development, and GMP-compliant analysis from development through manufacturing—keeping your products performing at their best.
What is particle size distribution (PSD) testing and analysis at Element?
PSD testing measures the number, size, and distribution of particles in pharmaceuticals and medical devices - critical factors that directly impact product performance and patient safety. At Element, we provide comprehensive particle analysis services using multiple advanced techniques, helping you ensure product quality from development through manufacturing.
What can Element offer you for Particle Size Distribution (PSD) Testing and Analysis?
Materials we test:
Materials we test:
We analyze particle characteristics across your entire product range - from raw materials and APIs to finished medications and medical devices. Our expertise covers solid-dose formulations, emulsion-based medicines, injectables, and implantable devices.
Key tests offered
Key tests offered
Our comprehensive testing portfolio includes particle size measurement, particle counting, shape characterization, and distribution analysis. These tests are critical for ensuring product quality, performance, and patient safety, particularly for implantable devices and injectables where incorrect particle sizes can cause serious health complications.
Methods and solutions offered
Methods and solutions offered
We develop and optimize product-specific characterization methods, support method transfer and validation, and ensure compliance with current regulatory requirements. Our GMP-compliant processes help you maintain consistent quality throughout your manufacturing process.
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
- Light Microscopy (LM)
- Microscopic image analysis
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Method transfer support
Method transfer support
We streamline your testing process by providing comprehensive method transfer and validation support. Our scientists work with you to ensure smooth transitions and consistent results across your testing requirements, helping maintain quality standards throughout your product lifecycle.
Standards we test to and products we test
Pharmaceutical Testing Standards:
- United States Pharmacopeia (USP) particle testing methods
- European Pharmacopoeia (EP) standards
- American Society for Testing and Materials (ASTM) methods
- International Organization for Standardization (ISO) requirements
- Current Good Manufacturing Practice (cGMP) regulations
Pharmaceutical Products:
- Solid-dose medicines
- Emulsion-based pharmaceuticals
- Injectable medications
- Active pharmaceutical ingredients
Medical Devices:
- Implantable devices
- Injectable devices
Your Challenges, Our Solutions
Product Efficacy Risk
Patient Safety Concerns
Manufacturing Process Control
Regulatory Compliance Made Simple
Why Choose Element
Complete Testing Solution
Pharmaceutical Testing Excellence
Custom Method Development
Quality Focused Approach
Frequently asked questions
How does particle size affect pharmaceutical products?
Particle size and distribution directly impact medicine efficacy, affecting powder flowability, milling efficiency, API dissolution, and reaction rates. For implantable devices and injectables, particle control is crucial for patient safety.
What makes particle shape characterization important?
Particle shape characterization is crucial for determining powder flowability, milling efficiency, dissolution of Active Pharmaceutical Ingredients (API), and rate of reaction - all critical factors in pharmaceutical manufacturing quality.
Can Element help with method development?
Yes, we develop and optimize characterization methods specific to your product. Our scientists combine regulatory expertise with practical experience to create testing methods that meet both your product requirements and regulatory standards.
Explore our global network of labs and find your nearest location
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