Particulate Control Strategies. Solutions.
20+ Years Creating Valuable Particulate Control Strategies for Fortune 500 Pharma & Medical Device Companies!
Gateway Analytical delivers comprehensive particulate control solutions, combining rapid, high-accuracy identification with proactive risk management for pharmaceutical and biotechnology products. Our FDA-registered, cGMP-compliant lab supports every stage of development, ensuring regulatory compliance, product integrity, and market success through advanced analytical expertise and strategic contamination prevention.
Comprehensive Particulate Analysis Services
We offer a full suite of analytical services tailored to the pharmaceutical and medical device industries, including:
Regulatory Testing for Particulate Matter
USP <788> Particulate Matter in Injections – Quantification of subvisible particulates in injectables.
USP <790> Visible Particulates in Injections – Compliance support for visual inspection programs.
USP <1790> Visual Inspection for Injectable Products – Risk-based strategies for managing visible particles.
USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections – Alternative methods for protein-based formulations.
USP <789> Particulate Matter in Ophthalmic Solutions – Ensuring clear and contaminant-free ophthalmic products.
JP 6.07 & Ph. Eur. 2.9.19 – International standards for particulate analysis in injectable formulations.
Specialized Particulate Testing and Investigations
Specialized Particulate Testing and Investigations
Identification Testing for Visible Particle Defects – Determining the composition and origin of contaminants.
Difficult-to-Inspect Parenteral (DIP) Products – Advanced secondary screening for complex formulations.
Contamination Control & Source Determination – Investigating and mitigating foreign particulates.
Rinse Studies – Evaluating particulate burden in primary containers, closures, and single-use systems.
Forensic Particulate Analysis – Comprehensive multi-analytical approaches for contamination root cause analysis.
Advanced Techniques for Precision Analysis
Our state-of-the-art laboratory utilizes cutting-edge methodologies to deliver accurate, reliable, and regulatory-compliant results:
Light Obscuration & Micro-Flow Imaging (MFI) – For subvisible particle counting and characterization.
Light Microscopy & Scanning Electron Microscopy (SEM) – For detailed visualization and morphology assessment.
Fourier Transform Infrared Spectroscopy (FTIR) & Raman Spectroscopy – Chemical identification of unknown particulates.
Energy-Dispersive X-ray Spectroscopy (EDS) – Elemental composition analysis for material characterization.
High-Performance Liquid Chromatography (HPLC) & Mass Spectrometry (MS) – For precise chemical profiling.
Why Choose Gateway Analytical?
Unmatched Regulatory Expertise – Gateway Analytical and our expert team ensure full compliance with USP, EP, JP, and FDA standards.
Fastest Turnaround Times – Our team delivers precise, efficient testing to keep your products on track.
Tailored Analytical Strategies – We design customized solutions to meet your unique regulatory and product requirements.
Proven Industry Leadership – Backed by decades of experience, our team is trusted by leading pharmaceutical and biotechnology innovators.
Covering every stage of the drug development journey with our state-of-the-art, FDA-inspected, cGMP-compliant facilities designed to minimize bottlenecks and maximize success.