Contamination Control and Source Determination Investigations 

Foreign particulate matter investigations play a crucial role in maintaining the quality and control of the pharmaceutical manufacturing process. These investigations help identify the types of particles present and assess their potential impact on patients receiving treatment.

Contamination Control and Source Determination Investigations at Gateway Analytical involve identifying and tracing the origins of unwanted particulates in pharmaceutical products. This meticulous process ensures product integrity by pinpointing the source of contamination, enabling targeted measures to prevent future occurrences and uphold the highest standards of patient safety and product quality.

A Clear Vision in Contaminant Control

Identifying the particulate matter is only the first step. A thorough investigation must also determine the potential source of the particulate matter. This is necessary to prevent future contamination of the manufacturing process. Failure to investigate the origin of particulate matter displays a lack of control over the manufacturing process, which could lead to regulatory scrutiny and intervention.

Gateway Analytical - Analysis Solutions

Gateway to Clarity: Pinpointing Contaminants

 Our source determination investigations bring clarity to the complexity of particulate contamination. By combining advanced technology with in-depth expertise, we offer unparalleled insights.

Ensuring Efficacy: Expert Contamination Investigations

Gateway Analytical specializes in forensic trace evidence investigations and provides a step-by-step multi-analytical approach to identifying foreign particulate contaminants and their sources. Since 2010, companies have relied on Gateway Analytical to help them eliminate particulate matter from their pharmaceutical manufacturing process.

Early-Phase Development

Comprehensive packages designed to navigate clinical & regulatory complexities of parenteral product-package and container-closure development, from concept to market readiness.

Container Closure
Integrity Testing

Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.

Particulate
Analysis

Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.

Medical Device
Analysis

Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.

Extractables
& Leachables

Studies aimed at identifying potentially harmful compounds in manufacturing components and final containers to ensure the safety and efficacy of pharmaceutical products.

At Gateway Analytical, our contamination control and source determination investigations go beyond standard protocols. We delve deep into the world of foreign particulates, offering unmatched forensic expertise