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 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
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
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