BPOG E&L

At Gateway Analytical, our team expertly applies a range of advanced, standardized techniques in Extractables and Leachables (E&L) testing. We’re dedicated to accurately identifying and measuring E&L compounds, ensuring precision and reliability in every analysis.

E&L Study: BPOG E&L

BPOG, or the BioPhorum Operations Group, is an industry consortium that provides guidance and best practices for the biopharmaceutical industry. BPOG has developed a standardized protocol for E&L testing of single-use bioprocess containers, which includes a range of analytical techniques to identify and quantify extractables and leachables. By performing BPOG E&L testing, manufacturers can ensure the safety and quality of their drug products and comply with regulatory requirements.

Gateway Analytical - Analysis Solutions

Choose Gateway Analytical for your BPOG E&L testing needs. Let's safeguard the integrity of your biopharmaceutical products together.

Gateway Analytical - Analysis Solutions

E&L Study: BPOG E&L

BPOG E&L testing refers to testing extractables and leachables in single-use bioprocess containers used in the biopharmaceutical industry. Extractables are chemical compounds that can be extracted from the container material under certain conditions, such as high temperature or exposure to solvents. Leachables, on the other hand, are chemical compounds that can migrate from the container material into the drug product during use. These compounds can affect the drug product’s safety, efficacy, and stability.

Extractables
& Leachables

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

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.

Early-Phase Development

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