Residual Seal Force Testing Services

At Gateway Analytical, we provide advanced residual seal force testing; a non-destructive test method used in the pharmaceutical and biotechnology industries to evaluate the effectiveness of container closure systems in preventing the ingress of microorganisms or other harmful substances. It measures the force required to reopen a container after it has been sealed, indicating the seal’s strength. 

The test involves placing a sealed container into a testing device, which applies a controlled force to open the container. The pressure required to open the container is measured and recorded. This force measurement is then compared to a predetermined value to determine whether the seal is strong enough to meet the required standards. 

CCIT Study: Residual Seal Force (RSF)

Our RSF testing goes beyond standard quality checks. It is a comprehensive assessment of your container’s ability to maintain sterility and protect against microorganism ingress or other harmful substances. The residual seal force test is an important quality control tool that can help ensure the safety and efficacy of pharmaceutical and biotech products. It is commonly used in the production of sterile parenteral products, such as injectables and infusions, as well as in the manufacture of medical devices.

Gateway Analytical - Analysis Solutions

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.

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.