Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.
The FMS-Moisture/Pressure non-destructive headspace moisture and pressure analyzer is a compact benchtop instrument that utilizes a patented laser absorption technique developed with funding from the FDA. This rapid and versatile technology addresses a wide range of applications that spans the full product life cycle.
The FMS-Carbon Dioxide analyzer measures the headspace carbon dioxide levels of sterile pharmaceutical containers non-destructively, in development, manufacturing and QC. This system can be used for CCI testing of frozen product in storage or transport studies.
The Integra uses the same proven three spinning roller sealing head design as the standard PW Westcapper®. Now, a servo driven actuator will bring the sealing head to the vial and utilize a load cell to accurately provide proper sealing pressure. This functionality provides a quality seal despite variations in vial height.
Re-designed from the ground up, the ALL NEW second generation Genesis Residual Seal Force Tester evaluates seal tightness of a sealed parenteral vial by measuring the Residual Seal Force in the stopper/seal combination created as a result of the sealing process.
The CCI Test Vessel provides a simple means of preparing samples for container closure integrity testing (CCIT) using the highly-sensitive and non-destructive laser-based headspace analysis technology. When combined with a LIGHTHOUSE FMS Headspace Gas Analyzer, the CCI Test Vessel offers a robust solution for container integrity tests on a wide range of container types and packaging conditions.
LIGHTHOUSE offers both equipment and measurement services for container closure integrity testing. LIGHTHOUSE supports customers who are preparing to implement deterministic CCI testing methods. Services for CCI Testing include scientific feasiblity studies, test method development, and equipment lease for on-site testing activities
The FMS-Water Activity Analyzer is a non-destructive gas analyzer for making water activity measurements of solid dosage drug product samples.The non-destructive nature of the measurement method enables a broad range of moisture activity applications and offers significant advantages over traditional techniques.