Laser-based headspace analysis technology has repeatedly proven to be a key part of comprehensive USP <1207> CCI programs across a product’s lifecycle for both sterile and gas sensitive products, and Lighthouse Instruments has remained at the forefront of innovating these applications
CLIFTON, N.J. (PRWEB) June 23, 2021
CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, is pleased to announce that it has completed the installation and cGMP qualification process for its suite of laser-based headspace analysis systems in support of the USP〈1207〉Container Integrity Testing service platform. The supplier, Lighthouse Instruments, is the leader in nondestructive laser-based headspace analysis and its suite of instruments include the Headspace Analyzers (for Oxygen, Carbon Dioxide, and Moisture/Pressure) and Container Closure Integrity Test Vessel, enabling gas ingress (leak) testing and the generation of robust statistical CCI data.
Commented Chief Scientific Officer Brandon Zurawlow, “Laser-based headspace analysis technology has repeatedly proven to be a key part of comprehensive USP〈1207〉CCI programs across a product’s lifecycle for both sterile and gas sensitive products, and Lighthouse Instruments has remained at the forefront of innovating these applications. The work we perform for clients in the laboratory using Lighthouse instrumentation provides critical insight into package development and validation, manufacturing, distribution, and stability.”
Dr. Derek Duncan, Director Product Line at Lighthouse, “We are very pleased with our partnership with CS Analytical, enabling further implementation of headspace gas ingress CCI testing methods. By generating robust CCI data in product life cycle activities, customers will be in position to meet the evolving requirements from the regulators in the area of CCI.”
The Lighthouse Technology will be a cornerstone of the CS Analytical Container Closure Integrity testing offering and further solidifies CS Analytical as service provider that is at the cutting edge of CCI method development and validation programs that span multiple package types across the complete package lifecycle. USP〈1207〉Container Closure Integrity Testing is a critical regulatory requirement for container and package systems at all phases of the product lifecycle. The ability to provide all USP〈1207〉test methodologies, in conjunction with a host of other complimentary testing services specific to package systems, enables the CS Analytical Team to meet the client demand in an effective and routine manner.
About CS Analytical Laboratory
The world’s only cGMP, FDA-registered contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, the CS Analytical Team includes world-leading experts and thought-leaders on FDA and EU regulatory expectations and USP and EP primary package testing requirements inclusive of container closure integrity (CCI) testing (CCIT). Test services include CCI method development, validation, and analysis, USP/EP/JP physical and physicochemical testing, and Comprehensive and Complementary services for all common or unique primary packaging components and systems inclusive of glass, plastic, elastomeric, and more. CS Analytical is the single source to ensure a regulated industry product-package system meets strict, complex, and ever-changing regulatory requirements.
About Lighthouse Instruments
LIGHTHOUSE Instruments is the leading provider and manufacturer of headspace analysis platforms and measurement services, offering solutions for Container Closure Integrity Testing, headspace Oxygen Monitoring, Moisture Determination and Microbial Contamination inspection of media vials. As a science-based company, Lighthouse provides clients with equipment, knowledge, and expertise gained from analyzing and inspecting millions of finished drug samples from pharmaceutical facilities around the world.