Operating a cGMP, FDA-registered Container and Package Qualification laboratory requires a number of unique programs, systems and instruments to ensure client demand and expectations will be met. This is especially critical when it comes to USP <1207> Container Closure Integrity Testing as the need for instrument change parts, method development and instrument customization guidance, and positive and negative controls are key factors in ensuring a successful CCI test program. CS Analytical works with a variety of key partners on a routine basis to ensure offered services and programs remain on the cutting edge of technological and regulatory advancements, which our clients have come to expect.

Due the increasing complexity of USP testing, examples of which include the revision of General Chapter <661.1> and <661.2>, the expanded need for specialized services such as extractable and leachable testing, and the expansion of methods in <671>, successful strategy development and implementation requires a team of subject matter experts to comprehensively evaluate a package system’s specific requirements. CS Analytical represents the one source for all container and package qualification testing needs, aligning resources through internal and external capabilities for client success.

Our critical partners for success include:

Packaging Technologies & Inspection Inc.  www.ptiusa.com

PTI is the leading manufacturer of non-destructive package inspection technologies for the pharmaceutical, medical device and food industries.

Lighthouse Instruments    www.lighthouseinstruments.com

Lighthouse is the leading global provider of optical-based, non-destructive headspace analysis systems and measurement services that lower the cost and ensure the quality of parenteral products.

Leak Detection Associates (a PTI Company)  www.heliumleak.com

For more than twenty-five years, Leak Detection Associates has served as the world’s premier manufacturer of custom-built helium leak detection solutions for pharmaceutical, biotechnology, medical device and food packaging clients.

Lenox Laser   www.lenoxlaser.com

Lenox Laser, provides customized laser drilling services of calibrated leaks for pharmaceutical packages that serve as standards for container closure integrity testing method development and validation as part of a USP <1207> testing program

Improved Pharma  https://improvedpharma.com/

Improved Pharma is a research and information company dedicated to improving pharmaceutical methods, formulations, and processes. Services include solid-state form studies, formulation design, synchrotron techniques, analytical testing, and expert consulting for the development and defense of intellectual property matters. The company was founded in 2006 by Stephen and Sarah Byrn, who also founded SSCI.

Chemical Microscopy  https://chemicalmicroscopy.com/

Chemical Microscopy is a full-service microscopy and microanalytical materials analysis laboratory specializing in identification and characterization of unknown foreign particulate matter, raw materials analysis, packaging materials, glass enclosures and ceramics, and polymers.  We provide confidential client specific problem-solving in a timely manner.