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: