Container Closure Integrity (CCI)
Whitehouse Laboratories’ Container Closure Integrity division is proud to offer numerous state- of-the-art options for assessing package system integrity, including all required instrumentation for deterministic test methods as outlined in proposed revisions to USP <1207>. Services range from routine testing to in-depth method development and validation. The CCIT Lab at Whitehouse provides expert-level services specifically tailored to the client and the package system.
Whitehouse Labs provides each client with an experienced and highly qualified team of chemists, engineers, and laboratory technicians that are solely dedicated to FDA regulated container and package testing. The entire team is well versed in all relevant regulatory test procedures under USP, EP, JP, CFR and ASTM methodologies. Many of the qualification tests are performed on a daily or weekly basis. In conjunction with, and under the direction of the Whitehouse Labs Quality Assurance department, staff members are kept up to date on both procedural and test method revisions through a strict schedule of training and re-training.
Packaging And Distribution
As an independent, third party laboratory, Whitehouse Laboratories is a trusted testing partner for packaging professionals for distribution testing, packaging materials qualification and product testing. Companies throughout the world trust Whitehouse Labs to meet and exceed their expectations; we partner with our clients to provide technical expertise and individualized service to complement each client’s unique needs.
Our ISTA Certified, ISO 17025 Accredited and fully cGMP Lab specializes in package testing for many industries.
Medical Device And Drug Delivery
We’re your one-stop source for medical device testing and validation — for products, materials and packaging. Our professional engineers and technicians provide reliable, quality-assured testing services and documentation throughout every step of the critically important testing and validation process.
Extractables/Leachables and Impurities
Extractable & Leachable evaluations have become increasingly more vital to successful product development and regulatory submissions. Recently, many E/L and chemical characterization guidelines, as well as standards, have been revised to better address patient safety considerations in the pharma/biotech and medical device industries, including USP standards and FDA guidance. These heightened requirements necessitate manufacturers to seek out experts who are aware of the industry trends and changes in the regulatory landscape for medical device evaluations and container qualification, as it pertains to final fill, intermediate storage, and manufacturing systems including Single Use Systems.
The stand-alone facility is adjacent to the Container Center of Excellence and is dedicated to basic USP 51, USP 61, and USP 62 testing including raw material through finished products. The facility meets the strict GMP requirements for FDA regulated, GMP testing to take place. All key pieces of equipment include state of the art incubators, ovens, and fume hoods.