Hanford has established an excellent reputation with the FDA and consistently performs successfully in regulatory inspections.
Hanford maintains fully equipped and staffed analytical testing laboratories capable of evaluating APIs, excipients, components (vials, syringes, stoppers, packaging materials, etc.) and final products to ensure they meet all established quality specifications. The company is fully capable of conducting quality control analysis and like all Hanford operational departments, the laboratories have undergone frequent FDA inspections and customer audits to ensure their compliance with regulatory and industry requirements.
The Company’s chemistry laboratories are fully-equipped with gas and high performance liquid chromatography systems, as well as particle size determination systems. Hanford is also equipped with product stability testing capabilities, including temperature and humidity controlled chambers that can be used for the support of both marketed product and products under development.
The Company also maintains a microbiology laboratory to conduct testing on excipients and APIs. In addition to this analytical testing role, the microbiology laboratory also conducts environmental monitoring required to support aseptic processing. The Company was among the first to implement Isolator Technology for critical sterility testing, which is performed on both incoming sterile APIs and finished product. To ensure maximum reliability in sterility testing, Hanford installed its first isolators in 1993. In 2006, the Company updated to a newer generation of Isolator equipment. Hanford has Steris VHP-1000 vapor phase hydrogen peroxide decontamination systems to ensure that the isolators are compliant current FDA and USP requirements.