Hanford Support Services - Additional Considerations

Hanford has established an excellent reputation with the FDA, consistently outperforming other pharmaceutical finishers in annual audits. Management believes the number of 483s issued to the Company is consistently much lower than most of our competitors and attributes this success to Hanford’s modern, well equipped facilities and highly-trained employees.

Laboratories for Product Development and Quality Control Testing:

Hanford maintains fully equipped and staffed analytical testing laboratories capable of evaluating all 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 any 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 full product stability testing capabilities, including temperature and humidity controlled chamber 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 the microbiological environmental monitoring required to support aseptic processing lines. 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 two Steris VHP-1000 vapor phase hydrogen peroxide decontamination systems to ensure that the isolators are decontaminated to current FDA and USP requirements.