In addition to the primary facilities in Logan, Utah, HyClone operates a cGMP manufacturing facility in Cramlington, UK. This facility produces liquid media and process liquids for the biotechnology industry. Products manufactured in Cramlington include basal cell culture media, serum-containing media, serum-free media, process buffers and reagents, and WFI quality water.

Sterile-filtered liquids packaged in HyClone’s BioProcess Containers™ (BPCs) can be manufactured at the Cramlington facility with lot sizes up to 5,000 L. A facility expansion completed in the first quarter of 2004 has increased maximum lots sizes to 10,000 L. Small-volume liquids packaged in 1,000 mL bottles are also manufactured at the Cramlington facility in lot sizes up to 1,000 L. Small-volume liquids are filtered in a Class 100 zone in the Class 1000 suite.

Each of the manufacturing and filtration suites is tested and certified for acceptable levels of particulate every six to twelve months, with routine environmental monitoring to confirm certification.

The expansions to the Cramlington manufacturing facility have both increased production capacity and provided segregated manufacturing areas that are free from animal derived components. Included in the next phase of the facility upgrade will be the addition of a HyNetics™ single-use product contact manufacturing module.

Phase II expansions will also include a dry powdered media facility featuring the same high-speed micronization system used in Logan.These expansions enable HyClone to better serve the European community, greatly increase HyClone’s global manufacturing capacity, and provide manufacturing backup to HyClone’s operations in the United States.