In addition to production in the single-use disposable manufacturing suite, HyClone’s liquid media, reagents, and process liquids are also manufactured in two additional filtration suites: 1) the large volume production suite where product is filled into HyClone’s disposable BioProcess Containers, and 2) the small volume suite where product is filled into rigid PETE or PETG bottles.

The liquid media filling areas maintain separate HEPA air handling systems. Each filling suite is environmentally monitored by Quality Control to ensure that the manufacturing areas remain within specified ranges.

Formulation, mixing, and filtration of large volume liquids take place in a Class 100,000 clean room. The Large Volume Liquid Media Core features stainless steel tanks capable of producing lot sizes up to 10,000 L. Sterilizing 0.2 or 0.1 micron filters, stainless steel manifolds, and connections from gamma-irradiated BioProcess Containers to those manifolds are sterilized using steam-in-place (SIP). No aseptic connections are made, resulting in a true, closed system filling environment.

Small volume sterile liquids are filled utilizing a “fill-by-weight” system located in a Class 1000-rated production suite in a Class 100 hood. Equilibrated solutions are sterile filtered into irradiated bottles using autoclaved filling heads and equipment.

Production of Liquids
HyClone utilizes state-of-the-art filtration and aseptic fill technologies to manufacture liquid media, buffers, and reagents. All facilities and processes are validated to ensure that products meet not only HyClone’s exacting quality standards, but also cGMP and ISO 9001:2000 guidelines.

Standard or custom liquid formulations are available in lot sizes up to 10,000 L. Depending upon lot size and product application, products can be manufactured in HyClone’s traditional production suite that utilizes Clean-in-Place (CIP) and Steam-in-Place (SIP), or in the HyNetics suite using disposible surfaces. Water for Injection (WFI) quality water is available for manufacture of liquid products.

Liquid products are sterile-filtered using validated microbe-retentive filters. Filter integrity tests are performed pre- and post-filtration for traditional filling systems, and post filtration for single-use capsule filters.