Only the highest quality raw materials are used in the manufacture of HyClone products. Each item has its own unique HyClone part number and controlled raw material specification. The specification document describes the product, the required grade or purity, the source, and the criteria for acceptance on incoming inspection. These specifications are provided to each respective supplier who must in turn certify that their product meets this standard for qualification.

HyClone’s suppliers are rated and approved through a supplier certification program, which evaluates each supplier for quality, availability, performance, and service. Where possible, HyClone qualifies secondary and back-up suppliers for each raw material or component. Customer-supplied or -specified raw materials can be incorporated into a product formulation and are given their own unique part numbers.

Since many of HyClone’s products are used in the biopharmaceutical industry, the standard procedure is to specify USP (United States Pharmacopoeia) or NF (National Formulary) grades where available. Multicompendial grades such as EP, JP, or others can also be specified where available at an added premium. For those raw materials that do not have pharmacopoeial monographs established, HyClone specifies chemicals that meet FCC (Food Chemical Codex), ACS (American Chemical Society), or other applicable grades. Any other chemicals must meet minimum requirements established by HyClone’s Quality Assurance Department.

Incoming raw materials are quarantined for QC inspection and acceptance. This inspection includes a physical examination of the product and its packaging and close scrutiny of the labeling and accompanying Certificates of Analysis to ensure that all specifications for grade, quality, and purity are met. Raw materials are sampled for identity testing (where practical).

In addition to high quality raw materials, HyClone uses Water for Injection quality water in the manufacture of liquid media and process liquids. All plastic product contact materials meet requirements for USP Biological Class VI testing and physicochemical testing.