Quality Control and Product Release Testing
HyClone takes pride in providing the highest quality products and services. In order to maintain high quality standards, all of HyClone’s products as well as raw material components must pass strict Quality Control testing. Extensive testing confirms the appropriate level of quality.

HyClone’s quality policy directive states:

“We manufacture products of the highest quality to assure conformance to customer requirements and appropriate regulatory standards.”

HyClone’s product specifications define and stipulate the finished part inspection necessary for acceptability and release of each lot of finished product.

In custom product applications, the finished product release tests and acceptability levels are jointly determined by HyClone and the customer. For standard products developed exclusively by HyClone, appropriate release tests and specifications are established.

Each product specification includes validated release criteria and in-process testing. Only those products that conform to these stringent requirements are released for sale. A detailed Certificate of Analysis (COA) that includes the product attributes, specifications, and actual test results is provided with each lot manufactured.

The release criteria listed below are examples of testing that is performed to ensure quality liquid and powdered products.

In order to meet customers’ unique testing requirements, additional quality control testing is available on a custom basis.

Product Specifications
HyClone is ISO 9001:2000 certified and follows cGMP guidelines. Accordingly, consistency, traceability, and quality are basic elements of operation. At HyClone, it is crucial to document thorough definition of each product and to establish rigid procedures for product manufacturing, testing, and handling. Business operations at HyClone are coordinated through an integrated ERP computer system that drives planning, manufacture, release, and shipment of every product. Under this system, HyClone establishes unique part numbers and specifications for all raw materials and components, process intermediates, and finished products.

Each part number has a corresponding specification document. Defined within the specification are the product name, labeling information, packaging, formulation, reference procedures for manufacture or testing, release testing and criteria for acceptance, storage, and shipping conditions, expiry information, and all information to be reported on the COA.