HyClone recognizes that many industrial and research customers have proprietary media formulations. In addition to standard media products, HyClone offers an extensive customization program whereby proprietary formulation is manufactured and packaged in a delivery system to meet customer applications. Custom cell culture media, buffers and reagents can be manufactured in both liquid and powdered form. Liquids can be packaged for convenience in bottles and HyClone’s BioProcess Containers™ (BPCs).

By understanding that many cell culture applications are unique, HyClone has become a leader in formulation and packaging customization.

As a leading BioProcess Container manufacturer, HyClone has the ability to produce single-use, disposable customized delivery systems ranging in size from 50 mL to 1,000 L. (Standard BPC configurations available for customer liquid fills are shown on page 68.) Standard PETE/PETG bottles are also available in 100 mL, 250 mL, 500 mL, and 1000 mL. Custom liquid production lot sizes range from 50 to 10,000 L, while dry powdered media and buffers are available in lot sizes from 1 to 6,500 kg.

To ensure that requirements for custom products are met, HyClone has developed an ISO 9001:2000-compliant Contract Review Procedure. This procedure was implemented to facilitate the development of product specifications that are mutually agreedupon by HyClone and the customer.

The process begins with the completion of a Product Brief that defines a product’s particular requirements.Typical requirements defined in the Product Brief include:

• product name and description
• packaging requirements and delivery systems
• product formulation
• release criteria and Certificate of Analysis reporting
• storage and shipping conditions
• expiry information

Once the Product Brief is submitted to HyClone, a qualified design development team conducts an extensive review of the specified requirements to ensure that the product requirements can be met. HyClone’s staff is trained to assess each custom request to confirm that all product requirements are adequately understood and defined.

Upon acceptance of the Product Brief by the HyClone Development Team—which consists of delegates from Product Management, Manufacturing, R&PD, Quality Control, and Engineering—the requirements are translated into a Product Specification which is assigned its own unique part number. The specification is then presented to the customer for review and approval.

Once approved by the customer and returned to HyClone, the Product Specification undergoes final approval in HyClone’s Document Control System. Upon receipt of a purchase order, the product is ready for production. The flow diagram below represents the custom product development process at HyClone.

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