Sartorius Stedim

Celsius® – Biopharma Freeze Thaw System

In the world of biopharmaceutical processing, five liter containers of raw materials can be worth hundreds of thousands of dollars and must be controlled and protected at every step in the manufacturing process. SartoriusOften these materials need to be frozen and thawed in a very controlled way and be well-protected during transport and storage. Insight helped develop an innovative freeze/thaw chamber as well as the carrier system to protect, transport, and store in an ergonomically sound solution.

A Very Controlled Process

The freezing chamber required parallel moving pressure plates to
maintain maximum surface area for optimal freezing. The challenge
was that the large chamber and moving plates had to be plumbed for
coolant and yet still operate at minus 70 degrees Celsius. The second main challenge was that during the freezing process, the entire device needed to be slowly agitated through a rocker arm that had to swing 800 pounds of stainless steel and pharma bags to remove any trapped bubbles. SartoriusInsight followed a very rigorous process plan including innovative concept development, digital modeling and ultimately multiple rounds of breadboarding and prototyping all under a strict quality system and requirements tracing process.

Protection at a Cost

The next challenge in this system was to move these frozen bags around in the safest possible way. A two inch drop onto the edge of a table could cause a tear in the fluid containers and would compromise the very expensive biomaterials. Insight developed a frame system that would accommodate a 5L, 2L, and 1L flexible container. The solution also included the design of a transport cart that allowed the very heavy bag and frame assembly to be easily moved from freezer to storage. The end solution was extremely successful and is utilized by pharmaceutical processing giants such as Amgen.

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