STORAGE UNIT FOR USE IN FREEZING, STORING AND THAWING BIOPHARMACEUTICAL MATERIALS CONTAINED IN A FLEXIBLE POUCH AND A METHOD OF ASSEMBLING A PROTECTION SYSTEM FOR SUCH A STORAGE UNIT

摘要

A flexible pouch is placed in a stack provided with two plates forming a protecting body (12) to sandwich and constrain the pouch. At two opposite margin portions, the protecting body has slots (51, 52, 53) or interlocking members for cooperating with positioning members of an outer holding device (HR). Between lower and upper parts of the holding device, the two plates can move during filling of the pouch and the margin portions shrink inwardly in a protecting body plane. Some of the positioning members act as stoppers (41') to have lower clearance range for shrink strokes of the protecting body in a middle part thereof, as compared to a higher clearance range (X2) at respective longitudinal end parts of the margin portions. A higher constraining effect can be obtained in a center of the pouch, to limit maximum thickness of its content, which is of interest for managing freeze/thaw operations of biopharmaceutical content of the pouch.