MODULAR SINGLE-USE KITS AND PROCESSES FOR THE PREPARATION OF BIOLOGICAL MATERIAL

Abstract

The invention relates to standardized and optimized modular single-use kits and methods for the sterile or non-sterile preparation of biological material, such as cells or tissue, for immediate use, further preparation, or storage. These single-use kits comprise at least one single-use component necessary for the preparation of biological material according to a particular process as indicated in the instructions accompanying each specific type of single-use kit, which presents a unique method for using that particular type of single-use kit. The single-use kit according to the invention comprises at least one modular single-use packaging frame, in which is arranged at least one modular single-use tray bearing an identification label, where at least one single-use component is arranged.The identification label on each modular, single-use tray corresponds to a sequence of steps described in the instructions for use accompanying each single-use kit. The single-use kits according to the invention facilitate and enhance a healthcare practitioner's ability to prepare biological material for research, diagnostic, and therapeutic purposes in a practical, consistent, repeatable, safe, and efficient manner.