Complete traceability BAG FOR CRYOPRESERVATION OF PERIPHERAL STEM CELLS AND MECHANICALLY DIGESTED LIPOASPIRATE (LML) PeriStem is equipped with one aliquot for testing the manipulated biological materials collected. The aliquot has a silk-screened unique and univocal number which is the same on the main bag to guarantee the complete traceability. PeriStem is the result of Biomed Device’s experience and long-term research: each technical detail has been designed and developed to offer a complete and flexible Device, fulfilling every user needs. PeriStem complies with the current applicable Guidelines concerning treatment, manipulation and cryopreservation of stem cells and mechanically digested lipoaspirate (LML) obtained from autologous adipose tissue. The bag has been conceived and designed to satisfy the requirements of health care professionals. The use of high quality materials certified for cryopreservation ensures reliability over time and ease of use. Intelligent label PeriStem is DMSO-resistant. Components have been tested to resist contact with 10% DMSO solution up to 120 minutes. (Ethylene Vinyl Acetate) PeriStem and dedicated cover bag are made in EVA. The cover bag combines strenght, flexibility, transparency, low temperature endurance and resistance to impact and perforation. The cover bag ensures resistance to cryopreservation in liquid Nitrogen up to -196°C for long time period. Bag and cover bag sizes are compatible with the most common storage containers. Complete traceability The connected aliquot is univocally identified by a numerical code, printed also on the bag, to ensure the correct identification and complete traceability throughout the entire Device’s shelf life. The presence of the numerical code on both the aliquot and the bag allows identification and traceability. Additionally, the bag is equipped with a bar code that can be read with standard electronic pens in order to be directly recorded in the internal management system. Intelligent labelling PeriStem is equipped with a pocket suitably dimensioned for label application in order to avoid any direct contact with bag’s surface or contamination of the biological materials preserved in compliance with current applicable Guidelines. Aliquot for testing PeriStem is equipped with a single one aliquot for biological testing with a maximum filling volume equal to 1,5 mL allowing sampling of the biological material collected with no need for opening the circuit or thawing the entire bag. The aliquot is directly connected to the bag; connection is ensured over all the thawing cycle. The label does not come into direct contact with the bag Resistance and versatility PeriStem has been designed to offer the highest quality standards and is easy to use. PeriStem bag and the dedicated cover bag are provided sterile, realized with biocompatible materials able to keep unchanged over time the original properties of resistance, flexibility and transparency, essential for a clear and rapid reading of the data reported in labels. All welds are single tested against crash test requirements and compliant with the thawing cycle according to applicable Guidelines. Tubes, filling lines, Luer locks connections and the spike ports are DMSO-resistant and compliant with the most commonly used sterile welding systems available. PeriStem is packed in double pouch to allow its use in Sterile Room and preserve sterility requirement up to the point of care. 4 Resistance, flexibility and transparency over time PeriStem maintains resistance, flexibility and transparency over time. All welds are single tested against crash test requirements and compliant with the thawing cycle according to applicable Guide Lines. Certified quality PeriStem is a Class IIa Medical Device marked according to current European Legislation. PeriStem is manufactured in compliance with provisions of UNI EN ISO 13485, Current Edition. Biomed Device has implemented and maintains a Quality Management System certified according to reference Standards UNI EN ISO 9001 and UNI EN ISO 13485, Current E

LITERATURE REFERENCES LONG-TERM EXPERIENCES IN CRYOPRESERVATION OF MOBILIZED PERIPHERAL BLOOD STEM CELLS USING A CLOSED-BAG SYSTEM: A TECHNOLOGY WITH POTENTIAL FOR BROADER APPLICATION. 1 Silvia Spoerl , Robert Peter , Dagmar Wascher , Mareike Verbeek , Helge Menzel , Christian Peschel and Angela M. Krackhardt . 1 Medizinische Klinik III, Klinikum rechts der Isar, Technische Universitat Munchen, Technische Universitat Munchen, Munchen, Germany Department of Hematology and Oncology, St Franziskus-Hospital, Malteser Norddeutschland, Flensburg, Germany. TRANSFUSION Volume 55, November 2015 A NEW...