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�p���v��1.Policy making of �gaseptic transfer interface�h
��Survey of needs for aseptic transfer interface: We discussed with the domestic companies related for regenerative medicine concerning the current potential of the interface availability and clarified its importance in terms of seeds from the manufacturer as well as the needs for users.
��Planning for the primary concept of aseptic transfer interface: Based on the survey, the specifications for decontamination as well as connectivity in aseptic transfer interface were planned. In addition, we confirmed the conventional protocols in several culture operations to estimate the operability in the isolator system as well as the requirement specification for the aseptic transfer interface.
2.Assembling Aseptic transfer interface (Shibuya Kogyo Co., Ltd.)
��Design of Aseptic transfer interface: We designed a prototype considering the unit�fs size, configuration and material of construction as well as decontamination time when it is connected. The adequacy of design was verified by reviewing drawings and referring to the information which is within the public domain, and test data.
��Assembling a Connecting Device Necessary for Prototype and its Verification Test: We assembled a prototype Aseptic transfer interface. We also prepared a set of peripheral connecting device that is necessary for verification of the prototype and completed assembling of the prototype and peripheral connecting device.
3.Investigation and validating for the practicality of the aseptic transfer interface (National Institute of Advanced Industrial Science and Technology)
��Investigation of the concept of an aseptic transfer interface: The interface was investigated in view points of operation, function and aseptic procedures.
��Validation of the aseptic conditions: the data were obtained from the decontamination levels of the pass-box and several containers. The data were also correlated with the viability of rat mesenchymal stem cells (MSCs) culture.
4.Action of proposing to the International Organization for. Standardization (ISO)
��Consensus development of ISO/TC198/WG9: At the working Group 9 (ISO/TC198/ WG9) concerning the septic processing of the ISO Technical Committee 198 held in Guangzhou, China on September 2010, we discussed the basic concept of the aseptic transfer interface with WG9 board members to reach a consensus of the aseptic processing of tissue engineered medical products.
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