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<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">This document specifies minimum requirements and general considerations for bioreactor</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">equipment, consisting of hardware, software and connectors, used in the manufacturing of cells</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">for therapeutic use. This includes equipment used for growth/expansion, differentiation including</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">stir tanks, fixed beds, rocking platforms, and hollow fiber systems.</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">This document gives guidance on the design, use and maintenance of bioreactor equipment and</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">equipment systems to both suppliers and users from aspects including the target parties, i.e.</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">supplier or user, and phase of involved task, i.e. design, use or maintenance.</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">This document is applicable to bioreactors using real time monitoring, automation, and closed</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">systems.</span></p>
Reģistrācijas numurs (WIID)
94655
Darbības sfēra
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">This document specifies minimum requirements and general considerations for bioreactor</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">equipment, consisting of hardware, software and connectors, used in the manufacturing of cells</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">for therapeutic use. This includes equipment used for growth/expansion, differentiation including</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">stir tanks, fixed beds, rocking platforms, and hollow fiber systems.</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">This document gives guidance on the design, use and maintenance of bioreactor equipment and</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">equipment systems to both suppliers and users from aspects including the target parties, i.e.</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">supplier or user, and phase of involved task, i.e. design, use or maintenance.</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">This document is applicable to bioreactors using real time monitoring, automation, and closed</span></p>
<p class="MsoNormal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-fareast-theme-font: minor-fareast; mso-no-proof: yes;">systems.</span></p>
