<p class="MsoBodyText"><span lang="EN-GB">This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document includes requirements and guidance relative to the overall topic of aseptic processing.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.</span></p>
Registration number (WIID)
77151
Scope
<p class="MsoBodyText"><span lang="EN-GB">This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document includes requirements and guidance relative to the overall topic of aseptic processing.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.</span></p>
