IF.UG.IM_R1
3. Safety Guidelines
3.1 Intended User Guide Audience
This User Guide for KrosFlo Systems is intended to be used by experienced users, working in pilot or
production facilities. Users should have advanced understandings and working experiences of
upstream and downstream processes.
Because this User Guide only focuses on the equipment set-up and its detailed operations, users
should have the support from both Process Subject Matter Expert and Automation Expert to set-up
the process parameters and operate the System.
This User Guide is intended to act as a reference only, in conjunction with other materials, such as
application notes, automation documents, component manuals, or maintenance manuals. It should
not be used as the sole source of knowledge. Users must not expect to operate the System by just
reading this User Guide.
If users do not have the above experience or technical support, or they do not understand any
instructions in this User Guide, contact Repligen for assistance or training before proceeding.
The instructions in this user guide are not a substitute for the observance of the System owner’s
company-specific regulations and requirements.
Note:
This User Guide presents and describes a sample KrosFlo System configuration. Sample HMI screens
are included that represent this configuration. As a KrosFlo System may be customized to support a
particular bioprocessing development process, your KrosFlo System hardware, automation software,
and HMI screens may differ from this sample configuration. Safety information presented in this
user guide applies to all KrosFlo Systems.
Please refer to the following system design documents included in the electronic Turn Over Package
(eTOP) for details about your KrosFlo System software and hardware configuration, and capabilities:
• Hardware Design Specification (HDS)
• Core Standard Platform Software Operations Manual (SOM)
• KrosFlo® Systems Software Operations Manual (SOM)
• Recipe Editor Software Operations Manual (SOM)
• CFR 21 Part 11 Regulatory Compliance Guidance (REG)
• General Arrangement (GA) Drawing
• Piping and Instrumentation Diagram (P&ID)
• Electrical Specifications (ES)
To Next Page
Loading...
Need help?
General
