Thermo Scientific A44769, Руководство пользователя

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Protocol file
• Protocol files for the Rotea
™
instrument will be stored and transmitted in JSON format.
• The JSON format provides an extensible structure to support future devices and software
functions.
• The Rotea
™
instrument's embedded control supports one only protocol file.
• The protocol file is re-written to the instrument each time the protocol is run.
Protocol metadata
Protocol metadata entries provide the means to adjust fixed, qualified protocols to respond to process
conditions.
• Metadata is supplied at the time the protocol is transferred to the instrument
• The metadata populates variables that are needed to complete the protocol definition
• This is managed by the IAL as part of the protocol transfer actions
MES interface
A Manufacturing Execution System (MES) interface is provided to enable processing by the Rotea
™
instrument within a qualified clinical cGMP environment.
Background
The CTS
™
Rotea
™
Counterflow Centrifugation System is for research use or manufacture of cell, gene or
tissue-based products.
For use in a qualified manufacturing processes, the instrument, Single-Use Kit and protocol must be
qualified and maintained fit for purpose for the application.
When a qualified process is run, a record is required to verify that the process was performed in the
formally defined way. If any variation to the process operations occur, then such events need to be
documented and formally reviewed before the product can be released.
An MES interface is a communication system that links the CTS
™
Rotea
™
Counterflow Centrifugation
System to a formally qualified electronic batch management system and associated data capture and
record management functions.
The MES system is responsible for formal identification of users, their level of training, recording of
equipment, consumables and events associated with each processing run.
The CTS
™
Rotea
™
Graphical User Interface (GUI) does not support this formal data capture activity.
If an automated electronic interface is part of the implementation plan for CTS
™
Rotea
™
Counterflow
Centrifugation System, then the MES interface provides that tool.
Chapter 4
OPC-UA interface
MES interface
4
CTS ™ Rotea ™ Counterflow Centrifugation System User Guide
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