Protocol File; Protocol Metadata; Mes Interface; Background - Thermo Scientific Gibco CTS Rotea User Manual

Protocol file

• Protocol files for the Rotea
• The JSON format provides an extensible structure to support future devices and software
functions.
™
• The Rotea
• 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
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
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
If an automated electronic interface is part of the implementation plan for CTS
Centrifugation System, then the MES interface provides that tool.
CTS ™ Rotea ™ Counterflow Centrifugation System User Guide
™
instrument will be stored and transmitted in JSON format.
instrument's embedded control supports one only protocol file.
™
Counterflow Centrifugation System is for research use or manufacture of cell, gene or
™
Graphical User Interface (GUI) does not support this formal data capture activity.
Chapter 4 OPC-UA interface
MES interface
™ ™
Rotea Counterflow Centrifugation
™ ™
Rotea
4
™
Counterflow
89