Clinical Manufacturing Mode; System Overview - Thermo Scientific gibco CTS DynaCellect Magnetic Separation System User Manual

Table of Contents

Advertisement

– Rocker angle: -30° to 30°
– Rocker speed: 1–30 CPM (cycles per minute)
• Export summary reports (sample ID, run ID, Single-Use Kit lot, bead lot, operator, date)
• DeltaV
system communication via OPC UA (under development)

Clinical manufacturing mode

• Locked, standardized cell processing protocols
– Cell isolation
– Cell depletion
– Bead removal
• eBatch Records
– Enable 21 CFR part 11 compliance with SAE Administrator Console Software 2.1

System overview

CAUTION! This device contains extremely powerful permanent magnets. Keep ferromagnetic and
ferromagnetically-sensitive material away from the magnetic surfaces and associated fields. Do not
bring tools, equipment or personal items containing steel, iron or other magnetic materials close to
the magnets. The strong magnetic field can erase magnetic media such as hard disc drive (HDD)
memory devices, disable ATM and credit cards, and can damage some watches. Strong magnetic
fields can also cause serious injury to persons with implanted or attached medical devices, such as
pacemakers and prosthetic parts.
The Health and Safety Officer should take all necessary steps and full responsibility to ensure that
the precautions and statements are followed and adhered to. IN NO EVENT SHALL Thermo Fisher
Scientific BE LIABLE FOR ANY SPECIAL, INCIDENTIAL OR CONSEQUENTIAL DAMAGES.
CTS
DynaCellect
Magnetic Separation System User Guide
Chapter 1 Product information
System overview
1
11

Advertisement

Table of Contents
loading

This manual is also suitable for:

A55867

Table of Contents