Miltenyi Biotec CliniMACS Formulation Unit User manual

CliniMACS® Formulation Unit
User Manual
For U.S. CAUTION:
Clinical Research System. Limited by Federal (or United States) Law to
Investigational Use or under an FDA Approval.
Version 2
Original instructions

The CliniMACS Formulation Unit is a MACS GMP Instrument. MACS GMP Instruments are for research use and
exvivo cell culture processing only, and are not intended for human invivo applications. They are intended to be
used as manufacturing equipment for cell-based medicinal products. MACS GMP Instruments are manufactured
and tested under a quality management system (ISO 13485) and are in compliance with relevant GMP guidelines.
CAUTION: Clinical Research System. Limited by Federal (or United States) Law to Investigational Use or under an
FDA Approval. In the USA, products of the CliniMACS Product Line are available for use only under an approved
Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
Unless otherwise specically indicated, Miltenyi Biotec products and services are for research use only and not for
therapeutic or diagnostic use.
Copyright © 2022 Miltenyi Biotec and/or its aliates. All rights reserved.
No part of this publication may be reproduced, stored in a retrieval system, transmitted, published, or distributed in
any form or by any means, electronically, mechanically, by photocopying, microlming, recording, or otherwise,
without the prior written consent of Miltenyi Biotec; however, notwithstanding the foregoing, the owners of the
CliniMACS Prodigy System may make copies solely for purposes of training personnel in the use and servicing of the
unit within their business or organization.
CliniMACS, CliniMACS Prodigy, MACS, and the Miltenyi Biotec logo are registered trademarks or trademarks of Miltenyi
Biotec B.V. & Co. KG and/or its aliates in various countries worldwide. All other trademarks mentioned in this
document are the property of their respective owners and are used for identication purposes only.

CliniMACS® Formulation Unit
User Manual
Issued: 2022-10
38031/03
For U.S. distributed by:
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
Miltenyi Biotec Inc.
2303 Lindbergh Street
Auburn, CA 95602
USA
Miltenyi Biotec Technical Support
[phone]
technicalsuppor[email protected]
www.miltenyibiotec.com

3
Essential information
This user manual provides instructions, warnings, precautions, and other
important information for the use of the CliniMACS Formulation Unit. For
information on specic applications related to the CliniMACS Formulation Unit,
please refer to the user manual issued for the respective application. Further
safety information regarding the operation of the CliniMACS Formulation Unit in
connection with the CliniMACS Prodigy® System is provided in the CliniMACS
Prodigy User Manual (Instrument).
Equipment safety may be compromised. Equipment safety may be
compromised if the instrument is not used according to the
manufacturer’s instructions.
The operation of the CliniMACS Formulation Unit must be performed by
professional users only. Before putting the CliniMACS Formulation Unit
into operation, the operator must read and understand the safety
information, warnings, precautions, and instructions for proper
operation of the CliniMACS Formulation Unit provided in this user manual
(including, without limitation, the safety information in chapter3
“Important safety information” of this document) and in the CliniMACS
Prodigy User Manual (Instrument), and in any safety-related
recommendations issued by Miltenyi Biotec. Pay special attention to all
warnings displayed on the CliniMACS Prodigy, or provided with CliniMACS
Formulation Unit, consumables and accessories. Adhere to all
instructions and procedures at all times during the operation of the
instrument, conrming that all safety information, warnings,
precautions, and instructions are observed. Failure to follow the safety
information, warnings, precautions, and instructions contained in the
instructions for use could result in instrument malfunction, property
damage, personal injury, and/or death.
Retain the user manuals for future reference. They should be kept
accessible and readily available together with all other safety and
operating documentation during the entire life cycle of the instrument
for all personnel responsible for installation, operation, and
maintenance.

4

5
Table of contents
1 Introduction 7
1.1 General information 7
1.1.1 CliniMACS Formulation Unit Information 8
2 Glossary 9
2.1 Graphical depiction 9
2.2 Glossary of symbols and terms 10
3 Important safety information 11
3.1 Safety instructions for the CliniMACS Formulation Unit 14
3.1.1 Usage and installation 14
3.1.2 Hazards of electric shock and spread of re 15
3.1.3 Mechanical hazards 17
3.1.4 Chemical and biological hazards 17
3.1.5 Servicing and transport 17
4 The CliniMACS Formulation Unit 19
4.1 Regulatory information 19
4.1.1 Intended use 19
4.1.2 Rationale 20
4.1.3 Compliance 20
4.2 Technical data 21
4.3 Components of the CliniMACS Formulation Unit 23
4.3.1 Pinch valves 24
4.3.2 Liquid sensor 24
4.3.3 Mounting guide and locking clasp 24

6
4.4 Unpacking and installation 24
4.4.1 Scope of supply 24
4.4.2 Unpacking 25
4.4.3 Installation 25
4.4.4 Positioning 29
4.4.5 Transport 29
4.5 Cleaning and disinfection 30
4.6 Maintenance 31
4.6.1 Servicing 31
4.6.2 Instrument disposal 31
5 The CliniMACS Formulation Unit and the CliniMACS Prodigy
Cell & Gene Therapy Manufacturing System 33
5.1 The CliniMACS Formulation Unit and CliniMACS
Prodigy Cell & Gene Therapy Manufacturing System components 33
5.2 Additional materials and equipment 33
5.3 Limitation 34
5.4 Warnings and precautions regarding the process 34
6 Troubleshooting 35
7 Legal notes 37
7.1 Limited warranty 37
7.2 Trademarks 38
7.3 EC Declaration of conformity 39
7.4 UK Declaration of conformity 40
Appendix 41
Guidanceandmanufacturer’sdeclaration
onelectromagnetic compatibility

7
INTRODUCTION
1
1
Introduction
1.1 General information
The CliniMACS System oers a set of tools that enables high-quality
standardized cell processing for dierent applications. The CliniMACS System is
based on the high-quality standardized cell processing and the magnetic cell
separation technology (MACS® Technology) developed by Miltenyi Biotec.
The CliniMACS Formulation Unit is an instrument accessory for the nal
formulation and sampling of eukaryotic cells in combination with the CliniMACS
Prodigy. The CliniMACS Formulation Unit enables the user to take cell samples
during or after processing by the CliniMACS Prodigy.
The CliniMACS Formulation Unit is intended to be used in combination with the
following components only: CliniMACS Prodigy, CliniMACS Reagents, CliniMACS
Prodigy Tubing Sets, and the CliniMACS PBS/EDTA Buer.
The dierent applications related with the CliniMACS Formulation Unit require
the use of specic CliniMACS Materials as well as additional materials and
equipment as described in this manual and in the CliniMACS Prodigy User
Manual issued for the respective application (see also section5.1).

8
1.1.1 CliniMACS Formulation Unit Information
Record below the model and serial number located on the back of the
CliniMACS Formulation Unit. Refer to these numbers when requesting
information about the instrument or when requesting instrument service.
Catalogue no. (REF):
Serial no. (SN):

9
GLOSSARY
2
2
Glossary
2.1 Graphical depiction
The following chart depicts the panels used in this user manual to inform the
user about potential risks if the outlined warnings and precautions are not
followed. The hazard level classies the hazard, as described below. The level,
type, and source of the hazard, as well as potential consequences, prohibitions,
and measures are indicated as follows. Icons on the left side specify the risk.
Indicates a hazardous situation that, if not avoided, could result in death
or serious injury
Indicates a hazardous situation that, if not avoided, could result in minor or
moderate injury
Indicates information considered important, but not hazard-related
(e.g.,messages relating to property damage)
IMPORTANT
Advises the user of important practices or information not related to personal injury
nor property damage

10
2.2 Glossary of symbols and terms
An overview of symbols and terms used for the CliniMACS Prodigy System is
provided in the CliniMACS Prodigy User Manual (Instrument). The glossary of
symbols depicts the symbols used for labeling of the CliniMACS Products.

11
IMPORTANT SAFETY INFORMATION
3
3
Important safety information
Equipment safety will be compromised if the CliniMACS Formulation Unit
is not used according to the manufacturer’s instructions. The operation
of the instrument must be performed by professional users only. Before
putting the instrument into operation, carefully read and understand the
safety information, warnings, precautions, and instructions for proper
operation of the instrument provided in the instructions for use of the
CliniMACS Formulation Unit components (including, without limitation,
the safety information in this chapter) and in any safety-related
recommendations issued by Miltenyi Biotec. Pay special attention to all
warnings on the CliniMACS Prodigy and CliniMACS Formulation Unit or
provided with consumables and accessories. The operator must adhere to
all instructions and procedures at all times during the operation of the
instrument, conrming that all safety information, warnings,
precautions, and instructions are observed.
Retain the user manuals for future reference. They should be kept
accessible and readily available together with all other safety and
operating documentation during the entire life cycle of the instrument
for all personnel responsible for installation, operation, and
maintenance.

12
Hazards to users, instrument damage, and/or malfunction, unpredictable
results, premature wear and tear, and/or reduced life time of the
instrument if the following safety information, warnings, precautions,
and instructions are not observed at all times when using the instrument.
Observe the following safety information, warnings, precautions, and
instructions at all times when using the instrument.
• Always operate, handle, use, and maintain the CliniMACS Formulation Unit in
accordance with the safety information, warnings, precautions, instructions
and recommended procedures provided in the CliniMACS Formulation Unit
User Manuals and other written instructions issued by Miltenyi Biotec. Do
not deviate from these operating instructions and procedures.
• Always ensure that the CliniMACS Formulation Unit is operated, handled,
used, and maintained only by appropriately skilled and professional
personnel familiar with the construction, operation, and hazards involved
with the instrument. The instrument is intended for the use in the
professional facility healthcare environment. The instrument is not intended
to be used near active HF surgical equipment. The customer or user should
assure that it is used in such an environment.
• Always operate, handle, use, and maintain the CliniMACS Formulation Unit in
compliance with all applicable laws, rules, regulations and administrative
provisions, including, without limitation, all regulations regarding health and
safety at work and, as appropriate, the safety of devices, as applicable at the
location where the CliniMACS Formulation Unit is operated.
• Always use the CliniMACS Formulation Unit for its intended purpose only (in
accordance with the product documentation and within its performance
limits), and not in any other manner or for any other purpose.
• Never use the CliniMACS Formulation Unit with consumables, parts, or
accessories other than those approved by Miltenyi Biotec, to ensure safe and
proper operation of the instrument. Note: The use of consumables, parts, or
accessories not expressly approved by Miltenyi Biotec could void your
warranty and/or invalidate your authority to operate this instrument under
applicable regulations.

13
IMPORTANT SAFETY INFORMATION
3
• Always follow the maintenance recommendations of Miltenyi Biotec and
appropriate product standards. Note: Maintenance and service of the
CliniMACS Formulation Unit must only be performed by authorized local
Miltenyi Biotec Service Provider. Conrm that the instrument is not put into
operation unless and until all periodic maintenance and instrument safety
checks have been successfully performed.
• Defects should be addressed immediately. If there is any doubt regarding
the proper functioning of the instrument, do not use the instrument and
contact the authorized local Miltenyi Biotec Service Provider or Miltenyi
Biotec Technical Support as soon as possible.
• Never change or modify the CliniMACS Formulation Unit except with
Miltenyi Biotec’s prior written approval. Note: Changes or modications to
this instrument not expressly approved by Miltenyi Biotec could void your
warranty and/or invalidate the operator’s authority to operate the
instrument under applicable regulations.
Risk of death, serious personal injury, and/or property damage,
instrument malfunction, or damage, premature wear and tear, and
reduced instrument life time. Failure to comply with the safety
information, warnings, precautions, and instructions in the CliniMACS
Formulation Unit User Manuals (and in other safety related publications
issued by Miltenyi Biotec for use with your instrument) could lead to
improper or incorrect use, handling or care of the product and cause a
hazard, and could result in death, serious personal injury, and/or
property damage, instrument malfunction, or damage, premature wear
and tear, and reduced instrument life time, and may void the warranty
and/or invalidate the authority to operate the instrument under
applicable regulations. Miltenyi Biotec accepts no liability for
consequences arising from failure to comply with the safety information,
warnings, precautions, and instructions provided herein.
If concerned about the safe use of the CliniMACS Formulation Unit or require
additional safety information regarding the CliniMACS Formulation Unit and its
components, contact the authorized local Miltenyi Biotec Service Provider or
Miltenyi Biotec Technical support.

14
3.1 Safety instructions for the CliniMACS
Formulation Unit
In the event of unexpected process abortion or messages on the screen of the
CliniMACS Prodigy that advises the operator to contact technical support,
immediately contact the Miltenyi Biotec Technical Support. If secure operation is
no longer possible, immediately switch o the CliniMACS Prodigy and
disconnect the power cord of the CliniMACS Prodigy and contact Miltenyi Biotec
Technical Support or an authorized local Miltenyi Biotec Service Provider.
3.1.1 Usage and installation
Risk of improper operation due to increased electromagnetic emissions
or decreased electromagnetic immunity. The use of consumables,
accessories, transducers, and cables other than those specied or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation. Electrical equipment
requires special precautions regarding electromagnetic compatibility
(EMC) and must be installed and placed in service according to the EMC
information (see “Appendix”). Portable and mobile RF communications
equipment can aect medical electrical equipment. Only use the
instrument with accessories, transducers, and/or cables approved by
Miltenyi Biotec.
Risk of process failure. If alarm signals are not recognized and the required
actions are not executed or conrmed there is the risk of process failure.
Conrm that optical and acoustical alarm signals can be recognized by the
operator at any time during the process.
Risk of injury. If installed improperly without consulting this user manual, the
CliniMACS Formulation Unit may lead to injury. The installation of the
CliniMACS Formulation Unit must be performed as described in section4.4
of this user manual. The Formulation Unit must be installed on a CliniMACS
Prodigy which is placed evenly on a at and stable surface, which is capable
of supporting at least 120kg and free of vibrational or other mechanical
forces.

15
IMPORTANT SAFETY INFORMATION
3
The CliniMACS Formulation Unit may be used repeatedly. It is not intended for
disposal after single use. Contact the local authority governing electrical power
supply, building construction, maintenance, or safety for more information
regarding the installation of the equipment.
Risk of damage to the tubing set. The tubing set can be damaged if the tubing is
streched by the bags hanging over the edge of the table. Leave sucient space
(approx. 15cm) for bags for tubing set installation in front of the CliniMACS
Formulation Unit.
3.1.2 Hazards of electric shock and spread of re
Electrical instruments pose the risk of an electric shock, electrical short, and
overheating. Electric shock may lead to severe personal injury or death.
An electrical short and overheating may lead to the spread of re.
The CliniMACS Formulation Unit is a Protection Class I device and may only be
connected to the CliniMACS Prodigy. The CliniMACS Prodigy itself may only be
plugged into an outlet with a grounded connection.
Electronic equipment may emit sparks that could ignite combustible vapors or
dusts leading to explosion or spread of re.
Risk of electric shock, electrical short, and spread of re. Electric shock
may lead to severe personal injury or death. The housing of the
instrument reduces the risks of electric shock, electrical short, and spread
of re. Opening any cover of the instrument interrupts this protective
measure. Do not remove or penetrate any cover of the instrument. Only
authorized local Miltenyi Biotec Service Provider may open the
instrument or exchange spare parts. Do not use the instrument in case of
visible damage or if it has been dropped. Contact
Miltenyi Biotec Technical Support.
Risk of electric shock or damage to the instrument. Risk of electric shock
or damage to the instrument if the instrument is cleaned with excessive
amount of cleaning or while switched on. Before cleaning or disinfection
of the CliniMACS Formulation Unit, disconnect the instrument from the
power supply. Unplug the mains plug of the CliniMACS Prodigy to
disconnect the CliniMACS Formulation Unit from the power supply. Only
use the originally supplied power cord.

16
If ames or smoke appear, immediately switch o the instrument, unplug
it from the electrical outlet, and contact an authorized Miltenyi Biotec
service provider or Miltenyi Biotec Technical Support.
Risk of electric shock or spread of re. The instrument is intended for
indoor use only. Water ingress may lead to an electrical short circuit and
the risk of electric shock or spread of re. Do not use the instrument in a
wet or damp location or if it has been exposed to moisture. Avoid high
humidity or condensation and protect the instrument from contact with
water. Special care must be taken while handling uids. Clean up
spillages immediately. Do not allow uids to enter the interior of the
instrument. Avoid ingress of any liquid into the valves. Do not operate
the instrument if liquids have spilled into the instrument. Fluid
containers must be handled with caution when in the area of the
CliniMACS Formulation Unit. After moving the instrument from a cold
environment, such as a cold room at +4°C (+39°F), to room temperature,
condensing liquid droplets may form inside the instrument. It is
necessary to wait for the instrument to dehumidify before operating the
instrument. Do not use liquid or aerosol cleaning agents; always use a
damp cloth.
Risk of overheating. Ambient air temperature may not be adequate to cool
the instrument to acceptable operating temperatures without adequate
circulation. Conrm the room in which you operate the instrument has
adequate air circulation.
The instrument should not be placed next to radiators, heat registers, stoves,
or other pieces of equipment (including ampliers) that produce heat.
Allow sucient space for air circulation around the CliniMACS Prodigy as
described in the CliniMACS Prodigy User Manual (Instrument). Prevent direct
exposure of the instrument to sunlight. Do not place the instrument within a
built-in apparatus or a conned space such as a shelf rack unless the
apparatus has been specically designed to accommodate the instrument,
proper ventilation is provided, and the positioning instructions for the
instrument have been followed.
Conrm the power CAN connector to the CliniMACS Prodigy is easily accessible
and located as close to the operator of the instrument as possible. If it is
necessary to disconnect the power supply, unplug the power cord of the
CliniMACS Prodigy from the power outlet.

17
IMPORTANT SAFETY INFORMATION
3
3.1.3 Mechanical hazards
Risk of internal damage. Movement or vibration may aect the instrument.
Do not place the instrument next to equipment that vibrates or can cause
the instrument to move. Do not lean on the CliniMACS Formulation Unit.
3.1.4 Chemical and biological hazards
Risk of severe personal injury or death. Depending on the biological
material used, contamination or infection may lead to severe personal
injury or death. Always wear personal safety equipment in accordance
with warnings and precautions, in particular if biohazardous material is
or has been used.
Wear protective gloves, protective clothing, and safety goggles to prevent
contact with skin and eyes. Defective or inadequate safety equipment might
endanger the operator. If hazardous material has been used or spilled, the
operator must take care to thoroughly decontaminate the instrument.
After running the process and prior to decontamination, the CliniMACS
Formulation Unit should be treated as a biohazard (see section4.5). Waste
disposal must be in accordance with local regulations.
3.1.5 Servicing and transport
Hazards to users, unpredictable results, instrument malfunction or
damage, premature wear and reduced lifetime of the instrument.
Improper or incorrect servicing or repair of the instrument can cause
hazards to users, lead to unpredictable results, instrument malfunction
or damage, premature wear and reduced lifetime of the instrument, and
may void the warranty. Unless otherwise specically noted in this user
manual, do not service the CliniMACS Formulation Unit. Service and
repair may only be performed by authorized local Miltenyi Biotec Service
Provider.

18
Using unauthorized replacement or spare parts can cause malfunction of the
instrument and impair results. Miltenyi Biotec does not honor any warranty or
accept any responsibility for instrument failure or damages resulting from the
use of inappropriate replacement or spare parts. After completing any services
or repairs, authorized local Miltenyi Biotec Service Providers perform all required
safety checks to ensure that the instrument is fully functional.
For information about Miltenyi Biotec’s instrument service and support
arrangements, contact the authorized local Miltenyi Biotec Service Provider or
Miltenyi Biotec Technical Support
Chemical and biological hazard. Risk of chemical or biological hazards
due to contaminated surfaces. If the instrument needs to be shipped back
to the manufacturer for service, decontaminate the instrument from any
hazardous material prior to shipment. For details regarding proper
decontamination, refer to the instructions in section4.5.
Risk of internal damage. Internal damage can occur if the instrument is
subjected to excessive vibration or is dropped. If transportation of the
CliniMACS Formulation Unit is required, contact the authorized local Miltenyi
Biotec Service Provider or Miltenyi Biotec Technical Support.