Related Manuals for Miltenyi Biotec CliniMACS Formulation Unit
Summary of Contents for Miltenyi Biotec CliniMACS Formulation Unit
- Page 1 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...
- Page 2 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.
- Page 3 CliniMACS® Formulation Unit User Manual Issued: 2022-10 38031/03 For U.S. distributed by: Miltenyi Biotec B.V. & Co. KG Miltenyi Biotec Inc. Friedrich-Ebert-Straße 68 2303 Lindbergh Street 51429 Bergisch Gladbach Auburn, CA 95602 Germany Miltenyi Biotec Technical Support +49 2204 8306-3803 technicalsupport@miltenyi.com...
- Page 5 Essential information This user manual provides instructions, warnings, precautions, and other important information for the use of the CliniMACS Formulation Unit. For information on specific 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®...
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Page 7: Table Of Contents
General information 1.1.1 CliniMACS Formulation Unit Information Glossary Graphical depiction Glossary of symbols and terms Important safety information Safety instructions for the CliniMACS Formulation Unit 3.1.1 Usage and installation 3.1.2 Hazards of electric shock and spread of fire 3.1.3 Mechanical hazards 3.1.4... - Page 8 Cleaning and disinfection Maintenance 4.6.1 Servicing 4.6.2 Instrument disposal The CliniMACS Formulation Unit and the CliniMACS Prodigy Cell & Gene Therapy Manufacturing System The CliniMACS Formulation Unit and CliniMACS Prodigy Cell & Gene Therapy Manufacturing System components Additional materials and equipment Limitation...
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Page 9: Introduction
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 Buffer. -
Page 10: Clinimacs Formulation Unit Information
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):... -
Page 11: Glossary
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 classifies 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. -
Page 12: Glossary Of Symbols And Terms
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. -
Page 13: Important Safety Information
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... - Page 14 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.
- Page 15 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...
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Page 16: Safety Instructions For The Clinimacs Formulation Unit
Miltenyi Biotec Technical Support. If secure operation is no longer possible, immediately switch off 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. -
Page 17: Hazards Of Electric Shock And Spread Of Fire
Electric shock may lead to severe personal injury or death. An electrical short and overheating may lead to the spread of fire. 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. - Page 18 If flames or smoke appear, immediately switch off 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 fire. The instrument is intended for indoor use only.
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Page 19: Mechanical Hazards
Risk of internal damage. Movement or vibration may affect 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. - Page 20 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.
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Page 21: The Clinimacs Formulation Unit
CliniMACS Prodigy only. The CliniMACS Formulation Unit is for research use and in vitro cell culture pro ces - sing only. It is intended to be used by professional users in a GMP environment. -
Page 22: Rationale
(EudraLex Vol. 4) have to be followed when using the CliniMACS Formulation Unit for manufacture of cell-based medicinal products in Europe. For operating the CliniMACS Formulation Unit, only the stated products defined in the respective applications must be used with and connected to the CliniMACS Prodigy. -
Page 23: Technical Data
IMPORTANT Any serious incident that has occurred in relation to this product should be reported to Miltenyi Biotec B.V. & Co. KG using the contact information provided. 4.2 Technical data Safety and performance of the instrument may be compromised if the CliniMACS Formulation Unit is used outside its specifications. - Page 24 • Consult the dealer or an experienced radio/TV technician for help. Changes or modifications of the instrument, unless expressly approved by Miltenyi Biotec, may void the authority to operate the instrument pursuant to FCC 47 CFR.
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Page 25: Components Of The Clinimacs Formulation Unit
The following section describes the components of the CliniMACS Formulation Unit. The key components of the CliniMACS Formulation Unit are the 13 pinch valves, the liquid sensor, the mounting guide, the power cable, and the locking clasp (see Figure 4.1 and Figure 4.2). -
Page 26: Pinch Valves
CliniMACS Formulation Unit onto the bag compartment on the CliniMACS Prodigy. The locking clasp locks the CliniMACS Formulation Unit on the bottom side of the CliniMACS Prodigy. 4.4 Unpacking and installation Unpacking and installation of the CliniMACS Formulation Unit must only be performed by a professional user. -
Page 27: Unpacking
Figure 4.3: Placement of the rubber pads on the bag compartment of the CliniMACS Prodigy (top view) Hold the CliniMACS Formulation Unit with the mounting guide facing the CliniMACS Prodigy. Tilt the Formulation unit as shown in Figure 4.4 and insert the mounting... - Page 28 Bag compartment (CliniMACS Prodigy) Figure 4.4: Tilting the CliniMACS Formulation Unit for installation (right-side view) Open the locking clasp (see Figure 4.4) by pushing on the front side of the trigger, slide it towards the CliniMACS Prodigy and lock it by releasing the trigger.
- Page 29 Locking clasp (CliniMACS Formulation Unit) Figure 4.5: Right-side view of the CliniMACS Formulation Unit installed on the CliniMACS Prodigy Make sure that the CliniMACS Prodigy is switched off before connecting the CliniMACS Formulation Unit. Plug the Power-CAN plug of the CliniMACS Formulation Unit into the “Power-CAN”...
- Page 30 Main power Connector panel Figure 4.6: Location of the connector panel on the rear side of the CliniMACS Prodigy for connecting the CliniMACS Formulation Unit...
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Page 31: Positioning
F 1 3 F 1 2 F 1 1 F 1 0 Figure 4.7: CliniMACS Formulation Unit located on the Bag compartment of the CliniMACS Prodigy (front view) 4.4.5 Transport Risk of internal damage. Internal damage can occur if the instrument is subjected to excessive vibration or if it is dropped. -
Page 32: Cleaning And Disinfection
H Dust off the valves using a paper towel. IMPORTANT The surface of the CliniMACS Formulation Unit should be cleaned at regular intervals and after each application. Cleaning after unpacking before installation is also recommended. -
Page 33: Maintenance
The instrument does not require any form of calibration. Contact the authorized local Miltenyi Biotec Service Provider for Miltenyi Biotec Instrument Service and support arrangements. 4.6.2 Instrument disposal Contact Miltenyi Biotec Technical Support for final disposal. -
Page 35: The Clinimacs Formulation Unit And The Clinimacs Prodigy Cell & Gene Therapy Manufacturing System
Prodigy Cell & Gene Therapy Manufacturing System components The different applications running on the CliniMACS Formulation Unit require the use of specific CliniMACS Materials as well as additional materials and equipment as described in the CliniMACS Prodigy User Manual for the respective application. -
Page 36: Limitation
5.3 Limitation Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. 5.4 Warnings and precautions regarding the process Risk of process failure or damage to the instrument.Risk of process... -
Page 37: Troubleshooting
Troubleshooting In any case of instrument malfunction or process failure, contact the Miltenyi Biotec Technical Support: +49 2204 8306-3803 technicalsupport@miltenyi.com Visit www.miltenyibiotec.com for local Miltenyi Biotec Technical Support contact information. -
Page 39: Legal Notes
7.1 Limited warranty Except as stated in a specific warranty statement, which may accompany this Miltenyi Biotec product, or unless otherwise agreed in writing by a duly authorized Miltenyi Biotec representative, Miltenyi Biotec’s warranty for products purchased directly from Miltenyi Biotec shall be subject to the terms and conditions of sale under which it was provided to you by the respective Miltenyi Biotec sales organization. -
Page 40: Trademarks
7.2 Trademarks CliniMACS, CliniMACS Prodigy, MACS, and the Miltenyi Biotec logo are registered trademarks or trademarks of Miltenyi Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. All other trademarks mentioned in this document are the property of their respective owners and are used for identification... -
Page 41: Ec Declaration Of Conformity
7.3 EC Declaration of conformity This declaration of conformity is issued under the sole responsibility of the manufacturer: Miltenyi Biotec B.V. & Co. KG Friedrich-Ebert-Straße 68 51429 Bergisch Gladbach Germany This declaration relates exclusively to the machinery in the state in which it was placed on the market, and excludes components which are added and/or operations carried out subsequently by the final user. -
Page 42: Declaration Of Conformity
7.4 UK Declaration of conformity This declaration of conformity is issued under the sole responsibility of the manufacturer: Miltenyi Biotec B.V. & Co. KG Friedrich-Ebert-Straße 68 51429 Bergisch Gladbach Germany This declaration relates exclusively to the machinery in the state in which it was placed on the market, and excludes components which are added and/or operations carried out subsequently by the final user. -
Page 43: Appendix
EMC compliance with IEC 60601-1-2:2014 (Edition 4) has been attested for the CliniMACS Formulation Unit and the provided components (see Table A.1). Guidance and manufacturer’s declaration – Electromagnetic emissions The equipment is intended for the use in the professional facility healthcare environment. - Page 44 10 ms. Guidance and manufacturer’s declaration – Electromagnetic immunity The CliniMACS Formulation Unit is intended for use in the electromagnetic environment specified below. The customer or the user of the instrument should assure that it is used in such an environment.
- Page 45 Guidance and manufacturer’s declaration – Electromagnetic immunity to RF wireless communication equipment Test Immunity Band Maximum Distance Compliance frequency Service Modulation test level (MHz) power (W) level (V/m) (MHz) (V/m) TETRA 400 Pulse – modulation 18 Hz GMR S460, – FRS 460 ±5 kHz deviation 1 kHz sine...
- Page 46 Miltenyi Biotec provides products and services worldwide. Visit www.miltenyibiotec.com/local to find your nearest Miltenyi Biotec contact. CliniMACS, CliniMACS Prodigy, MACS, and the Miltenyi Biotec logo are registered trademarks or trademarks of Miltenyi Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. Copyright © 2022 Miltenyi Biotec and/or its affiliates. All rights reserved.