Description
- CliniMACS Plus Essential Service Contract: The Essential Service Contract includes scheduled maintenance visits. Routinely wearing parts are replaced at no charge, and spare parts are provided in case of a necessary repair. Service costs such as labor and travel fees related to the maintenance visit are covered.
- CliniMACS Plus Essential Service Premium Contract: In addition to the Essential Service Contract, a loaner instrument will be provided, if your instrument must be taken off-site for repair.
- CliniMACS Plus Always-On Service Contract: In addition to the Essential Service Contract, 24/7 clinical technical support is provided for the CliniMACS Plus workflow.
- CliniMACS Plus High-Compliance Service Contract: In addition to the Always-On Service Contract, free-of charge operational requalification of the instrument is covered when deemed necessary.
- CliniMACS Plus IQ/OQ Documentation: We provide the necessary official documentation for installation and operational qualifications required to maintain GMP standards.
- CliniMACS Plus OQ: includes the Operational Qualification (OQ) for the CliniMACS Plus Platform.
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Disclaimer
The CliniMACS® System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.
In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. 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. For the manufacturing and use of target cells in humans the national legislation and regulations - e.g., for the EU the Directive 2004/23/EC ("human tissues and cells"), or the Directive 2002/98/EC ("human blood and blood components") - must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.
In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved as a Humanitarian Use Device (HUD), authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this indication has not been demonstrated. Other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application, Investigational Device Exemption (IDE) or FDA approval.
CR/GMP products are for ex vivo cell processing only, and are not intended for human in vivo applications. CR/GMP products are designed, manufactured and tested under an ISO 13485 quality management system and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The manufacturing and testing of CR/GMP products of biological origin are in compliance with EP chapter 5.2.12 for “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products”.
Overview
Miltenyi Biotec offers a range of service contracts aimed at meeting the needs of our customers. The service contracts include technical support and annual preventive maintenance programs to ensure maximum performance of the CliniMACS® Plus Instruments over time. Additional service contracts are available, providing features such as 24/7 clinical technical support and operative requalification of instruments when necessary.
