Description
- CliniMACS Prodigy Essential Service Contract includes scheduled maintenance visits, including service costs related to the visit, such as labor and travel fees. Routinely wearing parts are replaced at no charge and spare parts are provided in case of a necessary repair.
- CliniMACS Prodigy Always-On Service Contract covers 24/7 clinical technical support for the CliniMACS Prodigy workflow in addition to scheduled maintenance visits, costs related to visits, the replacement of routinely wearing parts and spare parts needed for repairs.
- CliniMACS Prodigy High-Compliance Service Contract covers scheduled maintenance visits, costs, and replaced parts due to wear-and-tear or repair, plus an operational requalification of the CliniMACS Prodigy free of charge when deemed necessary. The contract also includes 24/7 clinical technical support.
- CliniMACS Prodigy IQ/OQ Service includes the Installation and Operational Qualification (IQ/OQ) of the CliniMACS Prodigy to provide detailed, documented evidence according to GMP standards that the equipment operates according to Miltenyi Biotec’s specifications and customer requirements.
- CliniMACS Prodigy CSV IQ/OQ Service aims to provide testing of equipment for regulatory compliance in the context of Computerized System Validation (CSV). The Service provides comprehensive software related Installation Qualification (IQ) and Operational Qualification (OQ) tests with a focus on user management and audit trail functionality to support customer CSV activities that follow the GAMP® 5 guideline. Previously performed Instrument CliniMACS Prodigy IQ/OQ is a prerequisite for this service.
- CliniMACS Prodigy OQ includes the Operational Qualification (OQ) of the CliniMACS Prodigy to provide detailed, documented evidence according to GMP standards that the equipment operates according to Miltenyi Biotec’s specifications and customer requirements.
- CliniMACS Formulation Unit IQ/OQ Service includes the Installation and Operational Qualification (IQ/OQ) of the CliniMACS Formulation Unit to provide detailed, documented evidence according to GMP standards that the equipment operates according to Miltenyi Biotec’s specifications and customer requirements.
- CliniMACS Formulation Unit OQ includes the Operational Qualification (OQ) of the CliniMACS Formulation Unit to provide detailed, documented evidence according to GMP standards that the equipment operates according to Miltenyi Biotec’s specifications and customer requirements.
- CliniMACS Electroporator Essential Service Contract includes scheduled maintenance visits, repair and firmware update services.
- CliniMACS Electroporator Always-On Service Contract covers scheduled maintenance visits, repair and firmware update services plus 24/7 technical support.
- CliniMACS Electroporator High-Compliance Service Contract covers scheduled maintenance visits, repair and firmware update services, plus an operational requalification of the CliniMACS Electroporator free of charge when deemed necessary.
- CliniMACS Electroporator Preventive Maintenance Contract includes preventive maintenance and firmware update services.
- CliniMACS Electroporator One-Time Preventive Maintenance includes one scheduled maintenance visit.
- CliniMACS Electroporator Installation Service includes instrument delivery and installation by Miltenyi Biotec-qualified personnel to ensure that the instrument is properly installed and ready to use.
- CliniMACS Electroporator Extended Warranty includes preventive maintenance, repair and firmware update services.
- CliniMACS Electroporator IQ/OQ Service includes the Installation and Operational Qualification (IQ/OQ) of the CliniMACS Electroporator to provide detailed, documented evidence according to GMP standards that the equipment operates according to Miltenyi Biotec’s specifications and customer requirements.
- CliniMACS Electroporator OQ includes the Operational Qualification (OQ) of the CliniMACS Electroporator to provide detailed, documented evidence according to GMP standards that the equipment operates according to Miltenyi Biotec’s specifications and customer requirements.
- CliniMACS Workbench IQ/OQ Service includes the Installation and Operational Qualification (IQ/OQ) of the CliniMACS Workbench to provide detailed, documented evidence according to GMP standards that the equipment operates according to Miltenyi Biotec’s specifications and customer requirements.
- CliniMACS Workbench OQ includes the Operational Qualification (OQ) of the CliniMACS Workbench to provide detailed, documented evidence according to GMP standards that the equipment operates according to Miltenyi Biotec’s specifications and customer requirements.
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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 Prodigy over time. Additional service contracts are available, providing features such as 24/7 clinical technical support and operational requalification of instruments when necessary.
