The new mPath™ bioreactor control system
The new mPath™ bioreactor control system is an expandable control and data management system including both bioreactor control towers and an advanced supervisory control and data acquisition (SCADA) software package. Designed with a strong focus on ease of use, the system includes usability features such as biocontainer hangers with integrated load cells and mobile interfaces to modernize and simplify workflow. Features support characterization, optimization and compliance with GMP regulations providing a strong compliment to the Pall range of lab scale single-use bioreactors. The mPath bioreactor control systems are available with the XRS 25 bioreactor, with further lab scale bioreactors launching through the end of the year.
Process Control
- Sensors
All the connections you need.
- Flexible Control
Configurable control loops.
- Unique Features
Fluid and gas management.
Compliance / Safety
- User Safety
Human Factors Designed
- Pharmaceutical
GAMP V, 21 CFR Part 11
- Site / Electrical
IP54, CE, RoHS – designed & tested
Software / Connectivity
- No limits: Instruments, users, interfaces
- Secure database-centric design
- Strong support infrastructure
- Highly configurable
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Pall Link – Software Updates and Management
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Regular VersioningPall Link is an actively managed software package with a regular versioning schedule
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Validation ImpactVersions are web deployed with an outline of included features and a validation impact guide
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Service DeskAll feature requests and bug reports routed to LinkSupport@pall.com are managed through a Jira Service Desk
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Code ManagementSoftware updates are managed through GitHub, our secure online code management system
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GAMP5 ComplianceThis allows maximum traceability and effectiveness as well as GAMP5 compliance
Pall Link – Supervisory Control and Data Acquisition
Designed for enterprise-wide control and monitoring of bioreactor processes
Connect
Pall Link is a flexible bioprocess control software to connect your mPath bioreactor control towers.
- virtually plug & play setup of new bioreactors
- flexible control and recipe options
- multiple interface options
Full Integration
The software is supplied pre-loaded on a server which can be further configured by your IT team for full integration into the local network.
License Support
One license supports future updates within a master version, multiple bioreactors, and interfaces without additional hidden fees
Site and Network Integration
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Integrated Computer SystemsPall Link software and mPath bioreactor control towers are networked devices with integrated computer systems, allowing easy integration in local IT infrastructure
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Multiple LocationsWith IT support, users can access software from multiple locations
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RequirementsPall Link server may be installed in the lab or removed from the bioreactor depending on requirements
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Security SolutionsServer is designed to be configured with IT preferred security solutions including anti-virus software and network security packages which allows IT to more easily manage server over time
Safety
Through Compliance
mPath control towers are designed and tested to meet rigorous standards for environmental and electrical performance.
EMC Directive
2014/30/EU | BS EN 61326-1: 2013
Low Voltage Directive
2014/35/EU | BS EN 61010-1: 2010
Machinery Directive
2006/42/EC | BS EN ISO 12100:2010
RoHS Directive
All components RoHS compliant | (2011/65/EU)
IP Rating
Designed and tested - IP 54 | (IP54 IEC 60529)
Electrical data voltage
Universal Input: 100 – 240 V AC | Input Frequency: 50/60 Hz
Through Usability
- Unique biocontainer hangers weigh additions throughout the process while providing safe and stable support
- System exterior can be sprayed and wiped down with IPA alcohol to reduce bioburden
- Highly visible emergency stop button immediately ceases process functions during safety critical events
Regulatory Compliance
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Records RequirementsPall Link software and mPath bioreactor control towers are designed to meet pharmaceutical electronic records requirements - FDA 21 CFR Part 11 - EudraLex Annex 11
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Requirements and SecurityUsers can activate software features for signature requirements and data security
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Achieve ComplianceThese features, combined with site procedures, allow users to achieve compliance for cGMP cell culture processes