mPath Lab Scale Bioreactor Control

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

  • Regular Versioning
    Pall Link is an actively managed software package with a regular versioning schedule
  • Validation Impact
    Versions are web deployed with an outline of included features and a validation impact guide
  • Service Desk
    All feature requests and bug reports routed to LinkSupport@pall.com are managed through a Jira Service Desk
  • Code Management
    Software updates are managed through GitHub, our secure online code management system
  • GAMP5 Compliance
    This 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

Process Control

Pall mPath bioreactor control system optimizes each element to provide the most flexible and stable process control at this scale. Effective process control is the combination of these three core elements

Sensors
Logic
Output
Touchscreen on Tower

Touchscreen on Tower

  • Small / flat HDMI Touchscreen
  • HDMI cable
  • Similar functionality can be achieved with a mobile tablet
Touchscreen on Tower
Touchscreen Near Tower

Touchscreen Near Tower

  • Freestanding HDMI Touchscreen
  • HDMI cable
Touchscreen Near Tower
Touchscreen Near Server

Touchscreen Near Server

  • Freestanding HDMI Touchscreen
  • HDMI cable
Touchscreen Near Server
Wifi Devices

Wifi Devices

  • WiFi router
  • Laptops, tablets, mobile phones

Tablets can be docked on tower for local interface

Wifi Devices
Laboratory & Office Workstations

Laboratory & Office Workstations

  • Connection to Pall Link network
  • Desktop or laptop computer
Laboratory & Office Workstations
Remote Mobile Devices

Remote Mobile Devices

  • Pall Link network exposed for external access
  • Laptops, tablets, mobile phones
Remote Mobile Devices

Pall Link

Multiple Network Options

1:1

1 : Many

Site and Network Integration

  • Integrated Computer Systems
    Pall Link software and mPath bioreactor control towers are networked devices with integrated computer systems, allowing easy integration in local IT infrastructure
  • Multiple Locations
    With IT support, users can access software from multiple locations
  • Requirements
    Pall Link server may be installed in the lab or removed from the bioreactor depending on requirements
  • Security Solutions
    Server 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

Ready for process development and small scale manufacturing processes
  • Records Requirements
    Pall Link software and mPath bioreactor control towers are designed to meet pharmaceutical electronic records requirements - FDA 21 CFR Part 11 - EudraLex Annex 11
  • Requirements and Security
    Users can activate software features for signature requirements and data security
  • Achieve Compliance
    These features, combined with site procedures, allow users to achieve compliance for cGMP cell culture processes