Controlling Access to Equipment in GMP Environment Using Beckman Coulter Tools

Bioproduction processes often rely on high-performance centrifuges and floor-standing ultracentrifuges. These instruments are run in Good Manufacturing Practice (GMP) environments and support GMP standards. The innovative features of the Avanti JXN and Optima XPN centrifuges support GMP compliance, while also significantly reducing the amount of administrative work that would be required with other systems.

User Management

It is critical to monitor access to equipment in a GMP setting. Password protection for up to 50 different user profiles is a key highlight of the Avanti JXN and the Optima XPN Series centrifuges.

Based on the permissions listed in table 1, it is possible to categorise users into three security levels including Administrator, Super User or Operator. Security levels enable managers to control the level of access each user has to the centrifuge.

Table 1. Permissions available on Optima XPN and Avanti JXN Series only

User Level

Permission

Administrator

Unlimited access.

Super User

Can run all programs, manage users, assign programs, and manage the rotor library.

Operator

Can run assigned programs and change user options.

Administrators can ensure log-in is required before anyone can use the centrifuge. The operator access can also be limited to pre-defined programs, thereby minimizing the potential for errors. For optimum security, the Avanti JXN and Optima XPN Series centrifuges provide the option of setting a PIN expiration date.

Avanti JXN-26 Centrifuge

Avanti JXN-26 Centrifuge

Data Logging

Detailed run tracking is available with the Avanti JXN and Optima XPN Series, enabling an archive to be built for each run. The archive can store the following information:

  • User information
  • Start date and time of the run
  • End date and time of the run
  • Rotor type
  • Program name
  • Acceleration and deceleration parameters
  • Before run comment
  • After run comment
  • Detailed information about each step in a run (speed, RCF, time, temp)
  • Any diagnostics that occurred during the run
  • Graph of the run (speed and temperature)
  • Electronic signature (if enabled)

It is possible to store and see this data on the centrifuge itself or it can be exported to a network drive, USB drive or a printer, so it can be archived. Using this powerful tracking ability, an audit trail of centrifuge activities can be maintained by enabling information from every run to be recorded and linked to particular user.

System Logging

The system log is a record of the dates and users responsible for each system option modified. The program log includes the history of changes made to a particular program run including the time, date and user responsible for each program modification.

Run Comments

In addition to the centrifuge run parameters, user comments that were entered before and after a run can be recorded in the run log history.

In the comment fields, any information that is relevant to the run can be stored, such as batch number, the name of the product being produced, anything unusual that happened during the run or any other relevant points about the run that would be useful for future reference. The Avanti JXN and the Optima XPN Series centrifuges also allow free-form comments to be added via the on-screen keyboard before and after the run.

Optima XPN Centrifuge

Optima XPN Centrifuge

Electronic Signature

An electronic signature capability is also offered by the Optima XPN and Avanti JXN Series centrifuges. On completion of a centrifuge run, it is possible to apply to the record an electronic signature that represents the run log’s author, reviewer or approver. The date, user name, instrument serial number and time stamp are included in the electronic signature, as well as any other notes entered when the signature was applied.

User-Defined Programs

Up to 1,000 user-defined programs consisting of up to 30 steps each can be set up in the Optima XPN and the Avanti JXN Series centrifuges, meaning almost any protocol can be entered and stored for future use. The program names can consist of up to 64 characters, in any combination of numbers, letters, or symbols, so meaningful names can be assigned that are easy to recall. Once established, the number of users who can access a protocol can be restricted because user-defined programs can be assigned to specific operators. These user-defined protocols help minimize the user error rate and ensure consistency between runs.

Real-Time Run Graphing

Real-time run graphing is available with the Optima XPN and Avanti JXN Series centrifuges, which enables the actual temperature and speed at the time of the centrifuge run to be plotted and stored in the run log for future reference. This run graph provides a way of visually tracking and recording the progress of the run so that any variation in temperature or speed can be quickly identified.

Rotor Tracking by Serial Number

The optima XPN and Avanti JXN Series centrifuges also enable users to monitor the number of cycles accumulated on particular rotors. Once established, an on-screen rotor library can be used to select rotors by serial number.

By tracking the number of cycles, the rotor life can be accurately monitored and retired if it becomes risky, unsafe or potentially damaging to the centrifuge. This detailed tracking information is also helpful to Beckman Coulter field service engineers carrying out rotor inspections as part of the Field Rotor Inspection Program (FRIP). These data can help ensure laboratory safety is maintained and instrument uptime maximized.

Remote Monitoring and Control

There is usually more than one centrifuge in bioproduction facilities. Using the remote monitoring and control capabilities of the Optima XPN and Avanti JXN Series centrifuges makes it easy to monitor a number of instruments.

Using Virtual Network Computing (VNC) software on PCs or the custom MobileFuge application for iOS and Android™ devices, the status of all instruments can be checked from almost anywhere. The VNC software enables users to operate the centrifuge from a PC, just as if they would if they were standing next to it. The MobileFuge mobile application allows remote monitoring of up to 16 centrifuges at any one time as well as enabling control of basic centrifuge functions from a mobile device. By allowing remote monitoring and control, these features enable the user to stay updated on the status of their centrifuges while also being free to proceed with and complete other tasks.

Email Diagnostic Alerts

In case there are any problems with a centrifuge, production managers can be informed via the email diagnostic alerts feature offered by the Optima XPN and Avanti JXN Series centrifuges. The email addresses to where such notifications must be sent are entered by the user and if any diagnostic issue occurs, a notification will be sent to all of the addresses listed. Irrespective of where the managers may be, they can be immediately notified of any issues with the centrifuge so that the appropriate course of action can be taken.

Conclusion

This article covers all the key features of the Avanti JXN and the Optima XPN series centrifuges in enabling control of equipment to support a GMP environment.

Trademarks are owned by the respective manufacturers mentioned.

Beckman Coulter, Optima, Avanti, and the stylized logo are trademarks of Beckman Coulter, Inc. and are registered with the USPTO.

About Beckman Coulter

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests. More than a quarter of a million Beckman Coulter instruments operate in laboratories around the world, supplying critical information for improving patient health and reducing the cost of care.


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Last updated: Mar 1, 2019 at 4:32 AM

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