Get Control in GMP Environments

Floor-standing ultracentrifuges and high-performance centrifuges are vital to many bioproduction  processes. Instruments are run in Good Manufacturing Practice (GMP) environments, and must support compliance with these regulations. Innovative features built into Optima XPN and Avanti JXN Series centrifuges support GMP compliance while eliminating much of the administrative work of other systems.

By Beckman Coulter Life Sciences

Centrifugation that supports compliance and eliminates hassle.

User Management

Controlling access to equipment within a GMP environment is critical. The Optima XPN and Avanti JXN Series centrifuges feature password protection for up to 50 unique user profiles. Users can be classified by one of three available security levels—Administrator, Super User, or Operator. Security levels provide the ability to control the level of access each user has to the centrifuge based on their permissions.

Data Logging

The Optima XPN and Avanti JXN Series allow for detailed run tracking that builds and stores an archive of each run. In addition to the standard centrifuge run parameters, it is possible to capture user comments entered before or after a run in the run log history. These comment fields can include batch numbers, the name of the product being produced, or anything else related to the run that would be useful to store in the log for future reference.

Electronic Signature

In addition to capturing and storing run data, the Optima XPN and Avanti JXN Series centrifuges also offer electronic signature capability. The electronic signature includes the user’s name, date and time stamp, the instrument serial number, and any notes that were entered at the time of signature.

User-Defined Programs

The Optima XPN and Avanti JXN Series centrifuges allow up to 1,000 user-defined programs consisting of up to 30 steps each, ensuring that virtually any protocol can be set up and stored for future use. Once established, user-defined programs can be assigned to specific operators, limiting the number of users with access to the protocol.

Rotor Tracking by Serial Number

The Optima XPN and Avanti JXN Series centrifuges are also able to track the number of cycles accumulated on specific rotors. Once set up, users can choose rotors by serial number from an onscreen rotor library. The centrifuge tracks the number of cycles, so the life of the rotor can be precisely tracked and retired before it becomes unsafe. \

Remote Monitoring and Control

The remote monitoring and control capabilities of the Optima XPN and Avanti JXN Series centrifuges make monitoring multiple instruments easy. Users can check the status of all instruments from virtually anywhere via personal computer using Virtual Network Computing (VNC) software, or mobile device using the custom MobileFuge application available for iOS and Android™ devices. The VNC software allows users to operate the centrifuge from a PC just as if they were standing in front of it.

Email Diagnostic Alerts

Using the email diagnostic alerts feature on the Optima XPN and Avanti JXN Series centrifuges, production managers can be notified whenever there is an issue with a centrifuge. Users enter the email address(es) where the notifications will be sent, then if a diagnostic issue occurs, the centrifuge will send a notification to everyone on the list alerting them to the problem.


Categories: Products in Action

Published In

Changing The Rules Magazine Issue Cover
Changing The Rules

Published: March 12, 2015

Cover Story

Changing the Rules

It has been over 40 months since President Obama signed the Leahy-Smith America Invents Act (AIA) into law in September 2011, climaxing years of feverish legislative wrangling. AIA was heralded as a game-changer, the dawning of an equitable intellectual property (IP) regimen that rewarded research scientists and innovators beset by ineffectual patent processes and procedures.

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