Features

TruMigrations™

TruMigrations™ have been developed to harmonize and upgrade the installed base of older, proprietary bioreactor control systems. A TruMigration™ occurs when it is determined that an existing bioreactor control system is no longer able to meet the demands of the process.

TruMigrations™ seek to provide a cost-effective, easy-to-implement solution, wherein the user can retain existing process hardware, yet overlay the capability and features of TruBio™ software with the reliability and power of DeltaV-based control.

Features

TruBio™ IOQ

Finesse takes the guesswork out of validation by offering TruBio™ IOQ to complement its open, fully configurable TruBio™ operating system (TruBio™ OS). Upon completing TruBio™ IOQ, users will establish documented evidence assuring that TruBio™ OS meets all user requirements and design specifications. TruBio™ IOQ provides objective evidence that TruBio™ OS performs consistently and accurately per its intended use and user needs.

TruBio™ IOQ follows and incorporates established GAMP4 guidelines to ensure that TruBio™ OS is compliant with FDA’s Title 21 Code of Federal Regulations Parts 11, 210 and 211. TruBio™ IOQ also ensures that the TruBio™ OS will function as specified in cGMP and cGLP environments.

Features

Autoclave

SIP/CIP

Disposable

Perfusion

TruBio™ Bioprocess Control Software

The TruBio™ Bioprocess Control Operating System is an open, fully configurable, Commercial Off the Shelf (COTS) software solution that has been developed with GAMP4 methods and validated for cGMP applications. TruBio™ software is pre-configured with algorithms for controlling bioprocess parameters such as pH, dissolved oxygen, temperature, agitation, pressure, foam, level, gas/liquid flow, and weight, as well as supporting redundant sensor loops such as pH or dissolved oxygen. TruBio™ software has been optimized for DeltaV-enabled TruLogic™ Controllers.