WHAT WE DO: FERMENTATION
Matrix Technologies integrates stand-alone loop controllers, programmable logic controllers (PLCs) and distributed control systems (DCSs) to effectively monitor and control various fermentor parameters. Following are several project abstracts that detail how we have been successful in this service area.
MARKETED SUPPLY MANUFACTURING BIOREACTOR CONTROL SYSTEM UPGRADE
Matrix Technologies provided project management, engineering, documentation, installation, startup, validation, and training services for the main and auxiliary control systems upgrades on four bioreactors.
The existing single-loop controllers, switches, and displays were replaced with the Moore Products Procidia iPAC controller and iSTATION operator interface. The Procidia is a multi-loop modular controller with discrete and sequencing capabilities, specifically designed for systems that use more analog than discrete I/O.
Matrix was responsible for writing the functional specification, purchasing the hardware, fabricating the panels, developing the software, creating installation and operational qualification validation protocols, and performing a Factory Acceptance Test (FAT).
Upon completion of the installation, Matrix executed the validation protocols required by the FDA for new pharmaceutical manufacturing equipment.
MANUFACTURING FACILITY CONTROLS QUALIFICATION
Matrix Technologies developed and executed validation test procedures and test forms (TPs and TFs) for a newly constructed manufacturing facility. This project consisted of the following systems:
- Tangential Flow Filtration
- Deionized Water Skid and Loop
- Clean In Place
- Water For Injection Still and Loop
- Cold Room
- Pool Tank Monitoring Station
- Harvest Tank
- Heating, Ventilation, Air Conditioning
The client provided Matrix with engineering documents, which described the control system requirements, design and description. From these documents, Matrix generated the Automation Functional Specifications for each system. The validation Control Qualification (CQ) test procedures and forms were developed according to the Automation Functional Specifications and shaken down prior to execution. Matrix executed the validation protocols and wrote the CQ Summaries.
Matrix's responsibilities also included testing coordination, deviation reporting, tracking changes under change control, and retesting the system modifications. Matrix was also involved with the Validation Project Plan and the generation of SOPs and CQ templates.