WHAT WE DO: RECOVERY

RECOVERY

Experts in ISA S88 batching standards, Matrix Technologies designs software that is more robust, easier to maintain and provides more reliable results than standard programming methods. Following are several project abstracts that detail how we have been successful in this service area.

CHO CENTRIFUGE CIP SKID QUALIFICATION PROJECT

The scope of this project included the review of design documents and the generation/modification of the control system qualification (CQ) for the new Chinese Hamster Ovary (CHO) Centrifuge CIP (Clean-In-Place).

The equipment validated consisted of a CIP tank and associated piping used to clean two centrifuge systems. The centrifuge systems are used during the production process to separate cells/cell fragments and precipitates from a fermented or prepared medium.  The equipment also provided CIP tank sanitization and centrifuge flushing capabilities.

The system consists of an Allen-Bradley ControlLogix PLC programmed using RSLogix 5000 and an Allen-Bradley PanelView 1000 HMI display. Communication utilizes Rockwell’s RSLinx communication software.

The goal of the CHO CIP CQ project was to validate the automated control functions and sequences as required by the system documentation. The documentation reviewed and updated included the Automation Functional Requirements and Software Design Description (AFR/SDD) and the Hardware Design Description (HDD).

Upon approval of the CQ documentation, Matrix Technologies executed the control system validation protocol in compliance with the client’s Standard Operating Procedures.

CHROMATOGRAPHY SKID CONTROL QUALIFICATION PROJECT

The scope of this project included the review of design documents and the generation/modification of the control system qualification (CQ) for a new chromatography skid in our client’s manufacturing facility.

The equipment validated is utilized as a purification stage for the clinical production of multiple products on a campaigned basis. The system is designed to separate desired proteins from contaminant proteins and other macromolecules within the product pool when used in conjunction with the appropriate chromatography column.

The system consists of an Allen-Bradley 5/80E PLC programmed using Allen-Bradley’s PLC-5 programming software.  The Human Machine Interface is an Allen-Bradley AB6180 industrial computer (Pentium-based PC). The HMI was developed using RSView32.  Communication utilizes Rockwell’s RSLinx communication software.

The goal of the CQ project was to validate the automated control functions and sequences as required by the system documentation. The documentation reviewed and updated included the Automation Functional Requirements (AFR), Software Design Description (SDD) and the Hardware Design Description (HDD).

Upon approval of the CQ documentation, Matrix Technologies executed the control system validation protocol in compliance with our client’s Standard Operating Procedures.