WHAT WE DO: UTILITIES

UTILITIES

Any utility that can affect a product’s quality must be designed, built and qualified under current Good Manufacturing Practices (cGMP). Common utilities designed and validated by Matrix Technologies using cGMP include: water systems––Purified Water (PW), Deionized Water (DIW), and Water for Injection (WFI); clean steam; nitrogen; CO2; HVAC; Clean in Place (CIP); Steam in Place (SIP); and autoclaves. Following are several project abstracts that detail how we have been successful in this service area.

BUILDING AUTOMATION SYSTEM QUALIFICATION PROJECT

The project effort validated, within an extremely aggressive time frame, the operation of the Building Automation System (BAS) serving both unclassified and critically classified spaces within a client facility. Vendor protocols for the testing of the BAS Cabinets, Human Machine Interface (HMI) Graphics, and the BAS Network were modified to bring them in line with project standards. Protocol shake down occurred in conjunction with system startup, and executed in a phased manner to meet construction and operational restrictions.

The BAS, consists of six Air Handling Units and four Variable Frequency Drive Cabinets.  Each VFD cabinet contains up to 20 individual drives.

Each AHU and VFD cabinet was controlled by an Allen-Bradley CompactLogix PLC programmed using RSLogix 5000. All systems utilized Intellution iFix software for interface, communication, alarming and data historian services. These services were accessed via client HMI terminals.

Design documentation and system frame protocol modifications were made to support the project timeline. Limited commissioning and troubleshooting was performed in support of the system testing.

The validation test procedures and forms were executed per client’s Standard Operation Procedure (SOP) and applicable project standards.

STERIS FINN-AQUA AUTOCLAVE CONTROL QUALIFICATION PROJECT

The scope of this project included project management, generation, and execution of Control Qualification (CQ) Test Procedures and Test Forms (TP/TFs) for a Clinical Parenteral Manufacturing Facility Steris Finn-Aqua Autoclave.

The Autoclave was designed for steam sterilization of various types of dry good products such as glassware, rubber stoppers, filter housings and cartridges, machine parts, textiles, etc.  The control system also includes cycles required for autoclave filter sterilization and leak rate testing.

The equipment validated consisted of a Finn-Aqua GMP Sterilizer (9912-D-B-GMP-ABS5), an Allen Bradley SLC500 5/05 Programmable Logic Controller (PLC), a PanelView 1000 non-sterile side Human Machine Interface (HMI), a PanelView 500 sterile side HMI, chart recorder, and printer.  PLC communication to the HMIs was via Ethernet utilizing Rockwell’s RSLinx communication software.

The goal of the Steris Finn-Aqua Autoclave CQ project was to validate the automated control hardware, software functions and sequences as required by the system documentation.  CQ TP/TFs were generated based on panel layout drawings, electrical drawings, a Hardware Design Description (HDD), and a combined Automation Functional Requirements and Software Design Description (AFR/SDD).

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