WHAT WE DO: FILLING & PACKAGING

FILLING & PACKAGING

Matrix Technologies control qualification services validate the performance of tasks including: vial washing, drying, handling and inspection of equipment, insertion of caps, lyophilization, and packaging bottles. Following are several project abstracts that detail how we have been successful in this service area.

CLINICAL PARENTERAL MANUFACTURING FACILITY

Matrix Technologies developed and executed validation test forms and test procedures (TF’s and TP’s), for a newly constructed parenteral manufacturing facility. This project consisted of the following systems:

During the system design and implementation stages, the client provided Matrix with engineering documents, which described the control system requirements, design and description. Matrix evaluated the system design and provided recommendations with regard to software and hardware documentation for the control system.

Matrix's responsibilities also included testing coordination, deviation reporting, tracking changes under change control, and retesting the system modifications.

LYOPHILIZER CONTROL SYSTEM QUALIFICATION PROJECT

Matrix Technologies developed and executed validation test forms and test procedures (TF’s and TP’s), for a newly installed BOC Edwards Lyophilizer 56 and its associated components and utilities. This project consisted of the following systems:

During the system design and implementation stages, client provided Matrix with engineering documents, which described the control system requirements, design and description. Matrix evaluated the system design and provided recommendations with regard to software and hardware documentation for the control system.

Matrix's responsibilities also included testing coordination, deviation reporting, tracking changes under change control, and retesting the system modifications.

FILLER/CAPPER MODIFICATION PROJECT

Matrix Technologies provided the management and engineering/validation services for a modified filling system and its related equipment.

Matrix performed control systems modifications of the capping machine to meet system requirements. Matrix also performed major re-design of the Hurst Tray Loading machine software used in conjunction with the Capper. The tray loader modifications involved programming the controller to adjust the speed during tray switching. After all modifications were designed and developed a Software Test Plan (STP) was generated to validate proper and expected system performance. Matrix provided the modified software along with comprehensive supporting documentation.

The process control system includes an Allen-Bradley PLC 5/20, Micrologix 1500 and Allen-Bradley PanelView 300 Human-Machine Interface.

FILL LINE CONTROL QUALIFICATION PROJECT

The scope of this project included the generation/modification of design documents and the control system qualification (CQ) for Fill Line equipment.

The equipment validated consisted of an ultrasonic washer, two Steris autoclaves, an IMA vial washer and drying tunnel, a Bosch filler, two vial cappers and two tray loaders. Protocol development and execution for CQ of the building’s Environmental Monitoring System (EMS) were also completed as part of this project.

Each system consisted of an Allen-Bradley ControlLogix PLC programmed using RSLogix 5000. The Bosch Filler and the EMS systems utilized Intellution iFix software. The remaining systems used either a PanelView 700 or 1000 Human Machine Interface (HMI) program utilizing Rockwell’s RSLinx communication software.

The goal of this project was to validate, within an aggressive project schedule, the operation of the integrated fill line equipment that is used for aseptic filling operations. The documentation reviewed and updated included the Automation Functional Specification (AFS), the Hardware Design Specification (HDS), the Software Design Specification (SDS) and the Software Module Design Specification (SMDS).

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

PARENTERAL MANUFACTURING EXPANSION

Matrix Technologies developed and executed computer control system validation protocols, for a newly constructed parenteral manufacturing facility. This project consisted of the following systems:

During the system design and implementation stages, the client provided Matrix with engineering documents, which described the control system requirements, design and description. Matrix evaluated the system design and provided recommendations with regard to software and hardware documentation for the control system.

Matrix's responsibilities also included testing coordination, deviation reporting and tracking changes under change control and retesting the system modifications.