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Clinical Diagnostics Manufacturing

Superior Controls implemented a $2.5M Capacity Expansion Process Control System (PCS) as part of the Siemens Medical Solutions $100M Building Expansion at their state-of-the-art Manufacturing Facility in Walpole, Massachusetts. This 115,000 sq.ft. facility expansion nearly doubled production capacity, enabling the annual production of over one billion diagnostic tests, for the leading clinical diagnostics company in the world, offering the most comprehensive portfolio of products and solutions used to diagnose, treat and monitor patients around the globe.

The PCS provides process control, monitoring, and automation management of wetcake diagnostic manufacturing. The PCS is based on PLC architecture using Allen-Bradley ControlLogix processors with multiple processors and distributed I/O, and includes integrated Supervisory Control and Data Acquisition (SCADA) servers, workstations, Strongarm OITs, and wireless Tablet PCs with barcode readers.

The PLCs communicate over Ethernet to 2 server computers running GE Proficy iFIX SCADA software and 2 other servers running GE Proficy Batch Execution software.

Multiple PLCs control and interface to the following process areas:

  • Buffer Prep
  • Ethanol Distribution
  • Buffer Prep Pit Scales
  • Special Waste Collection
  • CIP
  • Material Kitting
  • Dilution
  • PCS
  • DI/RO Water Distribution
  • WMS

The PLCs communicate over ControlNet to the following process and utility equipment that are provided as OEM packages complete with their own control systems:

  • CIP System
  • Waste Treatment
  • DI Water Systems 1 & 2
  • WMS Temperature Control Unit
  • RO Water System

The following briefly describes the process areas controlled by and interfaced to the PCS:

  • Material Kitting: Material Kitting is used to retrieve material data from a material database, control and record the weighing operations, produce a material barcode, and provide an operator interface to the Material Kitting function. Material Kitting is used to manage the flow of material data to and from scales located in the Downflow Booths, Vented Balance Enclosures, Open Benchtop Scales, and Fume Hood Scales. Material requirements for each recipe are calculated by the PCS when a recipe is loaded. The PCS prompts the operator to scan the barcode of the required material prior to introduction to the process. The barcode label printed by the PCS contains material information including hazard information, storage requirements, and expiration date.
  • Buffer Prep: The Buffer Prep area provides formulation buffer for the final reagents. The Buffer Prep Room contains two 6,000L Buffer Prep Tanks, Laminar Flow Booth for material sub-division, Fume Hood, Isolation Box and Transfer/Recirculation pumps.
    Buffer Prep Pit Scales: The Buffer Prep Pit Scales include two Pit Scales for mixing small-batch buffers and other solutions as intermediate products used in the WMS-1 and the Chromatography areas.
  • Dilution: The Dilution system allows for preparation and storage of the final reagents prior to filling. The dilution room contains six 5,000L dilution tanks, with several transfer panels and manifolds to direct flow of product and Clean-In-Place (CIP) fluid to/from each tank.
  • WMS-1 Area: The WMS-1 system provides wetcake used for the production of Solid Phase Dilution. The WMS-1 system consists of a 150L Product Reactor, 3 Magnetic Separators, 6 Buffer/Wash Tanks, a Temperature Control Unit, along with several transfer panels and manifolds to direct flow of product and Clean-In-Place (CIP) fluid to/from each tank.
  • CIP System: The CIP System cleans, drains, and dries the process equipment, the supply and return piping, and the transfer lines between process areas. The CIP System is comprised of two vendor-supplied, self-contained skids. The CIP Skid contains dual CIP return pumps, a 300 gallon DI water tank, a 500 gallon CIP wash tank, two CIP supply pumps, a UV light, a DI Water Recirculation pump, filters, and a shell & tube heat exchanger. An additional skid contains the drying air blower and filters. The system also includes acid and caustic addition pumps, distribution valves, and several transfer panels and manifolds to direct the flow of CIP fluid to/from each tank and path.
  • RO Water System: The RO Water treatment system is a vendor-supplied, skid-mounted system. It fills a pair of RO Water Break Tanks which supplies a pumped RO Loop for Buildings 3 and 4. The RO Water Loop supplies the four DI Water Loops in two buildings.
  • DI Water System: The two DI Water systems are vendor-supplied, skid-mounted systems. Each of the systems are comprised of 2500 Gal DI Water Break Tanks, a booster pump skid, a set of three mixed bed columns, a distribution pump skid, and an RO Water polishing skid with a UV light and dual 0.2u filters. The PCS is used for control of the DI Water Tanks fill valves and DI/RO Water distribution valves.
  • Ethanol Distribution: The Ethanol Distribution system allows for automated dispensing of Ethanol into the containers/vessels needed for the chromatography equipment. Ethanol is supplied to the Chromatography operations via an automated distribution system. There is a use point(s) located in both the Lite Reagent and Purification areas of Building 4. Ethanol is procured from specialized totes, which are connected to a pumped header system. The user activates the Ethanol Distribution system to dispense the Ethanol into the appropriate container/vessel.
  • Waste Treatment: The Special Waste Collection header allows for a direct discharge of Special Wastes to a collection tote. Waste streams generated by the chromatography process are diverted to a collection tote. A secondary waste stream from the WMS-1 system is also collected in the waste tote.

The PCS included 150+ hardwired points, 1100+ DeviceNet points, and 10 ControlNet drops. The system featured 25 PID loops, 200+ datalogged points, and over 5000 setpoints.

The PCS computer system includes the following:

  • 2 SCADA Servers
  • 2 Engineering Workstations
  • 2 S88 Batch Servers
  • 11 Strongarm Mini Consoles
  • 1 Data Historian Server
  • 4 PanelView 600
  • 1 Domain Controller Server
  • 5 Tablet PCs

The server computers communicate over Ethernet to a single server computer running GE Proficy Historian and Microsoft SQL Server software which function as the data historian to the system. The Proficy Historian database is configured to record process data. In addition, the SQL Server database is configured to capture batch data, alarms, and events. The 2 engineering workstations are configured with full development capabilities for the Proficy iFIX and Batch configurations.

Four Allen-Bradley PanelView 600 Operator Interface Terminals (OITs) communicate over ControlNet to the PLCs for local control in the Ethanol, Waste Handling, Purification, and Reagent Areas.

Multiple Strongarm and wall station console computers are configured with GE Fanuc Proficy iClient software, to act as operator interfaces to the PCS.

Tablet PCs communicate over wireless Ethernet to provide mobile SCADA functions/data entry close to the process areas. Data entry includes operator acknowledgement of prompts and data entry using barcode scanners.

Communications include ControlNet for communication between the ControlLogix PLCs, communication between the ControlLogix PLCs and the various Remote I/O Panels, and for communication between the ControlLogix PLCs and the CN2DN linking devices to the corresponding DeviceNet segments; Ethernet is used for communication between the PCS servers, PCS PLCs and OITs; Wireless Ethernet is used for communication to the Tablet PCs; DeviceNet is used for communication to VFDs and most automatic valves.

The Batch servers provide batch monitoring and control, recipe development and management; and batch alarm and event logging. The Batch servers provide system administration activities including backup and recovery operations.

The Data Historian server provides historical and batch record data collection, data storage; Historian Batch reports are accessed for local viewing and printing from the OITs. A batch report is selected from a list of batch IDs. The batch report is created using Crystal Reports from information stored throughout the execution of the batch in the SQL database on the Historian Server.

Batch reports includes 4 sections:

  • The header section contains batch ID, product name, product revision, recipe IDs, recipe revisions, recipe size, batch start and completion time/date, recipe start and completion times/dates.
  • The data section contains process data associated with the execution of each phase as required for the batch report as required by the associated phase.
  • The alarm section lists all batch related critical alarms along with time of occurrence, tagname and description.
  • The event section lists all manual interventions from event logging that were performed during the batch.

The following project documents and services were provided by Superior Controls:

  • Quality and Project Plan (QPP)
  • Functional Specification (FS) for each process area
  • I/O List
  • Alarm List for each process area
  • Setpoint List for each process area
  • Hardware Design Specification (HDS) for each process area
  • Software Module Design Specification (SMDS) for each phase, equipment module, and control module (99 total)
  • Electrical Drawings for server and Ethernet network cabinets
  • Controller hardware configuration, architecture and programming
  • Operator interface configuration, architecture, and programming
  • Factory Acceptance Test (FAT) protocol for each of the following vendor supplied skids: Buffer Prep, Dilution, and WMS-1
  • Factory Acceptance Test (FAT) execution
  • Factory Acceptance Test (FAT) Report
  • Hardware Factory Acceptance Test (HFAT) protocol for each of the following vendor supplied hardware: Control Panel and¬†Computer & Peripheral Devices
  • Hardware Factory Acceptance Test (HFAT) execution
  • Hardware Factory Acceptance Test (HFAT) Report
  • Software Factory Acceptance Test (SFAT) protocol for each of the following process areas: Buffer Prep, CIP, Control Modules, Dilution, DI/RO Water Distribution, Utilities, and WMS-1
  • Software Factory Acceptance Test (SFAT) execution
  • Software Factory Acceptance Test (SFAT) Report
  • Start-up assistance
  • Site Acceptance Test (SAT) protocol for each of the following process areas: Buffer Prep and Pit Scales, CIP, Dilution, DI/RO¬†Water Distribution, Material Kitting, Utilities, and WMS-1
  • Site Acceptance Test (SAT) execution
  • Site Acceptance Test (SAT) Report
  • Traceability Matrix (TM)
  • Disaster Recovery Plan (DRP)
  • Operation Manuals for the General Operations of the PCS, Batch Operations, Material Kitting, and Creation & Maintenance of Recipes
  • Final Documentation

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