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Talecris Biotherapeutics

Crosstec has been involved at Talecris since its inception in 2004. We currently maintain an on-site team at their Clayton, North Carolina facility.

To date, Crosstec has been able to help Talecris with projects involving:

  • DEAE Column Skid Automation
  • Clarification Process Automation
    • Precipitation Processing
    • Centrifugation
  • Increasing capacity of Existing Processes
  • AutoClave PLC connectivity to DCS for Monitoring and Reporting
  • Custom Reporting for existing processes

Hardware:

  • ABB Advant and SC Controllers DCS
  • Allen-Bradley SLC500 Series PLCs

Software Process Design and Programming:

  • ABB Advant / MOD300
  • RSLogix 500
  • Oracle Reports

Automated Systems:

  • Column Skids
  • Centrifugation Systems
  • AutoClaves

FDA / GMP Documentation:

  • User Requirements Specifications (URS)
  • System Design Descriptions (SDD)
  • Traceability Matrixes
  • Validation Plans
  • Validation Protocols (IQ/OQ)

Bayer Biological Products

Crosstec was involved at the Bayer Biological Products facility in Clayton, North Carolina during 2004 (prior to its transition into Talecris Biotherapeutics).

Projects for Bayer included:

  • Plasma processing systems
  • Clean In Place improvements for existing processes
  • Custom Reporting for existing Processes

Hardware:

  • ABB Advant Controllers DCS

Software Process Design and Programming:

  • ABB Advant / MOD300
  • Oracle Reports

FDA / GMP Documentation:

  • System Design Descriptions (SDD)
  • Traceability Matrixes
  • Validation Plans
  • Validation Protocols (IQ/OQ)

Wyeth

Crosstec's 18 month stay at Wyeth's facility in Sanford, NC has given us the opportunity to provide valuable services to their Manufacturing and Engineering teams on both their Fermentation SCADA and New Manufacturing Module projects.

Our on-site team focused on the following:

  • Automation Review of DeltaV System
  • Automation Lead for CIP system review
  • DeltaV Batch Recipe Designs (based on the S88 Standard)
  • Generation of Batch Recipe Detailed Design Specifications
  • DeltaV Batch Reporting User Requirements Specifications

Additionally, in order to aid in the generation of the Batch Recipe Detail Design Specifications, Crosstec created a software utility called SpecGen for DeltaV that organizes and links the S88 structure of the Recipes and produces S88 style output of both the recipe architecture and parameter values. Over 3,000 pages of documentation have been generated at Wyeth with the help of this tool. Whereas a minor change to the recipe design (along with the propagation that the S88 standard would necessitate) could take hours to correct and review by hand, the entire specification can now be reconciled and regenerated in a matter of minutes.

Hardware:

  • Emerson DeltaV
  • Allen-Bradley SLC500 PLC's (SLC5/04 CPU's)

Software Process Design and Programming:

  • Emerson DeltaV
  • RSLogix 500
  • WonderWare FactorySuite
  • Microsoft Access

Automated Systems:

  • Fermentors
  • Clean-In-Place (CIP)
  • Clean Utilities
  • Centrifugation Systems
  • Micro and Ultra Filtration
  • Liquid Chromatography

FDA / GMP Documentation:

  • Functional Requirements
  • Design Specifications

Diosynth

Crosstec has been involved at Diosynth's facility in Research Triangle Park, NC since their appearance on the scene in the summer of 2001. In fact, we've been involved in most of the projects that have occurred since Diosynth assumed ownership of the site.

Major projects with Diosynth have included:

  • Programming/implementation of web-based Batch and Continuous system reporting communicating directly with the ABB Advant Historians.
  • Design and implementation of the Automation/Controls communication network, which integrated both MS Windows and Unix-based workstations and servers, allowing for the secure and efficient control of critical data and communications to and from the ABB Advant DCS.
  • Implemented a re-worked strategy for the Pichia Induction Process for the Fermentation area, including startup and commissioning as well as the associated documentation required.
  • Provided services for the Buffer Area control project, including engineering database programming, operator graphic and environment design, and the associated turn-over documentation

Hardware:

  • Automation Control Intranet Network
  • ABB Advant DCS
  • Allen-Bradley SLC500 PLC's (SLC5/04 CPU's)

Software:

  • ABB MOD 300
  • RSLogix 500
  • Linux - Apache web server, PostgreSQL RDBMS, Perl/CGI

Systems:

  • Web-based DCS Batch Reporting System
  • Fermentors and Bioreactor Systems
  • Pichia Induction Process
  • Clean-In-Place (CIP)

FDA / GMP Documentation:

  • Standards
  • Functional Requirements Specifications (FRS)
  • System Design Descriptions

Covance Bio

Prior to Diosynth's purchase of this RTP based facility, the site was owned and operated by Covance Biotechnology Services, Inc. Crosstec worked closely with Covance Engineering from 1998 to 2001.

Projects

Crosstec had the opportunity to be heavily involved in Covance's Fermentation and Refold Expansion projects, playing a major role in the startup and commissioning of both. For Refold we were Automation Project leads, our main objective being the startup of a new ABB Advant Control Subsystem.

Clean in Place

In addition to the expansion projects, a great deal of CIP programming (both on the PLC as well as CIP skid integration with the ABB Advant DCS) was performed by our team. We also implemented an extensive re-working of the DCS to PLC communication strategy including its design and successful implementation.

Utilities

Crosstec performed maintenance and upgrade activities on the PLC-based utility systems at Covance and provided services to integrate these systems into the ABB Advant DCS.

Documentation

For each project or system, Crosstec provided all required FDA-level documentation at project turn-over, including Functional Requirements, Detailed Design Specifications, and SOP's.

Hardware:

  • ABB Advant DCS
  • Allen-Bradley SLC500 PLC's (SLC5/04 CPU's)

Software:

  • ABB MOD 300
  • RSLogix 500
  • Oracle RDBMS 7.x

Systems:

  • Fermentors and Bioreactors
  • Clean-In-Place (CIP)
  • Steam-In-Place (SIP)
  • Clean Utilities
    • Water Purification Unit (WPU)
    • Water For Injection (WFI)
    • Pure Steam Generation (PSG)
  • Centrifugation Systems
  • Micro and Ultra Filtration
  • Liquid Chromatography

FDA / GMP Documentation:

  • Standards
  • Functional Requirements Specifications (FRS)
  • System Design Descriptions