The following are some of the representative projects AIV engineers have executed in the biotech and pharmaceutical industry:

Cell Culture Pilot Plant

This facility was constructed to provide support for production of needed phase I and II supplies for several promising therapeutic monoclonal antibodies. The facility consisted of two (2) 250L bioreactors and a new Purified Water System.

Control system architecture utilized the Emerson Performance Systems' DeltaV Distributed Control System, which consisted of three (3) MD controllers and three (3) Daisy Data flat panel displays with near-Infrared (NIR) touch screens. Architecture also included one (1) Batch Executive server and one (1) Web server.

To design and implement the above system, AIV Solutions engineers performed the following services:

  • Developed Functional Specification (FS) documents to capture all client requirements.
  • Developed Software Design Documents (SDD) for the application software to be written for the control system. Software design utilized a modular approach.
  • Developed custom software modules (e.g., DO and pH control, F0 calculation, and Equipment status monitoring) and custom graphic dynamos
  • Developed source code (control modules, interlocks, operator graphics, phase logic modules and complete recipe structure) for the control system. Developed in-house utilities for controller I/O and control module configuration import into the control system database to increase efficiency and consistency of source code development.
  • Implemented the Continuous Historian, Batch Historian, Batch Executive, and Web Server software packages.
  • Performed software reviews at each stage of development using in-house reporting tools for controller, control module and advanced definitions configuration.
  • Performed in-house de-bug testing.
  • Developed software acceptance test documents for use at Factory Acceptance and well as Site Acceptance testing.
  • Performed installation, checkout, and start-up.

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Cell Culture Manufacturing Facility

This facility consisted of forty cell culture bioreactors in three production suites.

Control system architecture consisted of fourteen (14) Allen-Bradley PLC5/80, and forty (40) XYCOM Model 9014 HMI stations and twenty (20) Windows NT SCADA workstations running Wonderware InTouch. Architecture also included two InBatch servers and two industrial SQL servers.

To design and implement the above system, we performed the following services:

  • Defined the requirements for desired mode of operation.
  • Developed General Design documents to capture all client requirements
  • Developed software design documents for the application software to be written for the control system. Software design utilized a modular approach. Software modules were specified for basic functions such as:
  • Modifying control parameters (i.e., setpoints, control modes, alarm limits, etc.),
  • Typical operations (CIP, SIP, etc.)
  • Data logging to and industrial SQL server (Historical, Event, Alarms), etc.
  • Developed source code (PLC ladder logic, continuous control loops, graphic displays, sequence scripts, reports) for the control system.
  • Performed software reviews at each stage of development.
  • Developed software acceptance test documents for use at Factory Acceptance and well as Site Acceptance testing.
  • Performed installation, check-out, and start-up.

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Fermentation / Purification Facility

This project involved renovation of an existing facility for the production of a recombinant protein derived from a microbial source.

Fermentation is initiated in a two-stage seed culture followed by a 1200L fed-batch fermentation. In addition to fermentation, unit operations include centrifugation, high-pressure homogenization, buffer preparation, solubilization, modification, harvest, ultrafiltration, purification, CIP, SIP, WFI, and WPU.

An existing ABB ADVANT for MOD300 DCS with batch management functionality was expanded to perform automated CIP, SIP, and batch production operations.

To design and implement the above system, we performed the following services:

  • Interviewed operating and process development personnel to understand client's existing practices and standards.
  • Developed User Requirements specifications to capture all of the client's requirements.
  • Developed Detailed Design Specifications for the application software to be configured for the control system. Software design used a modular approach to maximize reuse of code. The Process Model, which includes the procedural control model and the physical model, were identified as per ISA-S88.01. Units and control modules were listed for equipment. Procedures, unit procedures, operations, and phases were identified for the process.
  • Developed source code (continuous control loops, interlock logic, graphic displays, phases, batch recipes, PLC interfaces) for the control system.
  • Performed periodic software audits and reviews at each stage of development.
  • Developed software acceptance test documents for use at Factory Acceptance testing.

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Validation of Web-Based Applications

Client provides a customized WEB-based application to track distribution of pharmaceutical materials for use in clinical trials. The Internet application is a secured Web Server that uses Windows NT challenge response security and Secured Socket Layer (SSL) technologies. The WEB application involves programming Active Server Page (ASP) and SQL Server to tracks patient and clinical trial kits.

AIV Solutions generated and executed test protocols to validate each client application and database transactions. Client custom applications include the use of ASP scripts, JAVA scripts, Microsoft VBA, Lotus Notes, SQL Server and Oracle.

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Stability Chamber Validation Project

Client's Stability Chamber Monitoring System monitors and provides historical logging of temperature and humidity for 9 Stability Chambers. The Stability Chamber Monitoring System contains a BlackBox RS485 ISA card to provide communications to the field devices via the MODBUS protocol. Wonderware InTouch monitors these field devices and provides the data to SQL Server, Win 911 alarm dialout software, and Seagate Crystal Reports.

AIV Solutions generated and executed Installation and Operational Qualification protocol to validate client's Stability Chamber Monitoring System.

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