Project Experience

RoviSys has been working with many of the world’s leading pharmaceutical and biotechnology Companies for more than a decade. These clients have asked us to perform every aspect of automation project. We have successfully implemented small and large projects with the same focus on results that has fueled our growth and encouraged long-term relationships with our customers.

Some of our larger pharmaceutical projects have exceeded $3 million dollars in engineering scope with more than 30,000 value-added engineering hours. We have been responsible for every engineering task required to define, implement, validate and startup a validated control system, including:

Creation of User Requirement Specifications
Creation of the validation documents required for the System Development Life Cycle (SDLC) Activities.
System engineering to implement the control philosophies for basic control with interlocks and complex batch control.
Training in the procedures required for validation testing and sign-offs.
Validation execution and signing of validation documents.
Training on audit interfacing with the FDA
Post-FDA audit punch list resolution

Recent project work is listed below. For more information on RoviSys pharmaceutical and biotechnology project case histories, contact John Turk or John Hall at 440-562-8600.:

Batch Retorts–DCS, PLC skid system, OPC, RFID Tracking

RoviSys was the lead integrator for a Batch Retort Furnace project. This project involves seven batch retorts using a distributed control platform. Product is shuttled into these furnaces via a PLC skid system that interfaces with the DCS via an OPC connection. Barcode readers communicating via DeviceNet at 12 locations identify where the shuttle baskets are and confirm delivery of the proper basket to the proper destination. The I/O count for this system is approximately 1,000 points. Our scope of work includes all of the design, implementation, validation documentation, validation execution and post-FDA audit resolution. We are also responsible for the supervision of the OEM’s skid-mounted equipment and interfacing with the material management system via a redundant OPC connection.

Drug Manufacturing–DCS, Fieldbus, DeviceNet

RoviSys was the lead integrator in the system engineering for this large-scale drug manufacturing project. Our complex batch DCS configuration controlled the process in the regeneration, harvest and isolation areas. A significant portion of the code dealt with the arbitration of a shared CIP/SIP skid package. The I/O counts totaled approximately 2,500 points and the engineering hours required to complete this project totaled 9,000 hours. Our scope of work included all of the design, implementation, validation documentation, validation execution and post-FDA audit resolution.

Drug Manufacturing–DCS, Fieldbus, DeviceNet

RoviSys was the lead integrator in this large-scale drug manufacturing project. The production facilities consist of three new manufacturing trains. RoviSys engineered the control system for the crystallization, centrifugation, drying and bulk packaging of the intermediate. RoviSys also configured the control system for new reactors and auxiliary equipment. The I/O count for this facility totaled approximately 3,000 I/O points and included complex batch configuration. Our scope of work included all of the design, implementation, validation documentation, validation execution and post-FDA audit resolution.

Protein Manufacturing–DCS, Fieldbus, DeviceNet, PLC Interface

RoviSys was recently chosen as the lead integrator for a grass root Large Scale Manufacturing Facility (LSM). This protein manufacturing facility will be implemented in two phases. Phase I includes the user requirements specification, functional requirements and programming standards development. Phase II will include detail design, construction, implementation and validation. The LSM facility is to be developed as a batch-aware facility consistent with the S88 standard for implementation. The LSM MEC encompasses batch reporting, data historian, process area equipment, process skid equipment, clean utility equipment and building utilities.

Vaccine Development and Manufacturing-Complex Batch DCS, PLCs, OPC

RoviSys is currently the lead integrator for a large full scale development vaccine facility. This complex batch project includes an I/O count of nearly 7,000 points managed by a distributed control system. The RoviSys scope of work included front-end process descriptions, functional specifications, design specifications, DCS configuration, test protocol generation, verification protocol generation and commissioning activities. RoviSys is also responsible for interfacing with multiple PLC skids via OPC and serial connections.

RoviSys Skid Vendor Experience

With the tremendous pressure to get product to market, RoviSys has noticed an increased use of Skid Vendor packages to streamline the process. This section overviews of how RoviSys works with these vendors as the lead integrator to ensure project execution is efficient and the final control system is fully integrated.

RoviSys has worked with Original Equipment Manufacturers (OEM’s) of skidded equipment and the customer to define, implement and startup this equipment. In these projects, the OEM’s equipment needed modifications for which they lacked the resources or knowledge to implement. RoviSys worked with the OEM and customer to define system requirements, get approval from the OEM, and to ensure the OEM’s warranties were intact. Some of these systems were:

Semi-Bulk Packaging Machines
Chromatography Skids
Chiller Systems
Filtration Skids
CIP / SIP Skids
Lyophilization Skids
Centrifuge Systems

At the request of our customers, RoviSys has taken the role of project manager and lead designer for the OEM where the OEM was contracted to make the required configuration changes.

In one scenario, RoviSys defined the scope changes in a System Functional Specification (SFS) which would be reviewed with the OEM. RoviSys then scheduled the required tasks to complete these modifications and schedule reviews with the OEM during the configuration effort to ensure accuracy. We also performed an official FAT before shipment.

In another scenario, RoviSys worked hand-in-hand with an OEM to incorporate the required changes needed by the customer. This project had multiple batch retort furnaces that needed to be customized. RoviSys was responsible for the overall control scheme while the OEM was responsible for the configuration of each individual furnace. To achieve this task, RoviSys treated the OEM as an extension of our engineering team.

Specifically, we instructed the OEM to treat their portion of the configuration as if they had only one furnace and configure that one furnace per the RoviSys System Functional Specification (SFS). RoviSys reviewed the configuration with the OEM. When it was completed we made the necessary configuration changes to allow unit allocation of the multiple furnaces and also incorporated aliases to allow the same code for one furnace to be utilized on all of the furnaces. This whole process was completed with the ultimate customer viewing the OEM and RoviSys as one company, thus avoiding any conflicts—and resulting in a successful project.

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Pharmaceutical Home Design Documentation Commissioning Validation Integration Training - Validation Batch controls Electronic Batch Records MES Experience Project Experience Latest Trade Show Validation Automation Brochure (Adobe Acrobat PDF 300KB) John Turk, Director Pharmaceuticals 330.995.8218 The RoviSys Company 1455 Danner Drive Aurora OH 44202 330.562.8600 Southeast Office 2521 Schieffelin Rd. Apex NC 27502 919.387.1200	Project Experience RoviSys has been working with many of the world’s leading pharmaceutical and biotechnology Companies for more than a decade. These clients have asked us to perform every aspect of automation project. We have successfully implemented small and large projects with the same focus on results that has fueled our growth and encouraged long-term relationships with our customers. Some of our larger pharmaceutical projects have exceeded $3 million dollars in engineering scope with more than 30,000 value-added engineering hours. We have been responsible for every engineering task required to define, implement, validate and startup a validated control system, including: Creation of User Requirement Specifications Creation of the validation documents required for the System Development Life Cycle (SDLC) Activities. System engineering to implement the control philosophies for basic control with interlocks and complex batch control. Training in the procedures required for validation testing and sign-offs. Validation execution and signing of validation documents. Training on audit interfacing with the FDA Post-FDA audit punch list resolution Recent project work is listed below. For more information on RoviSys pharmaceutical and biotechnology project case histories, contact John Turk or John Hall at 440-562-8600.: Batch Retorts–DCS, PLC skid system, OPC, RFID Tracking RoviSys was the lead integrator for a Batch Retort Furnace project. This project involves seven batch retorts using a distributed control platform. Product is shuttled into these furnaces via a PLC skid system that interfaces with the DCS via an OPC connection. Barcode readers communicating via DeviceNet at 12 locations identify where the shuttle baskets are and confirm delivery of the proper basket to the proper destination. The I/O count for this system is approximately 1,000 points. Our scope of work includes all of the design, implementation, validation documentation, validation execution and post-FDA audit resolution. We are also responsible for the supervision of the OEM’s skid-mounted equipment and interfacing with the material management system via a redundant OPC connection. Drug Manufacturing–DCS, Fieldbus, DeviceNet RoviSys was the lead integrator in the system engineering for this large-scale drug manufacturing project. Our complex batch DCS configuration controlled the process in the regeneration, harvest and isolation areas. A significant portion of the code dealt with the arbitration of a shared CIP/SIP skid package. The I/O counts totaled approximately 2,500 points and the engineering hours required to complete this project totaled 9,000 hours. Our scope of work included all of the design, implementation, validation documentation, validation execution and post-FDA audit resolution. Drug Manufacturing–DCS, Fieldbus, DeviceNet RoviSys was the lead integrator in this large-scale drug manufacturing project. The production facilities consist of three new manufacturing trains. RoviSys engineered the control system for the crystallization, centrifugation, drying and bulk packaging of the intermediate. RoviSys also configured the control system for new reactors and auxiliary equipment. The I/O count for this facility totaled approximately 3,000 I/O points and included complex batch configuration. Our scope of work included all of the design, implementation, validation documentation, validation execution and post-FDA audit resolution. Protein Manufacturing–DCS, Fieldbus, DeviceNet, PLC Interface RoviSys was recently chosen as the lead integrator for a grass root Large Scale Manufacturing Facility (LSM). This protein manufacturing facility will be implemented in two phases. Phase I includes the user requirements specification, functional requirements and programming standards development. Phase II will include detail design, construction, implementation and validation. The LSM facility is to be developed as a batch-aware facility consistent with the S88 standard for implementation. The LSM MEC encompasses batch reporting, data historian, process area equipment, process skid equipment, clean utility equipment and building utilities. Vaccine Development and Manufacturing-Complex Batch DCS, PLCs, OPC RoviSys is currently the lead integrator for a large full scale development vaccine facility. This complex batch project includes an I/O count of nearly 7,000 points managed by a distributed control system. The RoviSys scope of work included front-end process descriptions, functional specifications, design specifications, DCS configuration, test protocol generation, verification protocol generation and commissioning activities. RoviSys is also responsible for interfacing with multiple PLC skids via OPC and serial connections. RoviSys Skid Vendor Experience With the tremendous pressure to get product to market, RoviSys has noticed an increased use of Skid Vendor packages to streamline the process. This section overviews of how RoviSys works with these vendors as the lead integrator to ensure project execution is efficient and the final control system is fully integrated. RoviSys has worked with Original Equipment Manufacturers (OEM’s) of skidded equipment and the customer to define, implement and startup this equipment. In these projects, the OEM’s equipment needed modifications for which they lacked the resources or knowledge to implement. RoviSys worked with the OEM and customer to define system requirements, get approval from the OEM, and to ensure the OEM’s warranties were intact. Some of these systems were: Semi-Bulk Packaging Machines Chromatography Skids Chiller Systems Filtration Skids CIP / SIP Skids Lyophilization Skids Centrifuge Systems At the request of our customers, RoviSys has taken the role of project manager and lead designer for the OEM where the OEM was contracted to make the required configuration changes. In one scenario, RoviSys defined the scope changes in a System Functional Specification (SFS) which would be reviewed with the OEM. RoviSys then scheduled the required tasks to complete these modifications and schedule reviews with the OEM during the configuration effort to ensure accuracy. We also performed an official FAT before shipment. In another scenario, RoviSys worked hand-in-hand with an OEM to incorporate the required changes needed by the customer. This project had multiple batch retort furnaces that needed to be customized. RoviSys was responsible for the overall control scheme while the OEM was responsible for the configuration of each individual furnace. To achieve this task, RoviSys treated the OEM as an extension of our engineering team. Specifically, we instructed the OEM to treat their portion of the configuration as if they had only one furnace and configure that one furnace per the RoviSys System Functional Specification (SFS). RoviSys reviewed the configuration with the OEM. When it was completed we made the necessary configuration changes to allow unit allocation of the multiple furnaces and also incorporated aliases to allow the same code for one furnace to be utilized on all of the furnaces. This whole process was completed with the ultimate customer viewing the OEM and RoviSys as one company, thus avoiding any conflicts—and resulting in a successful project.
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