Industry: Life Science
Application: Product Manufacturing
A leading manufacturer of healthcare products built a new production area at an existing facility to respond to market needs.
The manufacturing area consisted of the following:
- 6 Bulk Tanks /w truck unload area (22 phases total)
- 8 Hold Tanks (10 phases each)
- 2 Preparation Make Tanks (14 phases each)
- 4 Mix Tanks (28 phases each)
- Premix Room (24 phases)
- USP Water System (3 loops, 34 drops)
- 4 CIP Skids (19 phases each)
- 6 Auxiliary CIP Tanks (32 phases total)
- 2 Washers (11 phases each)
- 3 Packaging Fillers
The requirements for the control system in the new manufacturing area included:
- A Flexible Manufacturing System compliant with ISA S88 standards.
- Process visualization, electronic work instructions and alarm management.
- Generation of Electronic Batch Records (EBR).
- Compliance to 21 CFR Part 11 for electronic records and electronic signatures.
- Interface to multiple plant systems including the plant MES.
- Generation of IOQ documents and validation support.
The challenge was to design, implement and install a large-scale sophisticated system in a regulated industry under a tight schedule and budget without compromising high corporate standards. The design and development process closely followed GAMP 5 guidelines, relied heavily on the ISA-S88 model, and used ControlBuilder® a software development toolset. The ISA S88 model applied to all aspects of the project including gathering of information for the specifications, system design, documentation, testing, commissioning and validation. Key to the success of the project was ControlBuilder®, a data-centric software toolset that facilitated the collection of information gathered during each stage of design and development.
- 15 Allen Bradley ControlLogix L73 PLC’s
- 4671 I/O
- 479 Phases
- 10 Servers
- 25 Wonderware InTouch SCADA Clients
- 33 Wonderware InBatch Units (redundant InBatch Servers)
- Wonderware ArchestrA Object Count
- 3675 objects
- Wonderware EMS Monitoring 270 points
- Wonderware Historian – 1900 tags configured
- SQL Reporting
- Batch List
- Batch Report
- Alarm Summary Report
- Audit Trail Report
- Cleaning Report
- MES interface to SAP for goods issue/receipt
- Entire system is duplicated in a Virtual Factory environment for training with simulation.