Fermenter Data Historian

A robust and auditable reporting solution offering a real-time view of pharmaceutical batch processes and meeting rigorous compliance standards.

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Pfizer required a local historian to capture data from the process control system; and a suite of reports describing operational process data.

All of which would stand up to the rigorous testing and auditing of the pharmaceutical industry.

GTS were selected as local PI System experts and the only Australian integrators with specialised RtReports skills.

Technical Situation

The Thebarton Pfizer plant had a Siemens PCS7 for operational data together with a separate application for recipe configuration data; but no historian or reporting tool.

One challenge was that the PCS7 system was quite old and didn’t currently have the OpenPCS plug-in.

Solution

Pfizer was a global OSIsoft Enterprise Agreement (EA) customer so the preferred position was to implement a PI System on premise.

The scope of the project was divided therefore between OSIsoft (implementing the core system components and interfaces); and GTS (building the solution on the PI System infrastructure provided.

Siemens provided the OpenPCS software, and off the shelf PI OPC DA and OPC A&E interfaces were implemented to capture both real-time; and alarm & event data.

An interface to the recipe source was also implemented so that the recipe settings were available to PI via the PCS7 interface.

Using an extract of Pfizer data, GTS developed an Asset Framework structure, and Event Frames to suit the report requirements (i.e. capturing batch processes based on ‘state’ data provided by the PCS7).

PI RtReports

OSIsoft’s RtReports provides the security and versioning of report configuration and operational data required by the pharmaceutical industry.

RtReports comply with regulatory requirements to facilitate use of electronic records, most notably U.S. 21 CFR Part 11 – Electronic Records and Electronic Signatures.

RtReports can be used to specify the format, data, and management of reports based on the plant configuration, specifications, and production data store in the PI System. 

RtReports can be used to create batch-based reports or time-based reports which are fully versioned and auditable and can include operational data, external data sources (e.g. relational databases and web services) and sophisticated calculations based on available data.

As Australia’s only experienced RtReports specialists GTS was designed and developed 10 RtReports including:

  • Fermenter Pressure Hold Leak Test
  • Nutrient Vessel Pressure Hold Leak Test
  • Steam in Place
  • Clean in Place
  • Growth
  • Recipe edit log
  • Recipe parameters
  • User logons

PI Vision

PI Vision provides a web-based user-friendly dashboarding tool ideal for users to gather and arrange data in ways meaningful to themselves; and share those views with others.

Vision was implemented as an ad hoc visualisation tool allowing users to navigate the fermenter data structure and build displays to assist with tactical and strategic decision making.

Project Outcomes & Benefits

The resulting solution provided a robust platform:

  • Meeting regulatory & compliance standards
  • Proving real-time access to process data
  • Delivering a robust and auditable real time batch and scheduled reports solution
  • And capturing alarm and event data for deeper analysis
Andrew Todd
Andrew Todd

Chief Executive Officer

OSIsoft’s RtReports are designed for pharmaceutical batch reporting and one of those rare skills GTS has developed through our specialisation in this field.

Andrew Todd

Chief Executive Officer at GTS Group

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