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As part of the expansion of its local manufacturing capacity, a major pharmaceutical company constructed a new facility in North Ryde, NSW. This facility contains suites used for the manufacture of existing and new pharmaceutical products for domestic and export customers.

The suites concerning this project are used to manufacture sterile solutions suitable for human injection.

The scope of the project was the design, testing and documentation of the SCADA, PLC, Report and Database related software for 3 of these suites. This included the development of custom software for simulation testing. The project covered the full life cycle from Tender through to Handover to Validation.

The project followed a GAMP standard V model and consisted of the following phases:

URS – User requirements specification, development of a User Requirements Specification and a Scope of work document to cover additional contractual details.

TENDER – This involved producing a report on the abilities of the various short listed subcontractors and a decision matrix to ensure a fair assessment based on prioritized criteria. This included a Project Plan, Resources Base, Service abilities, Pricing, Quality system, Experience.

QUALITY PLAN – It was necessary to produce a specific quality plan to impose the required controls on the development and documentation phases for the project.

FDS – Production of a Functional Design Specification this included an appendix of Sequence logic separately controlled as an SDS Software Design Specification.

SMDS – Software Module Design Specification, this detailed in a top down manner the structure, precise logic and addressing of the functions used to implement the requirements.

STS – Software Test Specification, this contained the plan
for the testing including the systems to be utilized and the methodology.
Including testing of the testing tools.

FAT Test Document (Factory Acceptance Testing). This document was accompanied by an FAT test results file which together detailed the exact tests performed, the acceptance criteria and evidence of the tests being completed successfully. This testing utilized 6 PC’s as follows:

1) PC with custom written VB Spreadsheet to record I/O activity.
2) PC to act as SCADA station
3) PC to act as redundant SCADA I/O server
4) PC to act as SQL server (Database for reports)
5) PC to view and capture PLC logic performance.
6) PC to run custom written simulation software (separate lifecycle)

SAT Test Documents (Site Acceptance Testing) This phase of testing aligned with the SDS component of the FDS and the SMDS, SAT Testing. This testing involved the testing of the software onsite. This testing aligns with the FDS. Upon completion of the SAT testing the project was handed over to Validation.

LSP- Learner Session Plan. This extensive document was a training tool produced for the end user’s engineers. The document in electronic form contained links to all related documents and as such became expanded to act as an electrical and mechanical knowledge base.

REVIEW DOCUMENT– This detailed the reviews performed on each of the phases and associated documents, It also served as a traceability matrix to relate sections of different documents to each other.

Project statistics

The project resulted in some valuable software tools and templates being available to other projects. These included a package to record and playback in realtime PC screens giving unprecedented evidence of testing, as well as an Excel spreadsheet that records PLC I/O activity in this case it was used as a valve matrix to record valve operations with sequence steps.

This project was hailed as an outstanding success as the software cost less than any previous suites, was completed in far less time and broke all previous records for SAT / commissioning and Validation performance.

The project gave Fast Automation exposure, experience and the opportunity to demonstrate it’s ability to policing subcontractors in pharmaceutical standards in the following areas:

• Change Controls
• Document Control
• SOP’s
• Quality Planning
• Project Management
• Following a V- Model
• Design Reviews
• Acceptance Testing
• Validation of Computerised Systems

Standards

• Australian Code of Good Manufacturing Practice for Therapeutic
  Goods
• EU Guide to GMP for Medicinal Products, Annex 1 – Manufacture
  of Sterile Medicinal Products, January 1999
• GAMP3- Supplier Guide for Validation of Automated Systems in
  Pharmaceutical Manufacture – 1998

A major Gas company required the conversion and updating of its gas cylinder filling systems globally. A contract to undertake this task was given to a major systems integration company “Dickinson Autocon” Pty Ltd Based in Sydney. Fast Automation was subcontracted to assist in this project.

Scope of the main project:

The main project entailed the design, development and implementation of a secure and maintainable control system, to automate the mixing and filling of gas to an unlimited number of recipes. This encompassed the electrical & software design through to commissioning. The system had to be compatible with an existing complex algorithm for filling volatile gasses. The system also had to be flexible and generically applied to widely differing filling plants without code changes.

Fast Automation’s part:

The customer supplied a URS for each plant- from this Fast Automation undertook the following:

• Process Design Specification – Containing drawings and in a very controlled syntax text for describing the Stepping logic & procedures required of the filling system
• Generation of an FDS (Functional Design Specification) – this document was extensive and contained very detailed information on every step of the process, all software functions, Graphical screen dumps, report examples, recipe structure, parameter listings etc as well as the system architecture and hardware to be used.
• Generation of SCADA Application – including, plant mimics, live device profiles, recipe handling, reports, alarms annunciation and logging, security policy, command prompts for instructing operator actions, custom auto barcode label printing software etc.
  Generation of Simulation application – to allow full simulation of the complete system off site.
• PLC Programming – Heavy monitoring and assistance in the PLC programming to the FDS & PDS including complete coding of various code modules. Setting up and testing of OMRON’s CLK DataLink network to allow PLC’s to share memory areas.
• Production of STS Software Test Specification – this contained the plan for the testing including the systems to be utilized and the methodology.
• Automation Support Document – this extensive document described how to perform future tasks such as replacing the PLC program, troubleshooting faults, rebuilding SCADA PC’s and how to configure the software for each plant.
• Commissioning of 2 early plants.
• Generation of SCR – Site Commissioning Reports to control & document the successful commissioning of each plant in a safe manner.

Project statistics:

The project presented a number of challenges: The Que system was very complex and required searching ahead of recipes to allow filling of the same gas to different locations to be done in parallel but only under strict conditions. SCADA requirements were unique in that the whole application changed graphically and functionally between sites but used the same code with different configuration options set – this was a very valuable synergy suggested and introduced to the project by Fast Automation. The reporting was very extensive with different levels of reports required per gas filling module, per operator, per Fill, per shift etc. The Alarm’s handling was extensive and the history sorted per logical area. Every action was monitored all control is closed loop – with a back up loop. The Recipe handling allowed for unlimited ordering of procedures and setting of procedure step parameter sub steps, but with different rules for each plant. Then the actual filling of gases that behave differently both at different pressures and different temperatures was always the main challenge of the system, the parameters of control are then all different again for each gas type! and each gas combination. For example adding CO2 cools a mixture most other gases increase the temperature so the control loops must cope with this. The commissioning window of the whole system – electrics and software was only 4 days Friday to Monday with filling to resume on Tuesday.

Summary:

This project was a unanimous success and resulted in all objectives being met. The systems & knowledge developed are valuable to all projects that require very flexible recipe handing, short downtime / changeover and full offsite simulation.

Fast Automation was given the opportunity to audit how a major international airports baggage handling system would cope with power outages. The Audit is subject to confidentiality agreements but resulted in the following main activities:-

• Custom designed UPS solutions for over 110 PLC based systems.
• Supervisory dedicated SCADA with power controlling switches
• Replacement of PLC batteries
• Software revision control strategy and deployment
• ATS (automatic transfer switches) deployment
• Large Scale outage testing with automated result sets
• Complete database of all critical Technology part numbers
• Power division strategy (essential and non-essential division)
• Presentation and high level reporting of major activities, and weakness categories and weightings for forward operations.
• Scenario work-shopping and contingency planning.
• Overall 3D graphical depictions of operation through outages.
• Operating Procedures, and exercise execution and management.
• Architecture Topology drawings and decision matrix evaluations.