BMS in Regulated Industries: the end-users perspective

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2 BMS in Regulated Industries: the end-users perspective 2013

3 Presenter Kevin Dignam, Project Engineer in Teva, Haarlem 30 years experience working in pharma industry, EI&A background Formerly worked as EI&A Manager with an engineering consultancy, executing multiple projects for pharmaceutical manufacturers Former Society Vice-President, Executive Board and Executive Committee member of ISA, the International Society of Automation

4 Who are Teva? One of the top-10 pharmaceutical companies worldwide Number 1 in the United States and Europe The largest supplier of generic medicines in the world. Specialized in the development, production and marketing of proprietary, generic and OTC medicines, active pharmaceutical ingredients and novel therapeutic entities Production of 73 billion capsules and tablets per year Activities in over 60 countries Products are sold in over 120 markets Global product portfolio of more than 1000 molecules Approximately employees worldwide Turnover: more than US$ 20,3 billion in 2012

5 Secondary headline Text bold Text

6 Teva Haarlem: large campus comprising: Sterile fill finish facility Inhalation capsule Production facility Packaging 800+ employees 2 production buildings High-bay warehouse, automated stacker cranes, AGV s QC and R&D laboratories Office buildings Teva Nederland head office

7 Existing GBS installation Approximately 5,000 I/O covering all facilities Validated system, used for GMP monitoring of production facilities Used for control of HVAC and black utilities throughout the campus

8 Status of existing system (1) Legacy system comprising several generations of controllers from the same manufacturer System obsolete and no longer supported by manufacturer Spare parts no longer readily available Difficult to revalidate and to validate changes

9 Status of existing system (2) Entire system validated (controlling and monitoring): costly and unnecessary Occasional short-term power dips on the electrical power network (external) causing systems to drop out Frequent alarms due to older installation standards used on original installation

10 The solution Upgrade of GBS to state-of-the-art system (BMS) Removal of the validation burden from the BMS Installation of separate, validated Facility Monitoring System for GMP data registration During GBS upgrade, replacement of all field devices many of which were obsolete Also during upgrade, all field cables replaced by cables with up to date specifications

11 The approach Worked with specialist consultant to determine best technical and commercial solutions for BMS replacement Carried out comparative review and analysis of main BMS solutions in marketplace Executed detailed and exhaustive surveys of existing installations Determined criticality of existing systems in order to decide order of system upgrade

12 The challenges Documentation for existing GBS system Minimal outages available for changeover Limited to changeover of HVAC systems during bi-annual maintenance stops Preparatory works to be done while working above operational cleanrooms Dealing with the result of short-term power dips Cashflow & budgetary approval

13 Solutions (1) Selected a PLC/SCADA solution over a proprietary BMS based on technical and commercial aspects Installed a high-speed, site-wide BMS (SCADA) network to ensure futureproofing Replaced VFD s with new units with ride-through facility to cover voltage dips In parallel with BMS project, installed site-wide UPS for all controllers to protect against voltage dips

14 Solutions (2) In advance of BMS project, installed and qualified a validated FMS for GMP data registration Implement the changeover on a phased basis to minimise plant downtime, starting with the most critical Standardised design (software, hardware, field equipment) as far as possible so that all HVAC systems used a common control architecture Standardisation assisted with start-up and commissioning effort

15 Current status and project progress 60% of fill-finish facility HVAC systems (most critical units) converted Other systems are replaced as dictated by project work and/or building upgrades Substantial reduction in the amount of nuisance alarms being generated Next steps: funding secured to complete fill-finish HVAC systems Implement BMS on upcoming fill-finish expansion and on new OSD plant currently under construction

16 Learning points Don t be the guinea pig, don t allow unproven technology onto your plant Keep the entire project responsibility with one company: hardware, software (BMS, SCADA and any other interfaces), cabling, panels, field devices Choose your installation contractor carefully Consider using a dedicated BMS server operated and maintained by the BMS technical owners Secure and maintain the early involvement and contribution of all stakeholders in the project (production, senior management, utilities, engineering, vendor, ICT dept, EHS)

17 If you always do what you ve always done, you ll always get what you ve always got Anthony Robbins

18 Question and answers Thank you for listening. Any questions?

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