smart plant workflow for business process … plant workflow for business process automation ......
TRANSCRIPT
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Mary Grow, VP ET & Business Processes, JHP Pharmaceuticals Ty Chasey MES Consultant, Gray Matter Systems
17 – 19 August 2011
Put-In-Bay, Ohio
SMART PLANT
Workflow for Business Process Automation in a Regulated Environment
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• Industry & Markets
• Commercial pharmaceutical: no innovator R&D or clinical trials • Key products: Injectables in vials and ampoules • Key production technology: lyophilization • branded products: primarily USA with some export to resellers • contract manufacture: primarily USA; certified to export to 86 countries
JHP Company Overview
• Competitors • Other generic injectable manufacturers/marketers (Hospira) • Other injectable contract manufacturers (HollisterStier, DSM, BVL) • “Big pharma” (Pfizer, Sanofi, etc)
• Business Strategy Overview • Focus strengths on generic developments • improve market share via cost containment & product differentiation • maintain current regulatory position but continue to improve • preserve EBITDA • self-finance where possible • retain control of customer-touch activities
• Corporate Structure • Partnership – Peter Jenkins & Stuart Hinchen • Majority investor: Morgan Stanley • Location: Rochester, MI & Parsippany, NJ • Employees: approx 350
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The injectible drug production process
hybrid
“data intensive”
costly
regulated
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A current performance indicator......
Pharmaceutical
Semiconductor
Sigma (σ) ppm Defect Yield 2 308,537 69.15% 3 66,807 93.32% 4 6,210 99.38% 5 233 99.98% 6 3.4 99.99966%
Process Automation – Why the focus now in the pharmaceutical industry
Conventional Pharmaceutical
Manufacturing….
• production: batch processing • quality assurance: laboratory testing of collected samples • process change management: via regulatory submissions “ Significant opportunities exist for improving pharmaceutical development, manufacturing, and quality assurance through innovation in product and process development, process analysis, and process control.”
….vs the Innovation
challenge….
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Compliance regulators pushing records digitization, process understanding, predictive analytics Customer Service customers demanding newer technologies including serialization and track & trace Corporate growth profitably now means significant productivity gains in operations Cash flow / Cost containment “cost per vial” metric even more important as company moves to generics
Process Automation Why the focus now at JHP
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…but with a set of common goals…
Product Quality
Efficiency
Innovation Availability
Stability
Cost
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Process Automation – How we got started....
Operations: operational effectiveness understanding business processes paper reduction Facilities focus: equipment upgrades / replacement process understanding quality control ET focus technical operations support new technology deployment
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Introduction to the Solution What we’ve done to date…………
Project 1: Workflow to make plant apps more inclusive and effective What we did: Combined iFix, Historian, Workflow, and Plant Applications to collect contextualized Batch data.
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Sterile Fill Mission Control
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Sterile Fill Mission Control
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Sterile Fill Mission Control
• Both Plant Applications and Workflow seamlessly integrate into the iFix environment.
• Plant Applications adds context to downtime events.
• Workflows - paperless batch reconciliation.
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Sterile Fill Mission Control
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Plant Applications Web Reports • Entire operation has access
to OEE, Downtime, Environmental Trends, and Production Reports.
• Some report highlights include: – Production vs. environmental
data – Start-up issues
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Production vs Environment
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Production Run Start-Up issues
2.5 hours late
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Introduction to the Solution What we’ve done to date…………
Project 2. Workflow to support our paper reduction efforts….. …..and lay the foundation for electronic batch record
What we did: replaced paper forms with screens for data input for batch reconciliation
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Sterile Fill Mission Control and Workflow Integration
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Workflow – Start Batch
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Workflow – End Batch
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Process Automation Example 3: electronic batch record
What we’re doing now: Finalizing the spec for an electronic batch record
– Environmental Data – PAT / Process Improvement – Following the FDA approved validation
process and filling out required forms. – Data is stored in S95 Production Model
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The Challenge for JHP… Any change impacting product must be approved by outside agencies.
We have to change the engine without pitting the car.
We are implementing in a somewhat “hostile” physical environment.
We have to convince our employees that this is not going to replace them.