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Presentation on theme: "PLANT/FACILITIES ENGINEERING IN THE PHARMACEUTICAL INDUSTRY."— Presentation transcript:


2 FUNCTIONS OF THE PLANT ENGINEERING DEPT Design and construction of facilities and systems Maintenance of facilities and systems Operation of system Environmental, Health & safety Regulatory compliance Energy management Technology Validation Administration, supervision, organization, planning


4 PROJECT PHASES Conceptual –Long range plan development (1-5 years in advance) Planning –Project scope development for next year (6-12 months in advance) Request for capital expenditures (RCE) –Develop RCE documentation 2-4 months in advance Execution –Immediately pre & post funding Closeout –Upon completion

5 TYPES OF PROJECT New water for injection system Chilled water upgrade Clean rooms upgrade Installation of a second bag printer Optimize clave cycles Install thermal oxidizers Electrical bussway upgrade Upgrade hot stamp system Overhaul blow mold deflasher

6 PROJECT INDICATORS Did you meet project scope? Did you meet project timeline? Did the project was within budget?

7 PREVENTIVE MAINTENANCE New equipment or changes are added to PM program via VCR (validation change request) Master PM describes: –Equipment identification –Frequency –Tasks to be performed Master PM approved by Maintenance coordinator, Engineering manager, Production manager, and Quality manager.

8 PREVENTIVE MAINTENANCE REQUIREMENTS Tasks and frequency determined by: -Manufacturers recommendation -Historical data Department supervisor and maintenance coordinator verifies completion of PM tasks PM records maintained by the engineering department

9 SHUTDOWN Include routine activity and projects Require project management tools Involve all department and contractors Training is critical to avoid safety issues Require maintenance resource availability

10 SPARE PARTS Increased focus on better utilization of our stockroom dollars Plants are making progress in reducing the cost and number of spare parts in inventory Alternate suppliers are being identified to reduce the cost of parts In-house & local machine shops are being utilized where possible to fabricate parts for less than OEM cost

11 DOWNTIME ANALYSIS Sample report:

12 Traditional Roles Production Operator Maintenance Mechanic Requisition/Place Materials Operate Line Monitor Process Variables Adjust Running Parameters Check Product Quality Place Maintenance Work Order Adjust Machine Setup Diagnose Unexpected Downtime Perform Routine Maintenance Perform Preventive Maintenance Perform Shutdown Maintenance Record Activities in CMMS Lead Reliability Improvement Projects Line Operator Example AUTONOMOUS MAINTENANCE Autonomous Maintenance

13 SWAT TEAMS-PROCESS IMPROVEMENTS SWAT teams are used in some form at all sites Involves Six Sigma, Cost Reduction teams and Maintenance Productivity teams Team Targets Lines based on Labor Performance, Material Performance, and Standard Units Produced Line Improvement Projects are selected based on Cost vs. Return just like RCE projects Team evaluates mechanical performance, processes and procedures Team tracks effectiveness and strives to make permanent fixes

14 14 Define Measure Analyze (Create) (Implement) Control Decision Problem Decision Problem Implementation Problem Implementation Problem Define Problem Problem Statement Pareto Charts Form Team Charter Scope Project SIPOC Map Align w/Customer VOC Affinity Diagram What Data? Five Points of View How to Measure Operational Defs Measurements System Analysis Which Units? Representative Samples Contextual Data Plot Data Time Plots & Control Charts Frequency Plots (Histo & Pareto) Estimate Sigma Map Process Activity Flowchart Deployment Flowchart Focused Prob. Statement (Problem Specification) List Probable Causes Is vs. Is Not Fishbone/Fault Tree (Why) Test (Verify) Causes Scatter Diagram Strat Freq. Plots Tables Analyze Map Cycle Times Wastes Develop Solutions Brainstorming Idea Box, etc. Set Criteria Multi Voting Choose Solution Priority Matrix Pugh Matrix Plan Implementation Planning Tools Address Human Side Leadership Tools Anticipate Failure Mode Process FMEA Standardize Jurans Pyramid Flow Charting Train Monitor Process Management Plan Control Charts 6/14/2004 DMAIC Process Anticipate Failure Mode Design FMEA Improve

15 MANAGEMENT STANDARDS EHS Global Management Strategic Planning Self Assessment / Risk Assessment Business Integration Training and Awareness Communication and Information Performance Measures Assurance Review

16 TECHNICAL STANDARDS Confined Spaces Entry Underground Storage Tanks Dangerous Goods / Hazardous Material Waste Facility Selection Machine Guarding Spill Prevention Hazardous Process Waste Management Ergonomics Water

17 TECHNICAL STANDARDS (continued) Emergency Preparedness Planning Air Emissions Significant EHS Incident Reporting Contractor EHS Management Reproductive Hazard Management Chemical Hazard Communication Capital Project Review Occupational Health Services

18 REGULATORY AUDITS The Audit criteria includes: –Federal & Local Environmental, Health and Safety Regulations, Good manufacturing practices Audit approach: –Facility tour –Inspections –Employee interviews –Documentation / records –Site programs and procedures –System design

19 ENERGY SAVING INITIATIVES Steam - natural gas –Steam trap maintenance –Pipes and valves insulation –More efficient equipment –Steam pressure adjustment –Sanitation frequency –Boiler economizer Electricity –High efficiency motors –Equipement operation schedules –Low consumption fluorescent lamps –Repair of compressed air leaks

20 Preliminary Data

21 PROCESS ENGINEERING Lyophilization Equipment Engineering Solution Preparation and Delivery System Engineering Pharmaceutical Water Systems Engineering CIP (clean in place) Systems Engineering SIP (steam in place) Systems Engineering Utility Systems Engineering Automation Engineering & Design Filtration Selection & Qualification Support

22 STERILIZATION ENGINEERING Terminal Sterilization of Final Product (Steam, Gamma, ETO) Sterilization of Commodities (Steam, Dry Heat, Gamma, ETO) Sterilization of Aseptic Filling Equipment (Steam, VHP, Dry Heat) Sterilization Cycle Development Sterilizer Equipment Design Sterilizer Tray/Rack Design New Product Submission Generation and Support

23 PAT Systems for analysis and control of manufacturing processes based on timely measurements of critical quality parameters and performance attributes of raw materials and in-process products, to assure end-product quality at the completion of the process

24 PAT OBJECTIVES Produce –The right quality –In the shortest time –At the lowest cost –Predictable fashion Pharmaceutical Manufacturing –Does not always meet all criteria –Efficiency is lower than comparable industries –Lots of room for improvement but improvement was almost discouraged

25 PAT-TECHNOLOGIES Simple sensors -pH, temperature, pressure, etc Spectroscopic -Near-IR, Imagers, Mid-IR, Raman, UV-Vis, etc Physical properties -Particle size and shape, thermal effusivity, acoustics, etc Classical analytical techniques -HPLC, GC, LOD, etc


27 VALIDATION IN THE FUTURE Shift to continuous validation concepts from up-front 3 batch concept (this comes with PAT) Increased usage of Commissioning activities and documentation to reduce IQ/OQ activities Focus validation efforts on product quality attributes Increased usage of documented Risk Assessments to streamline the validation testing

28 ADMINISTRATION Preparation of plant/facilities budget Management of capital projects and expenditures Support production goals Solicitation, preparation and administration of contracts Contracting and overseeing the activities of various contractors and consultants Maintenance of current as built drawings Hiring and coaching of the engineering employees Supervision of employees Maintain appropriate training and certification


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