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PLANT/FACILITIES ENGINEERING IN THE PHARMACEUTICAL INDUSTRY. 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 - PowerPoint PPT Presentation
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PLANT/FACILITIES ENGINEERING IN THE PHARMACEUTICAL
INDUSTRY
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
DESIGN OF FACILITIES
NEW PHARMACEUTICAL PROJECT
ENGINEERING / PROCUREMENT / CONSTRUCTION / COMMISSIONING /START-UP / (VALIDATION)
PRODUCTION UTILITIESOFFICE WAREHOUSE
INFRASTRUCTURES PHARMAFACILITY
EXTERNALINFRASTRUCTURES
LABORATORIESCOLDROOM
BIOTECHASEPTIC &
STERILE FILLING
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
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
PROJECT INDICATORS
Did you meet project scope? Did you meet project timeline? Did the project was within budget?
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.
PREVENTIVE MAINTENANCE REQUIREMENTS
Tasks and frequency determined by:- Manufacturer’s recommendation- Historical data
Department supervisor and maintenance coordinator verifies completion of PM tasks
PM records maintained by the engineering department
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
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
DOWNTIME ANALYSIS
Sample report:
Traditional Roles
ProductionOperator
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
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
DefineDefine
MeasureMeasure
AnalyzeAnalyze(Create)(Create)
(Implement)(Implement)
ControlControl
Deci
sion
Pro
ble
mD
eci
sion
Pro
ble
m
Imple
menta
tion
Pro
ble
mIm
ple
menta
tion
Pro
ble
m
Define ProblemProblem StatementPareto Charts
Form TeamCharter Scope Project
SIPOC Map
Align w/CustomerVOCAffinity Diagram
What Data?“Five Points of View”
How to MeasureOperational Def’sMeasurements System Analysis
Which Units?Representative SamplesContextual Data
Plot DataTime Plots & Control ChartsFrequency Plots (Histo & Pareto)
Estimate Sigma
Map ProcessActivity FlowchartDeployment Flowchart
Focused Prob. Statement(Problem Specification)
List Probable CausesIs vs. Is NotFishbone/Fault Tree (Why)
Test (Verify) CausesScatter DiagramStrat Freq. PlotsTables
Analyze MapCycle TimesWastes
Develop SolutionsBrainstormingIdea Box, etc.
Set CriteriaMulti Voting
Choose SolutionPriority MatrixPugh Matrix
PlanImplementation
Planning Tools
Address Human Side
Leadership Tools
Anticipate Failure Mode
Process FMEA
StandardizeJuran’s PyramidFlow Charting
Train
MonitorProcess Management PlanControl Charts
6/14/2004
DMAIC ProcessDMAIC Process
Anticipate Failure Mode
Design FMEA
ImproveImprove
MANAGEMENT STANDARDS
EHS Global Management Strategic Planning Self Assessment / Risk Assessment Business Integration Training and Awareness Communication and Information Performance Measures Assurance Review
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
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
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
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
Preliminary Data
Monthly Consumption (m3)
0
50000
100000
150000
200000
250000
300000
350000
400000
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Month
m3
2005 2006
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
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
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”
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
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
VALIDATION LIFE CYCLE
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
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