Download - Getting Lean in the Micro QC with Automation
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Getting Lean
with Automation
Pharmaceutical Microbiology:
with Automationwith Kevin Walsh
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We’ve come a long way…
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• Being Lean in Micro QC
• Identification of Waste• Identification of Waste
• Lean through Automation
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Being Lean in Micro QCBeing Lean in Micro QC
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Principles of Lean• Identify Value
• Customer focus
• Map the Value
• Create Flow• Keep value steps tight
• Establish Pull• Map the Value
Stream • Activities, material,
people, information
• Identify and eliminate all
types of waste
• Establish Pull• Respond to demand
• Strive for
Perfection
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Challenges of Being Lean
• Rigid documentation policies
• Validated processes• Validated processes
• External regulatory requirement
compliance
• Management support
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Identification of WasteIdentification of Waste
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Toyota’s Three Types of Waste• MUDA
• Also known as the “seven forms of waste”
• MURI• MURI
• Waste due to overburdening or stressing the people, equipment or system
• MURA
• Waste due to variation
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MUDA – Seven Forms of Waste
InventoryTransportation
Waiting
Defects/Errors Excessive Processing
MotionOver-production
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Value Stream Mapping
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Value Stream Mapping
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Lean Through AutomationLean Through Automation
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Reduce Motion• Reduction/Elimination of
repetitive steps
• “Set it and Forget it”• “Set it and Forget it”
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Typical Water or Bioburden Test(~8,000 – 12,000 Samples/Year)
Day 1
Pull QC Test Form Fill out Assay info Prepare Sample Load Incubator
Day 3
Pull Samples Perform Counts Record Counts Return Samples Shift Samples
Day 7
Pull Samples Perform Counts Record Counts Dispose SamplesReview & Key Into LIMS
Product
Release OR ID
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Automated Water or Bioburden Test(~8,000 – 12,000 Samples/Year)
Day 1
Pull QC Test Form Key Assay into
Automated System Prepare Sample Load to Automated
SystemAutomated System System
Day 3
Pull Samples Perform Counts Record Counts Return Samples Shift Samples
Day 7
Pull Samples Perform Counts Record Counts Dispose SamplesReview & Key Into LIMS
Product
Release OR ID
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Reduce Waiting/Time• Automated rapid micro
technologies provide results
much faster than traditional
methodsmethods
• LIMS integration provides
immediate data submission
• Real-time results allow for
immediate action
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Traditional Testing
Production
Documentation Tally Count
Sample Personnel
Enter/ExitClean Area Reception
Documentation
Incubation
Transport to QC
Sample AirSample Surfaces QC
Documentation
Approvals
Documentation
Enumeration
Prepare Work Lists and Consumables
To EM
To LIMS
ApprovalsTransport to Production
Data Entry
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Automated Testing
Auto Data
Automated
Work Lists
Samples to System
Automated • Incubation
• Enumeration
• Documentation
Production
Documentation Tally Count
Sample Personnel
Enter/ExitClean Area
Production
Documentation Tally Count
Sample Personnel
Enter/ExitClean Area
Consumables from Production
Auto Data
To LIMS
and EM
Work Lists
Approvals
Sample AirSample Surfaces Sample AirSample Surfaces
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Reduce Transportation• Automated QC Systems placed
in the production environment
eliminate moving samples
across the facilityacross the facility
• LIMS integration (automated
documentation) reduces the
transportation of result files
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Reduce TransportationAutomated Testing Can be Located at Production
Huge campus adds non-productive travel
time for QC
Microbiologists must suit up in sterile garments
to enter cleanrooms
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Reduce Defects/Errors• Incubation Errors
- Serial incubation or interim counts
- Samples placed in wrong incubator or thrown away after incubator or thrown away after only one cycle
• Enumeration Errors
• Data Transcription Errors
- Paperless labs
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Summary of Lean Benefits• Automation for QC Micro
- Reduce time to results
- Implement automated rapid detection system
- Results in less than ½ the time
- Real-time results
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Summary of Lean Benefits• Automation for QC Micro (cont’d)
- Reduce/Eliminate transporting samples and data
- Install an automated system in the production area- Install an automated system in the production area
- Eliminate the transfer EM or product samples from the production area to the QC testing lab
- Eliminate timing errors with sample pick up and transport
- Automate data transfer by connecting your test system to LIMS
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Summary of Lean Benefits• Automation for QC Micro (cont’d)
- Remove incubation/enumeration tasks
- Eliminate time required to retrieve plates from incubators and
count colonies
- Eliminate counting and transcription errors
- Automate sample ID tracking and ensure data integrity
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FTE Savings
• At 100 tests/day average estimate of 1 FTE savings
• Typical pharma sites can recognize 2-4 FTE savings
Faster Product Release
• PCP company able to ship directly to retailer – no inventory costs
• Pharma saves 3+ production days
Documentation Reduction
• Paperless capabilities eliminates manual entry – saves hours/week
• Globally available data facilitates faster decision making
Error Avoidance
• CMO’s reduce errors
• Savings of $100K+ per year
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Go Get Lean!• Automate your QC Micro Testing
- Rapid Technology
- Incubation
- Enumeration/Analysis
- Integrated Data Management
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Questions?Questions?
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Contact Us Today
Are you ready to automate your QC Micro testing?
www.rapidmicrobio.comwww.rapidmicrobio.com
Phone: 781-271-1444
For General Information: [email protected]
For Sales and Product Inquiries: [email protected]