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Few pharmaceutical manufacturers can afford to compensate for inefficiencies with large inventories. Fortunately, leaner methods are available! During this presentation, you will learn how to: - Be lean in Micro QC - Identify areas of waste - Get lean through automation
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Getting Lean
with Automation
Pharmaceutical Microbiology:
with Automationwith Kevin Walsh
We’ve come a long way…
• Being Lean in Micro QC
• Identification of Waste• Identification of Waste
• Lean through Automation
Being Lean in Micro QCBeing Lean in Micro QC
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
Challenges of Being Lean
• Rigid documentation policies
• Validated processes• Validated processes
• External regulatory requirement
compliance
• Management support
Identification of WasteIdentification of Waste
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
MUDA – Seven Forms of Waste
InventoryTransportation
Waiting
Defects/Errors Excessive Processing
MotionOver-production
Value Stream Mapping
Value Stream Mapping
Lean Through AutomationLean Through Automation
Reduce Motion• Reduction/Elimination of
repetitive steps
• “Set it and Forget it”• “Set it and Forget it”
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
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
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
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
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
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
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
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
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
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
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
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
Go Get Lean!• Automate your QC Micro Testing
- Rapid Technology
- Incubation
- Enumeration/Analysis
- Integrated Data Management
Questions?Questions?
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]
