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

1. Pharmaceutical Microbiology:
Getting Lean
with Automation
with Kevin Walsh

2. We’ve come a long way…

3. • Being Lean in Micro QC
• Identification of Waste
• Lean through Automation

4. Being Lean in Micro QC

5. Principles of Lean
• Identify Value
• Customer focus
• Map the Value
Stream
• Activities, material,
people, information
• Identify and eliminate all
types of waste
• Create Flow
• Keep value steps tight
• Establish Pull
• Respond to demand
• Strive for
Perfection

6. Challenges of Being Lean
• Rigid documentation policies
• Validated processes
• External regulatory requirement
compliance
• Management support

7. Identification of Waste

8. Toyota’s Three Types of Waste
• MUDA
• Also known as the “seven forms of waste”
• MURI
• Waste due to overburdening or stressing the people,
equipment or system
• MURA
• Waste due to variation

9. MUDA – Seven Forms of Waste
Waiting
Transportation
Over-production
Defects/Errors
Inventory
Motion
Excessive Processing

10. Value Stream Mapping

11. Value Stream Mapping

12. Lean Through Automation

13. Reduce Motion
• Reduction/Elimination of
repetitive steps
• “Set it and Forget it”

14. 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
Product
Release OR ID
Day 7
Pull Samples
Perform Counts
Record Counts
Review & Key Into LIMS
Dispose Samples

15. 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
System
Day 3
Pull Samples
Perform Counts
Record Counts
Return Samples
Shift Samples
Product
Release OR ID
Day 7
Pull Samples
Perform Counts
Record Counts
Review & Key Into LIMS
Dispose Samples

16. Reduce Waiting/Time
• Automated rapid micro
technologies provide results
much faster than traditional
methods
• LIMS integration provides
immediate data submission
• Real-time results allow for
immediate action

17. Traditional Testing
Documentation
Tally Count
Production
Sample
Personnel
Transport to QC
Enter/Exit
Clean Area
Incubation
Reception
Documentation
Enumeration
Sample Surfaces
QC
Sample Air
Transport to Production
Data Entry
Documentation
Prepare Work Lists
and Consumables
To LIMS
Approvals
Approvals
To EM

18. Automated Testing
Documentation
Sample
Personnel
• Incubation
• Enumeration
• Documentation
Tally Count
Production
Enter/Exit
Clean Area
Samples to System
Automated
Auto Data
To LIMS
and EM
Work Lists
Sample Surfaces
Automated
Sample Air
Consumables
from Production
Approvals

19. Reduce Transportation
• Automated QC Systems placed
in the production environment
eliminate moving samples
across the facility
• LIMS integration (automated
documentation) reduces the
transportation of result files

20. Reduce Transportation
Automated 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

21. Reduce Defects/Errors
•
Incubation Errors
-
Serial incubation or interim counts
-
Samples placed in wrong
incubator or thrown away after
only one cycle
•
Enumeration Errors
•
Data Transcription Errors
-
Paperless labs

22. 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

23. Summary of Lean Benefits
• Automation for QC Micro (cont’d)
- Reduce/Eliminate transporting samples and data
-
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

24. 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

25. 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

26. Go Get Lean!
• Automate your QC Micro Testing
- Rapid Technology
- Incubation
- Enumeration/Analysis
- Integrated Data Management

27. Questions?

28. Contact Us Today
Are you ready to automate your QC Micro testing?
www.rapidmicrobio.com
Phone: 781-271-1444
For General Information: info@rapidmicrobio.com
For Sales and Product Inquiries: sales@rapidmicrobio.com