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
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
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
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
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
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