special report: filling ops process improvement
DESCRIPTION
Special Report presentation: (5) Proven Principles to Prevent/Reduce Waste in Filling Manufacturing Processes.TRANSCRIPT
Preventing Waste in Liquid Filling Processes
How You Can Use (5) Proven Principles to Consistently Produce
Product In-Spec
June Yamada Consulting
“Transforming Operations to New Heights!”
Medical Device, Pharmaceuticals
In-Vitro Diagnostic Reagent Manufacturing
Liquid Drug Manufacturing
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Using Filling Equipment to fill containers/vials with liquid reagents/drugs.
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Out-of-spec (OOS) fill volumes.
$Millions in scrap/rework costs.
Risk to Patients
Goal: final fill volume consistently at target.
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Do you have Filling Processes costing you $Millions in Rework/Scrap Costs & Potentially causing Harm to patients?
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TEAM DEFINE VARIATION DOE OPTIMIZE
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Process Owners
QA Validations
Engineering
Statistician
Fill Equipment Manufacturer
Customer
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Does your Process Improvement Team have all the key stakeholders?
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Set Up Fill Cap
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Do you really know what makes your Processes Tick?
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No (2) units of final product exactly alike.
KEY: “Vital Few, Trivial Many”
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Key sources of variability
Can reduce variation
Discover optimal equipment settings
Result: final product at target.
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Are you effectively controlling your fill process or is it controlling you?
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Statistically based
Multiple factors
Factor:Factor Interactions
FDA expectation
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Are you using DOE or other statistically based method for process control?
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Factor Unit Level I Level II Level III
Nozzle Height
cm 10 12 14
Operating Pressure
psi 25 30 N/A
Line Speed
Vials/min 200 250 N/A
Response Variable: Average Deviation from the Target Fill Volume
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Source of Variation P VALUE
Model 7.40E-08
A: Nozzle Height 1.18E-09
B: Operating Pressure
3.69E-06
C: Line Speed 0.0001
AB 0.0560
AC 0.6720
BC 0.2490
ABC 0.4870
Results show Effects A, B, C and AB are Significant.
Note: Data for illustrative purposes only. Not actual.
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Best combination of settings:
Nozzle Height = 12
Operating Pressure = 25
Line Speed = 200 Expected fill volume deviation lowest.
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0
2
4
6
8
10
12
Fill Volume Fill Volume Fill Volume Fill Volume
OOS
LSL
Target
USL
OOS2
In- Control
Out-of-Control
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Are you Testing or DESIGNING Quality into your Processes???
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“Save $Millions by Designing Quality into your Systems”, “Transforming Operations to New Heights!” are June Yamada’s passion, with the necessary skills to make it happen with proven results. Over 20 years experience in Medical Device, Pharmaceutical, Clinical Laboratory industries from start-ups to Fortune 500 firms.
Email: [email protected]
http://www.linkedin.com/in/juneyamada
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