Use Process Analytical Technology PAT and Quality by Design QbD to speed up development, improve quality and increase profits.

1. EOSWISS Engineering Sàrl
Innovation - Process Excellence - Business Development
Increase Profits
With
Process Analytical
Technologies
EPHJ - SMT - 2015 «Innovation and Process Excellence» Conference
Genève 3. June 2015
Dr.Georg Astl

2. 1. Legal Requirements
• FDA
2. Quality by Design
• Efficient Development
• Lower costs at Registration
3. Process Analytical Technology
• Higher Profits through better quality
Summary
2

3. 3
“a system for designing, analyzing and
controlling manufacturing through timely
measurements (i.e. during processing) of
critical quality and performance attributes of
raw and inprocess materials and processes,
with the goal of ensuring final product
quality”
FDA, 2004
FDA

4. 4
Quality by Design
Systematic variation of relative concentration of Component A and
pressure (= B)
Pressure B
Relative concentration component A
The most efficient lay out!

5. 5
Quality by Design
Design Space can be used for registration.
Process variation inside the design space – NO Process Change
Large Cost advantage during the years of production

6. 6
Process Analytical Technology
12 online sensor example
Classic
Situation
Sensor
Output
Totally
12
Sensors
Is it
OK
???

7. 7
Process Analytical Technology
Multivariate Analysis – Principal Component Visualization 2
Dimensions. Process instabilities corrected immediately.
No claims! No costs!
Instability in the
process
is seen easily!

8. 8
Process Analytical Technology
Multivariate Analysis – Principal Component Visualization 3
Dimensions
On - line Process Control :
Instability is corrected immediately! No claim! No Cost!

9. 9
0
20
40
60
80
100
120
Turn over and
profit
Re-work and
claims
Turn over and
profit
Profit
Claims
Turn over
+ 10 %
increase in
profit
1% of re-
work and
claims =
10% of
profit
Process Analytical Technology

10. 10
• FDA requires Process Analytical
Technology
• “Quality by Design” = Cost reduction at
Registration stage
• Process Analytical Technology: Improve
profit through better quality!
Summary