Transcript Group 11 Terumo Cardiovascular Systems

Terumo Cardiovascular Systems
Viable Lean Manufacturing Solutions for the Oxygenator Production Line
Lou Peticca
Doug Bair
Ed Bottomley
Jen Egolf
Mike Washko
Dr. Glancey
Greg Hayes
Brett Entrekin
Miles Thackrah
Steve Rendulic
Current Process
Vacuum Leak Test
Existing Machine
• Time Duration is Too Long
• Can be completed with less
personnel
Current Process
Label and Pertinent Part
Optical Sensors
• System Satisfactory
Assembly Stand
• Awkward to Use
• Lots of Manual Labor
Design Requirements
►
Reduce Machine Process Time
►
Be Compatible with all 4 HE-OX and Reservoir Combinations
►
Perform Leak Test
►
Sense for Pertinent Parts and Labels
►
Aid in the Assembly of the Oxygenator
►
Ergonomically Friendly
►
Safe
►
Compatible with Class 100,000 Clean Room Requirements
►
Include PLC Motion Control
Final Concept Selection
Dual Angled Stationary Leak Tester
How it Works
►Demo
Reservoir is Placed into Cradle Support
 HE-OX is Assembled onto Reservoir
 HE-OX is Rotated into Correct Position for Shipping Purposes
 Connecting Ring is Put into Place
 Clamping Arm Secures Connecting Ring
 Assembling the Two Units Together
 Start Machine by Pressing go on Touch Screen
►
Actuators Block Open Ports and Vacuum Test Begins
►
Sensors Detect Labels and Pertinent Parts
►
Sensors and Actuators Retract, and Completed Unit is Removed
Final Design
Subsystem 1
Clear Cast Acrylic
Doors
Table Design:
►ERGONOMICS
Applied science concerned with
designing equipment that people
use so they can work safer and
more efficiently
►STURDY DESIGN
Support a large amount of weight
Manufacture frame out of Steel
►EASE OF USE
Display Touch Panel
Doors access leak testing
machines
Shelf/Cubby for remaining HE-OX
fixtures
Bottom Shelf Layout
►
This table must support
the our design solution:









Fixtures
Actuators
Sensors
Leak testers
PLC/Electrical Board
Pumps
Buffers
Display panel
Shelf
1016 mm
Completed Table
Frame: 50.8 mm x 50.8 mm (3.18 mm inner wall thickness) – 1045 Carbon Steel
Table Top: 1159 mm x 1000 mm x 8 mm - 304 Stainless Steel
Side Panels and Bottom Plate – 1045 Carbon Steel
Final Design
Subsystem 1
Clear Cast Acrylic
Doors
Reservoir and HE-OX Combinations
SX 25 HE-OX
Reservoir 1
Reservoir 2
Reservoir 1
Reservoir 2
SX 18 HE-OX
4 Combinations
SX 10 HE-OX
SX 25 HE-OX
SX 18 HE-OX
SX 10 HE-OX
Interchangeable HE-OX Support
HE-OX Support
Reservoir Support
HE-OX Rotation Stop
Features
Three HE-OX Support blocks to use with the four combinations of
HE-OX’s with Reservoir.
►
PLC Sensors sense Holes in block to know which combination is in
use.
►
►
Rotation Stop ensures HE-OX is in correct orientation for shipping.
Reservoir Support ensures Reservoir is fixed in position during the
workstation process.
►
HE-OX Support ensures correct positioning and ease of assembly
during workstation process.
►
Cradle Support
► Bottom
Cradle
► Back Bumper
► Side Skids
► Peg Supports
Bottom Cradle and Back Bumper
► Cradle
 Shaped for Reservoir 1
►
Side Skids
 Lead-in for Reservoir
 Provides support from
the sides
 Holds the side pegs in
place
► Bottom
Bumper
 A stop for Reservoir
Peg Supports
► Made
to fit into the
holes in the lid
► Provides good support
Holes
Final Design
Subsystem 1
Clear Cast Acrylic
Doors
Reservoir Plug Actuators
► Required
for vacuum check
► Plugs needed for:
 Reservoir Blood Out Port
 Reservoir Vent Port
 Two Ports on Venus Inlet Port
Sensors Required
► Sensors
Required for:
 3 Reservoir Labels
 2 HE-OX Plugs for Blood-In and –Out Ports
 Connecting Ring between HE-OX and Reservoir
Concept Validation
Delrin Part Changeover Check
Oxygenator Fit Check
Overall System Fit
Check and
Ergonomic Fit
Check
Final Budget
Subsystem
Total Cost
Delrin Fixtures
$3005
Table
$6526
Electronics/
Sensors/Actuators
Other Costs
$10257
Total
$19,817
$28
Project Summary
Completed:
►
►
►
►
►
8 Delrin Base Plates were Designed, Machined, and Tested
2 Delrin Cradle Supports were Designed, Machined, and Tested
All Sensors and Actuators have been Specified and Ordered
Table and Table Top have been Designed, Fabricated, and Tested
PLC Components have been Specified and Ordered Including a Detailed PLC Flowchart
To Do:
►
►
►
►
Code and Debug PLC Program
Wire and Install all Actuators and Sensors
Add Touch Screen-User Interface
Perform Completed System Validation
Transition Plan
► UD
Senior Design and Terumo
 Complete Machining of All Components
 Begin Implementation of Actuators and
Sensors
 Final Table Top to Table Assembly
► Recommendations
for Terumo
 Fine Tune PLC and Safety Mechanisms
 Continue Implementation of Actuators
and Sensors
 Incorporate Workstation into Production
Acknowledgments
►
►
►
►
►
►
►
►
►
►
Dr. Glancey
Lou Peticca
Doug Bair
Ed Bottomley
Jen Egolf
Mike Washko
Jeff Bupp (Sheet Metal Fabricators)
Ted Berling (BSMW)
Steve Beard
UD Engineering Office
THANK YOU
QUESTIONS?
Gantt Chart
Gantt Chart
Team :11 Terumo Cardio Cardiotomy Leak/Assembly Machine
6-Sep 13-Sep 20-Sep 27-Sep
Project Definition
Consumer Wants and Needs
Benchmarking
Concept Generation
Concept Selection
Concept Design
Top Fixture Frame Design
Bottom Fixture Frame Design
Table Design
Sensor Placement
Actuators Placement
Leak Tester Design
Parts Tester Design
Completed Parts List
PLC Programming Flow Chart
Assembled Table Design
Table Top Safety Guard
Self Safety Guard
Machine Build
Fixture Frame Build By Machinist
Top Fixture Frame Assembly
Bottom Fixture Frame Assembly
Table Frame Build
Attach doors to Table
Table Top Build
Sensor Order
Actuators Order
Leak Tester Order
Remaining Parts Order
Leak Tester Assembly
Parts Tester Assembly
Completed Table Assembly
PLC Programming
Testing
Fixture Frame Fit test
Test for Quick Change Over
Safety Test
Time of Use Test
Parts Tester Demonstration
Running of PLC Programming
Sensor test
Actuator test
Leak Tester Demonstration
Completed Design test in current
manufacturing process
Path Forward/Redesign
Table Top Redesign
Top Frame Redesign
Bottom Frame Redesign
Drill more holes on the Table Top
Attach Sensors, Actuators, and Pneumatics
4-Oct
11-Oct 18-Oct 25-Oct 1-Nov 8-Nov 15-Nov 22-Nov 29-Nov 6-Dec
13-Dec and onwards
Concept 1
Continuous Motion Leak Tester
Station 1: Assembly
Station 2: Leak and Label Testing
Station 3: Removal from Station
Project Definition: Implement lean manufacturing techniques to
streamline the cardiotomy reservoir assembly process, more specifically
the leak test station, by creating a stand alone apparatus to match or
exceed the necessary cycle time of the area as well as assist assembly of
the device and check for the presence of relevant parts via electric
sensors.
Concept Selection
All Concepts were compared to the wants and constraints and the
best fitting concept was then selected.
Concepts were then modified through discussions with the Terumo team
and the final concept was selected.
Concept 2
Dual Pneumatic Stroke Leak Tester
This concept uses two fixtures, which will move by
means of pneumatics, and the two fixtures will be out
of phase to cut back on lag time.
Proximity Sensors
►3
proximity sensors will be necessary to
check which fixture is in the workstation,
either the SX-10,18,25 or the reservoir only
system.
 PLC will take data from these sensors to
activate correct sensors and actuators.
Other Electronics and Pneumatics Considerations
►A
modular PLC has been chosen that has
expandability in regards to input and output
modules
► System will also require at least five
solenoid valves to differentiate between
actuators for different products
 Valves will be controlled by PLC
Concept 3
Dual Stationary Leak Tester
This Concept uses two stationary stands to hold and
secure the Oxygenator during assembly and testing.
Concept 4
Dual Angled Stationary Leak Tester
• Uses gravity to hold HE-OX into place during assembly.
• Stationary stand simplifies machine during testing.
Time Line of Process
Wants and Constraints:
Needs
•Unit must be safe for the operator to use
•Less work for operator
•Faster production cycle time
•Allow for different size reservoir
•Able to attach the HE-OX to the reservoir
•Create a holder which will not scratch or
damage the product
•Assemble so parts are in correct position
for packaging
•Use machine parts that can be used in a
clean room environment
•Intuitive to use
•Indicator of missing relevant parts
•Perform the leak test
•Accessible for maintenance work
•Change over for different size reservoir
time is less than five minutes
•Completion of project by early December
Wants
•Extremely simple to use
•Appeasing to the eye
•Improve evacuator machine leak test time
•Comfortable to use
•Thermo isolator attached before
assembly of the HE-OX to the reservoir
•Even smaller floor area
Benchmarking and Metrics
Concept Selection
Customer Wants
PLC Flow Chart
Operator
places
reservoir
into
machine.
Operator
places
HE-OX
onto
reservoir
and
machine
Operator starts
machine
PLC checks Safety
Light Curtain for
no breaks
Go/NoGo
GO
PLC looks for
fixture (SX10,18,25)
NO GO:
Machine Stop
Sensors check for 3
labels and 2 plugs
PLC logic determines
if oxygenator passed
or failed
Pass: Green light
is displayed
Operator
removes
oxygenat
or and
moves it
to next
process
table
PLC receives
data from
sensors and
Vacuum
Check
Fail: Red Light plus
Fault indicator on
screen
Operator
removes
oxygenator
and places it
on product
fail table
Operator
places
connector
ring onto HEOX/Reservoir
assembly
Operator
operates
connecting
ring clamp
to finish
assembly
PLC activates correct sensors
and actuators based on
previous step
Actuators move correct
sensors and plugs into
position.
Air is evacuated from
reservoir for leak check
Adjustable Table
►The
table height should
adjust to different sized
operators.
Crank
Pneumatic Cylinders and
Wedges
Adjusting Feet
Polypropylene Base
Housed in Nickel-Plated
Steel
Adjustable to a maximum
of 6 inches
Supports the weight of
the table
►Our final desired working
table height is 40 – 46 inches
C=6
ERGONOMICS
► Repetitive
process:
 2-3 cycles/min
 8 hour work day
► Occupational
Safety
and Health
Administration
guidelines:
 Elbow height is the
desired working height
for a standing process
► 5th
percentile of women’s
elbow height= 36 inches
► 95th percentile of men’s
elbow height= 49 inches
Venus Port Support
► What
if the Venus Port
is out of Place?
► Design to catch the
port if close
► If not close the
reservoir will not fit
Venus Port
Sensors
► One
stationary sensor embedded in the
reservoir cradle that will sense for middle
label.
► Two 90 degree sensors on each side to
check for side labels (one sensor on each
side for each reservoir type)
 Sensors for smaller SX-10 will be on actuators.
Plug Actuators
► Pneumatic
Out Port
slide table for Reservoir Blood
 Also needs two compact linear actuators to
adjust between two reservoir sizes.
► Combination
of slide table and standard
linear actuators to block off Vent Port
► One standard linear actuator to block off
each of the ports on the Venus Inlet.
Sensors Continued…
► One
stationary 90 Degree sensor to sense
for plug on HE-OX blood-in port
► One sensor to check for presence of
connecting ring
► Three light beam sensors to check for plugs
on HE-OX blood-out port
 Sensor detects plug presence if light beam is
broken.
Path Forward
► Order the necessary parts
► Contract machinist to build our parts
► Start the Assembly of the ordered parts
► Assemble the workstation
► Begin testing







Sensors
Actuators
Leak Tester
Parts Tester
PLC Programming
Frame
Completed Table
Testing
►
HE-OX and Reservoir Support Fit Test
 Assure the proper fit of all units into workstation
►
Pneumatics and Actuator Testing
 Assure no entanglement/interference between actuators/sensors and
product part
 Assure leak test is calibrated properly
►
Sensor Test
 Assure sensors are properly calibrated and can detect a “bad” unit
►
Test Safety Feature of Workstation
 Light Curtain
 Ergonomic constraints
►
Final Testing
 Assure all subsystems interact correctly
 Verify all metrics are met (Operator Lag Time)