Green Belt Presentation - William Birriel

Korsch# 3 Concerta® (Methylphenidate) Increase Tablets Throughput and Reduce

Tablets Waste Green Belt Project

Candidate: William Birriel

D M A II C

Project Team Members

Sponsor: Fernando Reyes Master Black Belt: Patricia Reynoso Core Team Members: Emil Cafaro, Alejandro Hojas, Derek Hansen, Hardarshan Dhindsa, Mike Schrammel, Ramon Diaz

D M A II C

Define Phase

Problem Statement: • Sticky problems during the compression of Concerta 54mg product

in Korsch# 3. • Excessive compression forces variation and out of limits in Layer# 1,

2 and 3 caused by sticky tooling and sticky product during process. • Air nozzle used for rejecting tablets out of tolerances doesn’t

remove sticky tablets in the Take-off area. • Excessive tablet waste caused by sticky tablets, sticky tooling and

compression force variations. • During the year 2014 the following information have been observed

for Concerta® (Methylphenidate) 54mg Cores: Average good cores per lot was 896.4Kg Average waste per lot was 67.1Kg

D M A II C

Business Case

Goal Statement: Increase 2.5 % of the good compression cores on each Concerta 54mg lot by the end of the fourth quarter of 2015. Decrease 20.0 % of tablets waste on each Concerta 54mg lot by the end of the fourth quarter of 2015. Project Impact Estimation: Expected Savings per Lot: $ 1,500.00 Forecasted Savings at the end of 2015: $ 31,500.00

D M A II C

Business Case (cont’d)

Project Wins • Increase Good Cores from 896.5Kg to 916.5Kg average per lot

• Reduced Cores Waste from 67.1Kg to 47.1Kg average per lot

Context • Increase 20Kg of cores per lot means a estimated saving of

$1,500.00 per lot and an estimated forecast saving per year of $31,500.00 prove Concerta 54mg Compression process efficiency

D M A II C

Project Charter

D M A II C

BUSINESS EXCELLENCE

Project Charter

Project Name Korsch# 3 Concerta Tablets Throughput Increase and Tablet Waste Reduction

Products Impacted (if applicable) Concerta

Area OROS Company & Plant Location JSC Vacaville CA

Sponsor Fernando Reyes Telephone Number 707-453-6464

Master Black

Belt

Patricia Reynoso Telephone Number

Core Team

Members

Emil Cafaro, Alejandro Hojas, Derek Hansen, Hardarshan Dhindsa,

Mike Schrammel, Fernando Reyes, Ramon Diaz

Start Date 1/12/15 Target Completion Date 06/01/15

Description

1. Project

Description

(Purpose-of-Process

statement needs to be

included)

Sticky problems during the compression of Concerta 54mg product in Korsch# 3.

Excessive compression forces variation and out of limits in Layer# 1, 2 and 3 caused by

sticky tooling and sticky product during process. Air nozzle used for rejecting tablets out

of tolerances doesn’t remove sticky tablets in the Take-off area. Excessive tablet waste

during sticky tablets and product issues.

2. Process Scope &

Project Scope

The scope of this project is to minimize sticky tablets issues in Korsch# 3 with Concerta

54mg product. With the improvements we will maximize tablet waste reduction and we

will increase good tablets throughput in Korsch# 3.

3.Project Goal (tie metrics back to

purpose statement)

Outcome

Metrics

Process

Metrics

Current Goal Results

Minimize Tablet Weight Variations

Minimize Sticky Tooling Issues

Improve Press Rejection System

Good Cores

Waste Cores

896.5 Kg

67.1 Kg

920.0 Kg

40.0 Kg

4. Business Results Reduce tablet waste during process, Increase tablet throughput or good cores on each Concerta

54mg lot, upgrade rejection system mechanism to increase the efficiency of the rejection system and monitor progress.

5. Team members Emil Cafaro, Alejandro Hojas, Derek Hansen, Hardarshan Dhindsa, Mike Schrammel, Fernando Reyes,

Ramon Diaz

6. Support

Required

Supervisor support will be needed to ensure tasks are completed by qualified operators and

ensure all procedures are being followed. The Kaizen team will employ tasks to collect data and receive input from involved departments accordingly.

BUSINESS EXCELLENCE

Project Charter - Korsch# 3 Concerta® (Methylphenidate) Increase Tablets

Throughput and Reduce Tablets Waste

Project Description: During the compression of Concerta 54mg product in Korsch# 3 sticky tooling and product occurs causing excessive compression forces variation and out of limits in Layer# 1, 2 and 3 creating excessive tablets waste. In addition the air nozzle used for rejecting tablets out of tolerances doesn’t remove sticky tablets in the Take-off area.

Project Scope: The scope of this project is to minimize sticky tablets and tooling movement issues in Korsch# 3 with Concerta 54mg product. With the improvements we will maximize tablet waste reduction and we will increase good acceptable cores throughput in Korsch# 3.

D M A II C

SIPOC

S I P O C -Granulation

-Milling

-Blending

-Final Blend

-Cores within Spec

-Cores Outside Spec (Waste)

-Supervisors

-QA Auditors

-Drilling

-Coating

-Oven

-Printing

-Warehouse

Compression Run

Tablet Press Set-Up

Compression

In Process Testing

D M A II C

Process Reconciliation and Process Efficiency

Voice Of Customer

Concerta 54mg Force Variations and

Excessive Waste during Compression

Process in K3

Tablet Weight Variations

Press Rejecting System

Proper Lower Load Cells Forces Reading

Adequate Tablets Rejection out of

Tolerances during compression process

VOC Key Drivers Critical to Quality

Minimum Forces Variation During Process

Minimum Tablets to be Rejected in TOPA

Tooling Behavior and Conditions During Process

Adequate Compression Tooling Measurements

Tooling Maintenance Jobs Done and on Time

D M A II C

Proper Polishing of Die Bores and Tooling Tips

Adequate Tablets Mechanical Rejection at

the exit of the press

Define Summary

D M A II C

Results: Determined the business needs improvements in order to increase average good cores per lot and decrease waste cores per lot in Korsch 3 for Concerta 54mg product.

Tools Used: Project Charter

SIPOC Critical to Quality (CTQ) Tree

WIP Wait Baseline Data

Average total good cores for Concerta 54mg lots manufactured on Korsch 3 between January 2014 and December 2014 is 896.6 Kg per lot.

D M A II C

* October 2014 lot out the standards reflects the sticky tooling, product and weight variations issues during that month

WIP Wait Baseline Data (cont’d)

Average total cores waste for Concerta 54mg lots manufactured on Korsch 3 between January 2014 and December 2014 is 98.6 Kg per lot.

D M A II C

* October 2014 lot out the standards reflects the sticky tooling, product and weight variations issues during that month

Measure Summary

Results: Determined there are opportunities to improve Concerta® average good cores and waste by minimize sticky tablets and lower tooling movement issues in Korsch# 3

• Determined excessive cores waste during compression process • Determined low average good cores during compression process

Tools Used:

Control Charts

D M A II C

Data Collection Plan – Overview

D M A II C

Eleven (11) Concerta 54mg compressed lots in Korsch 3 between January 2014 and December 2014.

Note:

The Compression Process data of the Concerta 54 mg lots was obtained from Master Batch Records and AMI system.

Data Collection (cont’d)

D Measure A II C

Each is collected in AMI. Results from each lot are listed above.

2014 C-54mg Data

Item No Doses Machine Batch No. Tool Set Date

Acceptable

Cores (Kg)

Vacuum/

Filter

Waste

(kg)

Waste

Cores(Kg)

Total

Waste

Theoretical

Yield %

0018283 C-54mg K3 1414548 VK-36 12/11/2014 913.40 24.00 62.36 86.36 92

0018283 C-54mg K3 1412268 VK-36 12/6/2014 932.84 18.88 42.94 61.82 94

0018283 C-54mg K3 1409393 VK-36 11/4/2014 799.36 35.66 131.32 166.98 80

0018283 C-54mg K3 1409392 VK-36 10/22/2014 694.26 28.99 259.74 288.73 71

0018283 C-54mg K3 1409391 VK-36 9/23/2014 956.40 18.74 28.20 46.94 96

0018283 C-54mg K3 1406810 VK-36 9/18/2014 931.30 16.36 45.56 61.92 94

0018283 C-54mg K3 1404738 VK-36 8/6/2014 949.60 15.61 32.62 48.23 95

0018283 C-54mg K3 1403478 VK-36 6/30/2014 960.00 18.78 20.35 39.13 97

0018283 C-54mg K3 1402480 VK-35 5/20/2014 861.74 82.27 32.72 114.99 93

0018283 C-54mg K3 1401434 VK-35 5/14/2014 919.56 38.45 57.55 96.00 92

0018283 C-54mg K3 1401433 VK-35 4/15/2014 942.64 47.87 25.09 72.96 96

D M Analyze II C

Analyze Phase – 5 WHYs What is the best solution to minimize sticky tablets, forces

variations and sticky tooling issues in K3 with C-54mg?

Sticky Tablet Issues Forces Variations Sticky Tooling Issues

Tablets rejection system is not working properly with Concerta 54mg product during compression process in Korsch 3

Excessive force variations, specifically in Layer 1 and Layer 2 during compression process

Sticky tooling issues creates lower tooling movement problems from the Weight Cam area to the Load Cells area

Rejection system has to reject each tablet out of tolerances during compression process but don't reject some tablets

Layer 1 and Layer 2 pre-compress the tablets using only 100N. The lower tooling sometimes not properly touch the load cells

Extrusions found on the lower tooling tips stem and inside die bores creating restriction in the movements of the lower tooling

The rejection air nozzle in the TOPA doesn’t have the strength to send the tablets to the right rejection exit chute area.

Lower tooling in Korsch press move in the Y- Axis by gravity. Any lower tooling movement restriction cause wrong readings

Extrusion issues can be created by abrassion in the tooling tips and/or compression rings in die bores.

Because when sticky tablet are glued with the lower tooling the air blows and pass through the tablet without moving them from the lower tooling

Because the stycky product and sticky tooling issues the gravity movement of the lower tooling is not smooth when the lower tooling touch the Load Cells

The clearance between the die bores and the lower tooling tip diameter are to tight and the problem mostly occurs with new tooling set is used

Rejection system is uses air. Other type of tablet rejection systems uses a mechanical gate to force the movement of the tablet to the right place.

Korsch uses gravity for lower tooling, in other compression machines the tooling are moved by lower cams to improve the movement of the lower tooling

Actual clearance between lower tooling tip and die bore is 0.0014" for a new tooling set. Old tooling sets VK-35 and VK-36 have a clearance of 0.0029"

D M A Innovate & Improve C

Selecting the Solution

1) Problem: Sticky Tablets – At the output of the machine rejected tablets remained

glued in the lower tooling tips at the ejection and rejection point in the TOPA area

(see picture below). The rejection nozzle didn’t have the strength to send the tablets

to the right rejection exit chute which means that tablets out of tolerances could fall

into the good tablets bucket.

Air Nozzle Sticky Tablet in the TOPA



2) Problem: Force Variations – lower tooling in Korsch press move in the Y- Axis by

gravity. The machine has a Load Cell to read forces for Layer 1 and 2. Any lower

tooling movement restriction would cause wrong forces readings. A custom Pull-Down

Cam will be designed and manufactured to help the movements of the lower tooling

during the process reducing load cells false forces readings.

Load Cell Without Pull Down Cam

Excessive Forces Variations

Layer 1

Layer 2

Layer 3

Tooling Moves Down by Gravity



3) Problem: Sticky Tooling – product extrusion in the lower tooling tip straight area.

Elizabeth Carbide inspection indicates die cavities have an extreme amount of

porosity in the compression area. Based on Korsch Operators old tooling sets works

better the new tooling sets. Based on the vendor feedback, the maximum clearance

between lower tip and die bore can be increased to 0.0037”. The Actual clearance

is 0.0014”. Our team decision was to keep the same clearance of our Old tooling

sets VK-35 and VK-36 at 0.0030”, our best reliable tooling sets on site.

Plan & Implement Solution (cont’d)


1) Solution: Sticky Tablets – To minimize or eliminate the future issues with sticky or

glued tablets in the TOPA area, machine software was changed to activate the mean

gate (a mechanical gate in the chute area) for mechanically rejecting the bad

tablets during process. This system is required and used for Multi-Tip tooling so the

machine was updated for a future usage of Multi-Tip tooling.

Mean Gate (Mechanical Rejection Gate)



2) Solution: Force Variations – Any lower tooling movement restriction would cause

wrong forces readings. A custom Pull-Down Cam was designed and manufactured to

help the movements of the lower tooling during the process reducing load cells false

forces readings.

Custom Pull Down Cam Installed

Layer 1

Layer 2

Layer 3

Minimum Forces Variations



3) Solution: Sticky Tooling – Based on feedback by the vendor, the maximum

clearance between lower tip and die bore can be increased to 0.0037”. The Actual

clearance for new tooling is 0.0014”. Our decision was to keep the same clearance

of our tooling sets VK-35 and VK-36 at 0.0030”, our best reliable tooling sets on

site. Based in this improvement an Replacement in Form was completed (WO-

10929571) and the die drawing was updated and changed from 0.2347” to

0.2360” matching VK-35 and VK-36 set of dies measurements.

Implement Solution cont’d


• Sticky Tablets – Air Rejection Nozzle changes to Mean Gate – PLC Upgrade by Korsch Engineers – Completed on April 2015.

– Qualification strategy IOQ and PQ (DS-VAL-91773) – Completed on May 2015.

– SOP updates (DS-WI-19408) – Completed on May 2015.

• Force Variations – Pull Down Cam Design and Implementation – Change Control (CC-263283) – Completed on April 2015.

– Design Drawing Updates (DS-ENG-23322 & DS-ENG-23293) – Completed on May 2015.

• Sticky Tooling - Concerta 15/64” Die Bores Upgrades – Replacement in Kind Form (WO-10929571) – Completed on May 2015.

– New tooling dies with new tolerances arrived on November 2015

Based in the improvements with 15/64” tooling dies (tooling used for Concerta 36mg and 54mg), the decision was to do the same improvements in the 3/16” tooling dies (tooling used for Concerta 18mg and 27mg).

Results

D M A II Control

C-54mg

# Item No Doses Machine Batch No. Date Tool Set Acceptable Cores (Kg)

Vacuum/Filter Waste (kg)

Waste Cores(Kg)

Theoretical Yield %

20 0018283 C-54mg K3 1508781 9/14/15 VK-35 960.00 25.01 30.20 96

19 0018283 C-54mg K3 1507976 8/3/15 VK-44 960.00 39.19 21.30 96

18 0018283 C-54mg K3 1507975 7/29/15 VK-44 960.00 24.40 26.54 96

17 0018283 C-54mg K3 1504721 6/10/2015 VK-36 960.00 36.68 20.08 96

16 0018283 C-54mg K3 1504720 6/5/2015 VK-36 960.00 36.04 21.80 96

15 0018283 C-54mg K3 1504375 5/28/2015 VK-36 946.60 36.66 39.64 96

14 0018283 C-54mg K3 1500231 3/17/2015 VK-35 952.58 23.88 17.58 96

13 0018283 C-54mg K3 1415449 1/25/2015 VK-36 957.96 24.74 25.27 96

12 0018283 C-54mg K3 1414553 1/21/2015 VK-36 943.90 26.36 42.26 95

D M A II Control

Results

Average total good cores for Concerta 54mg lots manufactured on Korsch 3 between January 2014 and November 2015 had increased by 59.1 Kg good

cores more per lot, from 896.6 Kg to 955.7 Kg.

D M A II Control

Results (cont’d)

Average total Waste for Concerta 54mg lots manufactured on Korsch 3 between January 2014 and November 2015 had decreased by 44.1 Kg less

waste per lot, from 98.6 Kg to 57.5 Kg.

D M A II Control

Results (cont’d)

850.00

860.00

870.00

880.00

890.00

900.00

910.00

920.00

930.00

940.00

950.00

960.00

C-18mg C-27mg C-36mg C-54mg

2014 Ave Good Cores

2015 Ave Good Cores

The tooling used for C-54mg is the same tooling used for C-36mg (15/64” diam.). C-36mg received the benefits of the C-54mg tooling improvements resulting in the increment of the good cores and waste reduction for C-36mg product. Same tooling improvements were completed with C-18mg and C-27mg

tooling (3/16” diam.). The graphic above shows Average total good cores for all Concerta products manufactured on Korsch Press between January 2014 and November 2015 had increased.

D M A II Control

Results (cont’d)

Average total cores waste for all Concerta products manufactured on Korsch Press between January 2014 and November 2015 had decreased.

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

90.00

100.00

C-18mg C-27mg C-36mg C-54mg

2014 Cores Waste

2015 Cores Waste

D M A II Control

Results (cont’d)

Forcasted Savings for Concerta 54mg = $157,023.59

Concerta Savings

Item Item Description PL FBP Lots Core Lots Expected

Savings/Lot Forecasted

Savings

9477 OROS Methylphenidate HCl 36mg AG Concerta US 63 32 468.70 14,998.35

9989 OROS Methylphenidate HCl 54 mg AG Concerta US 42 21 7,477.31 157,023.59

9478 OROS Methylphenidate HCI 18mg, US Concerta US 24 12 (536.55) (6,438.61)

12202 OROS Methylphenidate HCI 27mg, US Concerta US 21 11 3,700.80 40,708.78

Total 150.00 76.00 206,292.09

Total Savings for all Concerta products = $206,292.09

Financial Benefits

Goal Statement: • Increase 2.5 % of the good compression cores on each Concerta 54mg lot by the end of the

fourth quarter of 2015. • Decrease 20.0 % of tablets waste on each Concerta 54mg lot by the end of the fourth quarter

of 2015. Results: • Increase of 6 % of the good compression cores on each Concerta 54mg lot by the end of the

fourth quarter of 2015. • Decrease 40.0 % of tablets waste on each Concerta 54mg lot by the end of the fourth quarter

of 2015. Project Impact Estimation: C-54mg Expected Savings per Lot: $ 1,500.00 / Results = $7,477.00 per Lot C-54mg Expected Forecasted Savings at the end of 2015: $ 31,500.00 / Results = $157,023.00

Total Forecast Savings (all Concerta Products) = $206,292.09

D M A II C

D M A II Control

Key Learnings and Continuous

Improvements • Although improvement ideas were focusing in Concerta 54mg in

order to increase the average good cores and reducing the waste, the expectation was to have the same results and benefits with the other Concerta products (18mg, 27mg & 36mg). In order to obtain better results with the other products we should observe each process individually

• Continuous Improvement: – Improve compression penetration points between layers for

smoother movements between lower tooling and load cells. – Improve start-up process using slow speed on turret in order to

minimize waste – Improve cam tracks in order to minimize product in the die table

collected by the vacuum system during process – Stagger breaks between technicians in order to reduce sticky

tooling issues

Green Belt Presentation - William Birriel

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