Team West Pharmaceutical Services

December 12, 2012

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Phase Deliverables

1 • Definition of Customers and their Needs/Wants/Constraints• Project Scope definition refinement• Identification of science and technology relevant to project• Identification of key performance and cost metrics• Initial benchmarking results

2 • Conceptual design to satisfy sponsor’s requirements• Design specifications necessary to purchase components, manufacture, and

assemble the proof-of-concept prototype• Project cost

3 • Conceptual design to satisfy sponsor’s requirements• Design details for solution to sponsor’s project• Updated Project Plan with allocation of needed resources• Updated test plan that is based on a credible set of experiments and uses

valid measurement methodologies

4 • A viable prototype• A transition plan that facilitates the implementation of the project results

into the sponsor’s business

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Phase Deliverables

1 • Definition of Customers and their Needs/Wants/Constraints• Project Scope definition refinement• Identification of science and technology relevant to project• Identification of key performance and cost metrics• Initial benchmarking results

2 • Conceptual design to satisfy sponsor’s requirements• Design specifications necessary to purchase components, manufacture, and

assemble the proof-of-concept prototype• Project cost

3 • Conceptual design to satisfy sponsor’s requirements• Design details for solution to sponsor’s project• Updated Project Plan with allocation of needed resources• Updated test plan that is based on a credible set of experiments and uses

valid measurement methodologies

4 • A viable prototype• A transition plan that facilitates the implementation of the project results

into the sponsor’s business

Background

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• West Pharmaceutical Services is a manufacturer of pharmaceutical packaging and injectable drug delivery system components for pharmaceutical and medical device companies

• RU packaging systems must have at least 3 removable packaging bags to comply with West RU packaging standards

• Ready to use (RU) products have multiple layers of packaging and packaging is shed as it goes through clean rooms prior to use

• Products are sterilized, packaged, and are ready to be used without any further preparations

Current Design - Westar RU for Lyo Stoppers

• 3 layers– Foil (Tertiary)– PE, Tyvek (Secondary)– PE, Tyvek (Primary)

• Primary and secondary bags are autoclaved

• Packaging integrity risks with removing the secondary bag

• Poor ergonomics

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Figure 1: Current primary bag

• To develop an innovative, sterile packaging system that adds value to West’s products and improves customer handling.

Project Scope

Prioritized Sponsor Wants

1 Compatible with steam sterilization (minimum of 122 for ℃60 minutes)

2 Maintain package integrity

3 Durability compared to current packaging: meet ASTM F390 standards for Gelbo testing

4 Meet minimum shelf-life requirements5 Multiple layers that are able to be shed6 Easy to handle

7 Easy access to package contents without compromising packaging integrity

8 Visibility of Package Contents

9 Maintain cost to manufacture10 Aesthetic

Want Target Value (s)

Compatible with steam sterilization (minimum of 122 for 60 minutes)℃

Yes

Maintain package integrity Meets all applicable ASTM standards

Durability compared to current packaging: meet ASTM F390 standards for Gelbo testing 900 strokes with < 7 pinholes

Meet minimum shelf-life requirements 6 months

Multiple layers that are able to be shed > 3 layers

Easy to handle <15 lbs-25 lbs

Easy access to package contents without compromising packaging integrity

Time to remove 1 layer: < 15 seconds

Maintain cost to manufacture $6-$10

Aesthetic 80% of test subjects respond ‘Yes’ to improvement over current design

Verify Contents of Container Visible from outer bag: Yes/No

Metrics

3 Major Categories were considered for Concept Generation

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Non-Rigid Concepts

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• 3-Layers composed of PE / Tyvek.• Heat-sealed.• Ripcord opening method.

• 3-Layers composed of PE / Tyvek.• Handles on each layer.• Heat-sealed.

Updated Sponsor Wants

1 Compatible with steam sterilization (minimum of 122 for 60 minutes)℃

2 Maintain integrity

2.5 Rigid

3 Durability compared to current packaging: meet ASTM F390 standards for Gelbo testing

4 Meet minimum shelf-life requirements

5 Multiple layers that are able to be shed

6 Easy to handle

7 Easy access to package contents without compromising packaging integrity

8 Visibility of Package Contents

9 Maintain cost to manufacture

10 Aesthetic

3 Variations of Rigid Containers were Considered

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Rigid Tertiary Container

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• Outer container – Rigid PE/Tyvek

• Primary and secondary deformable PE/Tyvek bags inside

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Initial Rigid Primary Container Concepts

Figure 1: Ripcord Figure 2: Access Hole

Figure 3: Peel-able Heat Seal

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Selected Model for Prototype: Primary Container

Final Prototype

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Figure 4. Final primary container design.

Heat-sealed Tyvek® 1073B

with 24AL Xhale® adhesive top

Makrolon GP Polycarbonate rigid container

• Prototype container can hold roughly 4,500 Lyo stoppers

Final Prototype

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Figure 5. Final packaging system featuring 2 removable layers around a rigid primary container.

• Primary container surrounded by Tyvek/Polyethylene secondary bag• Secondary bag surrounded by a Nylon/Polyethylene tertiary bag• Secondary bag vacuum-sealed around primary container to conform

outer bags to primary container for improved ergonomics

Budget Breakdown

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TOTAL BUDGET: $10,000

Test Materials $400

Manufacturing Cost $3,500

Initial Fees $1,500

TOTAL COST $5,400

Testing

• Preliminary Tests: (6) 1”x11” Polycarbonate samples– Tension– Peel– Material Integrity

• Final Testing: Final prototype– Stacking– Material Integrity– Peel

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Testing

• Preliminary Tests: (6) Polycarbonate samples per test– Tension– Peel– Material Integrity

• Final Testing: Final prototype– Stacking– Material Integrity– Peel

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Tension Testing of Polycarbonate Specimens

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• Prepare Specimen to height and thickness dimensions of final container with arbitrary width.

• Reduce load displacement data to obtain stress and strain information.

• Extrapolate stress results to determine maximum stacking load of the final container.

• After the required autoclave cycle, strength increased by ~10%

Tyvek / Polycarbonate Interface Peel Strength Test

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• Prepare Specimens of Polycarbonate and Tyvek to equal but arbitrary dimensions.

• Bond Tyvek to Polycarbonate as instructed by PacTech.

• Measure force to separate Tyvek layer from polycarbonate with instron testing machine.

• Determine strength to peel based on area of sealant.

• Minimum Peel Strength was determined to be 3.3lbf/in

Steam Autoclave Material Integrity Test

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• Prepare Specimen to arbitrary dimensions.• Measure Dimensions of Specimen with caliper.• Place specimen in autoclave and run at specified

cycle.• After run is complete, measure sample and

document and changes.• Vary orientation of specimens in autoclave.

Sample #

Averaged Width

(in)

Averaged Thickness

(in)

Length (in)

1-7 1.048 0.089 11.880 Before Autoclave

Sample #

Averaged Width

(in)

Averaged Thickness

(in)

Length (in)

1-7 1.046 0.089 11.894 After Autoclave

• No relevant change in geometry due to the required autoclave cycle

Testing

• Preliminary Tests: (6) 1”x11” Polycarbonate samples– Tension– Peel– Material Integrity

• Final Testing: Final prototype– Stacking– Material Integrity– Peel

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Stacking Test

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• Stacking tests resulted in a maximum stacking load of 110 lbf

Material Integrity Test – Steam Autoclave

Still to be performed

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Thermoform vs. Injection Molding

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Example quote from Advanced Plastics, NY

Attribute Thermoform Injection Mold

Mold fabrication time 4-6 weeks 18-24 weeks

Parts per year (per mold) 250-3000 Up to 100,000

Cost of mold $ 3,000 $ 22,000

• Thermoform was best choice for a rapid prototype with reduced prototyping costs

• Costs would have been ~7x more and not been delivered until mid-February

• For actual production of larger unit numbers, injection molding is obvious choice.

Path Forward

• On production of >10,000 parts, Injection Molding is recommended as process choice.– Faster production time– Cheaper per part cost– Less downtime as mold lasts for more cycles.

• Opinion of group that trays were thicker than needed, future optimization of dimensions would drive materials cost down.

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Number Produced Materials Cost Process Cost Tooling Cost Total Cost50000 2.88 0.93 3.34 7.15

100000 2.88 0.93 1.95 5.76500000 2.88 0.93 0.5 4.31

*Model used to produce costs assumed 2.00$ / lb material (medium engineering grade). Actual research shows an expected 1.60$ / lb Polycarbonate.

• Estimated costs (using Injection Molding calculator from University of Massachusetts) shown below in table. Based on empirical data.

Path Forward (Testing Next Steps)

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Samples Processed and Subjected to Simulated Distribution Conditioning

•Run autoclave sterility cycle per current procedure•Visually inspect seals for gross defects per ASTM F1886.

•Subject filled cartons to simulated distribution conditioning per ASTM 4169-09, Distribution Cycle 2 (single parcel).

Schedule A Manual Handling-First Sequence SetSchedule B Vehicle Stacking-CompressionSchedule F Loose Load Vibration, Method A1- Truck 40 minSchedule E Vehicle Vibration- Truck 30 minutes, Air 120 minutes, Truck 30 minutes (column stacked)Schedule A Manual Handling- Second Sequence SetSchedule I Low Pressure- 14000ft f0r 60 minutes

•Perform integrity testing on package system:Visually inspect seals for gross defects per ASTM F1886.If there are any questionable seals, use methylene blue dye penetration to confirm seal quality (per ASTM 1929)Perform integrity testing via vacuum decay testing (ASTM F2338) or other suggested method.

Acknowledgments

West Team•Mark Launer•Tim Miller•Monica Habash

Pactech•Frank Colombo•Chad Buchta

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UD•Dr. Buckley•Jim Farmer•Center for Composite Materials

Questions?

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