Honeywell PowerPoint template 2019...HB PVdC up to 13.6% thicker than Pentapharm Aclar at comparable...

DISCLAIMER

Although Honeywell International Inc. believes that the information contained herein isaccurate and reliable, it is presented without guarantee or responsibility of any kind and doesnot constitute any representation or warranty of Honeywell International Inc., whether expressor implied. A number of factors can affect the package performance, such as packagingdesign, film type, forming equipment and process conditions, and verification process. The listof recommendations for assessing the optimum package design and performance is notintended to be exhaustive, and customer or technical support provided by Honeywell isgratuitous in nature and offered without any warranties or representation. Nothing presentedherein shall relieve the user from the responsibility of carrying out its own assessment,verification, or safety protocols and the user assumes all risks and liability for the use of thisinformation (including, but not limited to, risks relating to results, patent infringement,regulatory compliance and health, safety and environment) related to the use of the productsand suggestions contained herein.

PROTECTIVE BLISTER PACKAGING MATERIALS: ACLAR® THOMAS DRIES Amsterdam October 15, 2019

ROADMAP

What is Aclar?

Moisture Barrier ConceptAclar film rangeFlat-film MVTR & barrier

Impact of FormingWeight gain testing of blistersEstimating formed cavity MVTR

Benefits & Value Prop.Aluminum / AluminumHigh Barrier PVdC

Measurements vs MVTR EstimatesWeight gain testing results versus per cavity MVTR estimates

HoneywellHow & where it is madeKey features

HONEYWELL | GREAT BUSINESSES IN GROWINGINDUSTRIES

Positive Macro Trends Underpin Our Businesses

Aerospace

Home and Building Technologies

Performance Materials and Technologies

Safety and Productivity Solutions

• Comprehensive Connected Building offering improving performance and efficiency

• Broadening software and services opportunities

• Connected Plant enhancing customer operations• Solstice® low-global-warming products reduce

carbon emissions across many industries• Aclar® moisture barrier films

• New, innovative product launches in Productivity business

• Piloting Connected Worker with numerous customers

Segment

• Big wins on the right aircraft• Largest installed base in the industry…and growing~$15.5B

~$9.3B

~$10.7B

~$6.3B

Our products are used on virtually every commercial and defense aircraft platform and in

100M+ vehicles worldwide and include aircraft propulsion, cockpit systems, satellite

communications, and vehicle turbochargers.

Our products, software and technologies are in more than 150 million homes and 10 million buildings worldwide helping customers control their comfort,

security, and energy use.

We develop advanced materials, process technologies, automation solutions, and industrial

software that are revolutionizing industriesaround the world.

We improve enterprise performance and worker productivity and safety with our scanning and mobile computers, software, warehouse automation solutions,

and personal protective equipment.

Sales Our Business Why We Win

ACLAR® FILM

Poly-Chloro-Tri-Fluoro-Ethylene

Aclar (PCTFE) is a crystal clear, bio-chemically inert,

chemical resistant, plasticizer and stabilizer free film.

It provides the highest moisture barrier per thickness of any

thermoformable films.

F Cl n

Aclar® Laminate Blisters

Starts as Fluorspar CTFE Monomer AclonTM Resin

Film Extrusion and Slitting

Lamination to PVC, PETG,or other polymer films

AclonTM Pelletization

Honeywell’s Convertor Partners

ROADMAP

What is Aclar?

ACLAR® RANGE OF FILMS

High Barrier Ultra High BarrierMedium Barrier

il / 2

il / 7

il / 1

• For moisture-sensitive drug products in all climatic zones

Portfolio designed to meeting wide range of barrier needs

ACLAR® RANGE OF FILMS

High Barrier Ultra High BarrierMedium Barrier

il / 2

il / 7

il / 1

Portfolio designed to meeting wide range of moisture-barrier needs

il / 1

NEW!NEW!

MVTR (FLAT-FILM) @ ICH TESTING CONDITIONS

MVTR pattern at different ICH testing conditionsSource: Honeywell Aclar Datasheets

MOISTURE VAPOR TRANSMISSION RATE

Moisture Vapor Transmission RatePermeability

2 mil 4 mil 6 mil

Moisture Vapor Transmission Rate X Gauge-1

Permeability-1

At constant T & RH “Moisture Barrier” should be proportional to film gauge

Get started with flat Aclar film MVTR

Aclar UltRx2000 Aclar UltRx4000Aclar UltRx6000

Moisture Vapor Barrier Increasing gauge (barrier) by a factor of N reduces MVTR by a factor of 1/N

BARRIER PERFORMANCE ACLAR AND ACLAR ACCEL FILMS

Aclar Accel

Aclar Rx

Flat-Film Moisture Vapor Barrier is predictable & proportional to film gauge

ROADMAP

What is Aclar?HoneywellHow & where it is madeKey features

Measurements vs MVTR EstimatesWeight gain testing results versus Per cavity MVTR estimates

Duplex• Asymmetrical structure

‒ Aclar moisture barrier ‒ Web carrier such PVC, PP, PETG

Triplex (and Quadruplex)• Symmetrical structure

‒ Aclar moisture barrier ‒ Two outer layers such PVC , PP, COC, PETG

• Asymmetrical structure‒ Aclar moisture barrier ‒ Web carrier such PVC, PP, COC, PETG‒ Oxygen barrier layer such EVOH‒ Other functional layers such as PE

COMMON ACLAR®- LAMINATES

IMPACT OF FORMING

Formed cavity MVTR critical for drug product stability

• Creation of greater surface S(cavity)• Reduction of film thickness d(cavity)• Reduction in barrier• Thickness distribution of the barrier layer over

entire surface area*

Options to assess MVTR (cavity)1. Measurements (i.e. weight-gain)2. Estimates via “Barrier Calculator”3. (Finite-Element-Analysis FEA)*

* Refer presentation Daniel Stagnaro KP

Microtome Cut – Honeywell Labs

Blister produced with Klöckner Pentaplast’s Pentapharm® Aclar PA200 /02 laminate

Cut – Direction

Ultrx2000

WEIGHT-GAIN TESTING – SIZE #1 CAPSULE

Example of weight gain testing according to USP 671

40°C / 75%RH

S (cavity) = 452.8 mm²

Draw Ratio = 2.344S(base) = 193.2 mm²

TYPICAL WEIGHT-GAIN TESTING PROTOCOL*

Weight Gain (g/package)Day 6 Day 7 Day 13 Day 20 Day 27 Day 34 Day 37 Day 58

1 0.00580 0.00650 0.01092 0.01574 0.02028 0.02518 0.02726 0.04195

2 0.00576 0.00643 0.01088 0.01564 0.02028 0.02507 0.02702 0.041693 0.00595 0.00674 0.01141 0.01645 0.02134 0.02640 0.02854 0.04400

4 0.00574 0.00656 0.01095 0.01603 0.02113 0.02605 0.02803 0.04317

5 0.00570 0.00631 0.01073 0.01568 0.02039 0.02522 0.02720 0.04196

6 0.00559 0.00638 0.01085 0.01567 0.02052 0.02548 0.02746 0.04231

Average 0.00576 0.00649 0.01096 0.01587 0.02066 0.02557 0.02759 0.04251

Std. Dev. 0.00012 0.00015 0.00023 0.00032 0.00046 0.00054 0.00058 0.00089

Variation 2.1% 2.3% 2.1% 2.0% 2.2% 2.1% 2.1% 2.1%

Need to pay attention to - Variation between samples- Aberrant data pointso - Saturated desiccanto - Faulty samples

Size#1 capsule packed in Pentapharm® Aclar PA200 run with plug-assist

A minimum of 6 blister cards recommended for weight-gain testing

* In accordance with USP 671

BARRIER CALCULATOR - EXAMPLE

MVTR of formed blister increases quadratically with surface area formed

𝒅𝒅 𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄 =𝑺𝑺 𝒃𝒃𝒄𝒄𝒃𝒃𝒃𝒃𝑺𝑺 𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄𝒄

∗ 𝒅𝒅(𝒇𝒇𝒇𝒇𝒄𝒄𝒄𝒄𝒇𝒇𝒄𝒄𝒇𝒇𝒇𝒇)

Assumption: Aclar-thickness in cavity is constant and scales with draw ratio

Draw Ratio = 2.344

𝑫𝑫𝑫𝑫𝒄𝒄𝑫𝑫 𝑹𝑹𝒄𝒄𝒄𝒄𝒄𝒄𝑹𝑹−𝟏𝟏

S(base) = 193.2 mm²

UltRx4000

S (cavity) = 452.8 mm²

MVTR(cavity) = 𝑺𝑺 𝒃𝒃𝒄𝒄𝒃𝒃𝒃𝒃 ∗ 𝑴𝑴𝑴𝑴𝑴𝑴𝑹𝑹 𝒇𝒇𝒇𝒇𝒄𝒄𝒄𝒄𝒇𝒇𝒄𝒄𝒇𝒇𝒇𝒇 ∗ 𝑫𝑫𝑫𝑫𝒄𝒄𝑫𝑫 𝑹𝑹𝒄𝒄𝒄𝒄𝒄𝒄𝑹𝑹𝟐𝟐{mg/mm²/day}{mm²}

193.2 mm²

452.8 mm²

{mg/day}

102µm

43.5µm

ROADMAP

What is Aclar?

Good correlation of weight gain testing results with estimates

PER CAVITY MVTR - MEASURED VS CALCULATED Size#1 capsule run with plug-assist and weight-gain-tested by Honeywell @ 40°C/75%RH

MVTR (mg/cavity*day) @ 40°C/75% RH

UltRx2000 UltRx4000 Accel5400 UltRx6000

wt.-gain Calc. wt.-gain Calc. wt.-gain Calc. wt.-gain Calc.

0,103 0,108 0,058 0,051 0,04 0,036 0,037 0,032

Deviations measured vs estimated are in the range of -5% - +13.5%

mg/cavity/day

Draw Ratio = 2.344

Measured (L) vs Calculated (R)

PER CAVITY MVTR - MEASURED VS CALCULATED

Decent correlation of weight gain testing results with estimates

MOISTURE BARRIER OPTIMIZATION CASE-STUDY

Optimized tool design resulted in 34.6% higher barrier (25.7% lower MVTR)Need to be very mindful about cavity design - in particular for low dosage strengths & small tablet sizes which tend to be more vulnerable against moisture ingress

ROADMAP

What is Aclar?How & where it is madeKey features

Example: Size 0 capsule

Cavity Surface Area: 62% less

Blister Footprint: 55% less

PACK-SIZE COMPARISON ACLAR/PVC VS ALU-ALU

Up to 55% reduction in area & 62% in volume, respectively

BENEFITS THERMOFORMING VS ALU-ALU

ASAP-study to compare shelf-life Aclar/PVC vs Alu/Alu advised

Reduction of- Pack Weight- Pack Volume- Shippping cost

- Patient discretion- Ease of extraction- Portability- Longevity (Robustness)- Less Medication Errors Higher Patient Adherence

Gains in - Productivity- Capacity- SpaceReductions of - Total Cost

HB PVdC up to 13.6% thicker than Pentapharm Aclar at comparable flat-film MVTR

100 µm25 µm

108 µm25 µm

100 µm

254 µm

25 µm72 µm

HB PVdC Range *

Aclar UltR2000

254 µm

51 µm

PA200 /02PVC

351µm

358µm

309µm

100 µm25 µm

144 µm25 µm

100 µm

394µm

Pentapharm®Aclar®**

Aclar UltRx4000 101 µm

363µmPA400 SO3

127 µm

Aclar UltRx3000PVC

338µmPA300 SO3

76 µm

127 µm

~ 6 layers

PENTAPHARM ACLAR/PVC VS HB PVDC

+13.6%

~ 9 layers

~ 12 layers

*Marketed HB PVdC-Films ** Pentapharm® is a registered trademark of Klöckner Pentaplast

Significantly lower haze & no yellowing HB Aclar/PVC vs HB PVdC

HB ACLAR/PVC VS HB PVDC HB Aclar/PVC

51µm 76µm 102µm 120g 180g 360g

120g "2000" 180g "3000" 360g "4000"

Haze (fresh L & aged R)

fresh aged

120g UltRx2000 180g UltRx3000 360g UltRx4000

Reduction - Line stoppages- Change-overs time- Corrosion of parts

Gains- User experience- User confidence- Marketability- Packaging yield- Process reliability- Productivity (OEE)

Demonstrable and significant benefits Aclar vs HB PVdC

BENEFITS ACLAR VS HB PVDC

Physically stable and biochemically inert, non-ageing, non-yellowing

Fully backward integrated supply chain

Highest moisture barrier per unit thickness

Predictible barrier performance

SUMMARY HONEYWELL ACLAR

Aclar – a most-trusted brand

Enabler for improved user experience

ACKNOWLEDGEMENTS

RON SEIBERT

WALTER GRUPP

GARY SKWAREK

Feel free to contact me using my e-mail: thomas.dries@honeywell.com

ROADMAP

What is Aclar?How & where it is madeKey features

DISCLAIMER

Although Honeywell International Inc. believes that the information contained herein isaccurate and reliable, it is presented without guarantee or responsibility of any kind and doesnot constitute any representation or warranty of Honeywell International Inc., whether expressor implied. A number of factors can affect the package performance, such as packagingdesign, film type, forming equipment and process conditions, and verification process. The listof recommendations for assessing the optimum package design and performance is notintended to be exhaustive, and customer or technical support provided by Honeywell isgratuitous in nature and offered without any warranties or representation. Nothing presentedherein shall relieve the user from the responsibility of carrying out its own assessment,verification, or safety protocols and the user assumes all risks and liability for the use of thisinformation (including, but not limited to, risks relating to results, patent infringement,regulatory compliance and health, safety and environment) related to the use of the productsand suggestions contained herein.

Honeywell PowerPoint template 2019...HB PVdC up to 13.6% thicker than Pentapharm Aclar at comparable...

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