merck consumer preferred template version april 2011

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Note

• This corporate presentation can be used by all MSD Animal Health

employees, and can be used with customers.

• This presentation aims to provide the basic company facts

• The slides of the PowerPoint presentation can be translated,

rearranged, or a selection can be made, by using the standard tools

within PowerPoint

• The slides can also be copied into one of the other available MSD

Animal Health PowerPoint templates (see in PowerPoint: file > new

> …)

Please delete this slide prior to use.

Merck Animal Health

Our Journey of Continuous Improvement

May 2016

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Key Company Facts

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Merck Animal Health Today

• Pharmaceuticals and vaccines

• Species categories: ruminants, poultry, swine,

aquatic, and companion animals

• Broad product range: vaccines, anti-parasitics, anti-

infectives, reproduction management,

pharmaceutical specialties, and innovative animal

health programs, such as pet recovery

• Offices in more than 50 countries, marketing

activities in more than 140 countries

• Operating dedicated animal health manufacturing

and research & development sites around the world

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Leading in Animal Health Products and Services

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Animal Health Specifics

RUMINANTS

• Cattle (dairy & beef),

sheep and goats

• Efficient production

and control of

disease

POULTRY

• Broilers, breeders,

and layers

• Health is mainly

economically driven

SWINE

• Sows and

finishers

• Growth in

respiratory

vaccines segment

COMPANION ANIMAL

• Dogs, cats,

and horses

• Fastest growing

segment over the

past 15 years

AQUATIC

• Emerging

industry, fast

growing

• Diseases vary

with water

temperature

• A leader in

– Cattle segment

– Poultry segment

– Swine segment

– Aquatic segment

– Sheep segment

• Top 4 of Companion

Animal segment

Merck Animal Health

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Animal Health Industry Specifics

• Interconnectivity of animal and

human health

• Research & development process

and lead time

– Complexity and planning similar

to human pharmaceutical

business

• Heavily regulated/high compliance

requirements, including food safety

• Partnerships with customers,

providing effective disease

prevention and treatment strategies

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IH Hazards vs. Risks

• Higher Concentration of Highly Active Pharmaceutical Compounds in Final Products

• (77% OEB 3)

• (70% OEB 5)

• (50% OEB 2)

• Powder/granule form of some Final Products

• (50% OEB 2)

• (4.8% OEB 4)

• High number of potent compounds used

• Site A: 5 OEB 5, 8 OEB 4

• Site B: 4 OEB 5, 3 OEB 4

• Site C: 2 OEB 5, 3 OEB 4

• Site D: 2 OEB 5, 2 OEB 4

• Some of the lowest OEL/Highly Actives (OEB 5):

• 0.03 ug/m3 STEL (2 sites)

• 0.01 ug/m3 TWA (1 site)

• 0.01 ug/m3 TWA (1 site)

*OEB = Occupational Exposure Band

*OEL = Occupational Exposure Limit

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Our Journey

1. Animal Health Business

– EHS Programs evolving

2. Prioritize Evaluation – 2 Phases

– Potent Compound Use, Product Presentations, % API

– Phase 1 – Qualitative Assessments

– Phase 2 – Quantitative Assessments

3. RPE/PPE Upgrades & Zoning (Phase 1 & Phase 2, if necessary)

4. Develop prioritized IH target plans (2013 – 2019)

– Share Surrogate data where applicable

5. Evaluate Feasible Engineering Controls

6. Resources obtained: Internal & External containment expertise, Internal &

External IH for containment verification

7. Funding: Central funding for high priority tasks

Sustainability: Build Knowledge within the business through IH

Community of Practice, Best Practice Sharing, HANDS ON Regional IH Support

The Key to Our Journey = Continuous Improvement

1st immediately ensure employee protection & 2nd evaluate/implement feasible

engineering controls

*RPE=Respiratory Protection

*PPE=Personal Protective Equipment 7

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Where Have we Been & Where are we Going?

• 2013 2019

Total Target Actions: 678

Completed to Date: 378

• 23 Prioritized IH Plans

o Contain both simple upgrades & more complicated

engineering projects

• 9 separate consultant projects in 2016 alone

All employees depicted in the following BEFORE &

AFTER photos were adequately protected from

potential workplace exposures.

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• 92% reduction in airborne

concentration (based on 95th%ile

point estimate)

• 98% reduction in surface

contamination

• Faster room cleaning – operation

confined to VBE (estimated saving of

time / year: 26 hours)

In Process Control Testing of OEB 5 compounds (OEL 0.2 ug/m3, 0.05 ug/m3)

*All employees depicted in the BEFORE & AFTER

photos were adequately protected from potential

workplace exposures

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BEFORE

IPC Equipment not in dedicated area

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Dispensing of OEB 5 compounds (OEL 0.2 ug/m3, 0.05 ug/m3)

BEFORE

• Open WIBO for IBC Dispensing & Charging

AFTER

• 1st flexible containment retrofit (1st modification, Solo

Containment)

• Plastic curtain mounted on WIBO with plastic sleeves.

• 70% reduction in Airborne Concentration

*All employees depicted in the BEFORE &

AFTER photos were adequately protected

from potential workplace exposures 10

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Dispensing of OEB 5 compounds (cont.) (OEL 0.2 ug/m3, 0.05 ug/m3)

• 2nd flexible containment retrofit (2nd modification, WEISS GWE and Lugaia)

• Frame mounted on WIBO (welded gloves), capable of being opened via a push button.

• Frame fitted so that drums may be placed into WIBO without opening containment.

• A flexible sleeve will be installed for transfer of API into IBC to further reduce exposures

• 71% airborne concentration reduction from 1st modification

• 91% reduction from open WIBO




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Dispensing of OEB 5 compounds (OEL 0.01 ug/m3)

BEFORE

• Weighing 200g OEB5 & 400g OEB4

preparation of concentrate solution

& addition of concentrate to

compounding

• Ventilated enclosure

AFTER

• Dedicated suite with airlock

• Isolator (adj. height, bag-out port,

remote printing)

• 99.99% reduction in Airborne

Concentration

• Reduce PPE use (~$91K for 15

years). Double coveralls no longer

required.

• Cleaning process optimized.

• Process better accepted by

personnel, because more reliable

due to higher personnel safety.

• Mettler balance integrated into

isolator, with printout externally-

greatly simplifies process. *All employees depicted in the BEFORE &



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Charging of OEB 5 / OEB 4 compounds (OEL 0.1 ug/m3 / 5 ug/m3)

BEFORE

• Manual charging 600 g OEB5 & 1.125 kg OEB4

(no controls)

AFTER

• ILC Dover EZPak, vessel manway adapted

• Bag rinsed before clamp removed (only for OEB5)


• Ergonomic improvement-bag support installed




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Charging of OEB 4 compound (OEL 1 ug/m3)

BEFORE

AFTER -57% reduction (charging) Water

consumption

savings with

Clean In Place

(CIP)

implementation




API

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Dispensing & Charging of Potent Compounds

In Hormone Facility BEFORE

• Ventilated Balance Enclosure Dispensing & Open Powder Charging OEB 4/5 (1.6 – 360 g)

AFTER

• Ventilated Containment Dispensing, Creation of Slurry, & pumping of slurry into process vessel

• 90% reduction in airborne Potent APIs (OEB4/5)




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Weighing & Dispensing of OEB 3 compounds (OEL = 30 mcg/m3)

BEFORE AFTER – Work Practice & Airflow Upgrades

• Table re-orientation directly in front of air grille, all work

occurs in “safe zone”

• HEPA vacuum and cleaning after spillage and/or

dispensing completed.

98% reduction in Airborne Concentration-RPE redundant

AFTER-work practice improvements

• Increase external blower flowrate

• Establish work zone

• Work perpendicular to air grilles at back of

Downflow Booth

• Establish Potent compound zones

• Training: contaminated items in Red zone

• HEPA Vacuum: Clean as you go

• Replace brush piece

*All employees depicted in the

BEFORE & AFTER photos were

adequately protected from potential

workplace exposures

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Charging of OEB 3 Compounds (OEL = 20 mcg/m3)

AFTER


BEFORE

• Manual charging 1000 kg API (40 x 25 kg bags)




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Charging of OEB 3 Compounds (OEL = 10 mcg/m3)

AFTER

• Flexible barrier made on site to separate

operator from API charge/dissolution and roller

table added to aid in manual handling.


BEFORE

• Manual charging 127 kg API with inefficient LEV




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Dispensing of OEB 3 Compounds

AFTER

• 98.5% reduction in Airborne Concentration

BEFORE

Manual dispensing in DFB

• PPE + work practice upgrades

*All employees depicted in

the BEFORE & AFTER

photos were adequately

protected from potential

workplace exposures

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Continuous Improvements – OEB2 Formulation

Raw Material Dispensing

Discharging Granulator

Charging Fluid Bed Dryer




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Continuous Improvements –

Substitution of Formaldehyde Fumigation

Sanosil

Chlordisys




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Key Lessons

1. IH Improvements Production Benefits

• Decrease airborne concentrations

• Decreased cost of RPE/PPE

• Decrease production cost of water consumption, people/hours

• Increased efficiency

2. Operator training crucial / Reiterate proper work practices multiple times

3. Hands-On support is crucial

4. Continuous training of EHS professionals at sites also key for success

5. Effort must be placed on continuous improvement to maintain

• New product / process evaluations – MOC

• Re-evaluation of engineering controls/data

6. Challenges continue…

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Acknowledgements

• Martin Maher

• Terry Lane

• Ed Rauch

• Rich Hampson

• Fred Usbeck - Merck IH Laboratory

• Animal Health IH Coordinators

• Animal Health Site Managers

• Global Safety & Environment (GSE) Leadership Team

• Business Partners

• General IH

• Ed Holmes (Pharma Confinement Strategies)

• Maharshi Mehta (ISS)

• Containment

• Hari Floura (Floura, LLC)

• Justin Mason (SafeBridge)

• Gary Johnson (Workplace Exposure Solutions)

• PPE

• Tim Zeh, David Smith (Fisher Scientific)

• Scott Shin, Eric Rodgers (3M)

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Questions?

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Updated Brand Video

“The Science of Healthier AnimalsTM”

Merck Animal Health

THERE’S

ONLY ONE

THING THAT

DRIVES US

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merck consumer preferred template version april 2011

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