Note This corporate presentation can be used by all MSD Animal - - PowerPoint PPT Presentation

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Note This corporate presentation can be used by all MSD Animal - - PowerPoint PPT Presentation

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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,

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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

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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
  • 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 9

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

B

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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

*All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 11

C

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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 & AFTER photos were adequately protected from potential workplace exposures 12

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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)
  • 99% reduction in Airborne Concentration
  • Ergonomic improvement-bag support installed

*All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 13

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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

*All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 14

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)

*All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 15

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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
  • ccurs 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 16

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Charging of OEB 3 Compounds

(OEL = 20 mcg/m3)

AFTER

  • 55% reduction in Airborne Concentration

BEFORE

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

*All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 17

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Charging of OEB 3 Compounds

(OEL = 10 mcg/m3)

AFTER

  • Flexible barrier made on site to separate
  • perator from API charge/dissolution and roller

table added to aid in manual handling.

  • 64% reduction in Airborne Concentration

BEFORE

  • Manual charging 127 kg API with inefficient LEV

*All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 18

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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 19

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Continuous Improvements – OEB2 Formulation

Raw Material Dispensing Discharging Granulator Charging Fluid Bed Dryer

*All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 20

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Continuous Improvements – Substitution of Formaldehyde Fumigation

Sanosil Chlordisys

*All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 21

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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

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