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 Merck Animal Health • The slides can also be copied into one of the other available MSD Animal Health PowerPoint templates (see in PowerPoint: file > new Our Journey of Continuous Improvement > …) May 2016 Please delete this slide prior to use. 1
Key Company Facts 2 1
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 3 2
Leading in Animal Health Products and Services 4 3
Animal Health Specifics POULTRY • Broilers, breeders, and layers • Health is mainly economically driven RUMINANTS SWINE Merck • Cattle (dairy & beef), • Sows and sheep and goats Animal Health finishers • Efficient production • Growth in and control of respiratory • A leader in disease vaccines segment – Cattle segment COMPANION AQUATIC – Poultry segment ANIMAL • Emerging – Swine segment • Dogs, cats, industry, fast – Aquatic segment and horses growing • Fastest growing – Sheep segment • Diseases vary segment over the with water past 15 years • Top 4 of Companion temperature Animal segment 5 4
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 6 5
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 • *OEB = Occupational Exposure Band Site D: 2 OEB 5, 2 OEB 4 *OEL = Occupational Exposure Limit • 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) 7 6
Our Journey The Key to Our Journey = Continuous Improvement 1 st immediately ensure employee protection & 2 nd evaluate/implement feasible engineering controls 1. Animal Health Business – EHS Programs evolving Prioritize Evaluation – 2 Phases 2. – 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) Develop prioritized IH target plans (2013 – 2019) 4. – 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 *RPE=Respiratory Protection 8 *PPE=Personal Protective Equipment 7
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. 9 8
In Process Control Testing of OEB 5 compounds (OEL 0.2 ug/m3, 0.05 ug/m3) BEFORE IPC Equipment not in dedicated area • 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) *All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 10 9
Dispensing of OEB 5 compounds (OEL 0.2 ug/m3, 0.05 ug/m3) BEFORE AFTER • • Open WIBO for IBC Dispensing & Charging 1st flexible containment retrofit (1st modification, Solo Containment) • Plastic curtain mounted on WIBO with plastic sleeves. • 70% reduction in Airborne Concentration B *All employees depicted in the BEFORE & AFTER photos were adequately protected 11 from potential workplace exposures 10
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 1 st modification • 91% reduction from open WIBO *All employees depicted in the BEFORE & C 12 AFTER photos were adequately protected 11 from potential workplace exposures
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 & 13 AFTER photos were adequately protected 12 from potential workplace exposures
Charging of OEB 5 / OEB 4 compounds (OEL 0.1 ug/m3 / 5 ug/m3) AFTER BEFORE • • ILC Dover EZPak, vessel manway adapted Manual charging 600 g OEB5 & 1.125 kg OEB4 • Bag rinsed before clamp removed (only for OEB5) (no controls) • 99% reduction in Airborne Concentration Ergonomic improvement-bag support installe d • *All employees depicted in the BEFORE & 14 AFTER photos were adequately protected 13 from potential workplace exposures
Charging of OEB 4 compound (OEL 1 ug/m3) BEFORE API AFTER -57% reduction (charging) Water consumption savings with Clean In Place (CIP) implementation *All employees depicted in the BEFORE & 15 AFTER photos were adequately protected 14 from potential workplace exposures
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 & 16 AFTER photos were adequately protected 15 from potential workplace exposures
Weighing & Dispensing of OEB 3 compounds (OEL = 30 mcg/m3) AFTER – Work Practice & Airflow Upgrades BEFORE • 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 • *All employees depicted in the Replace brush piece BEFORE & AFTER photos were adequately protected from potential workplace exposures 17 16
Charging of OEB 3 Compounds (OEL = 20 mcg/m3) BEFORE • Manual charging 1000 kg API (40 x 25 kg bags) AFTER • 55% reduction in Airborne Concentration *All employees depicted in the BEFORE & 18 AFTER photos were adequately protected 17 from potential workplace exposures
Charging of OEB 3 Compounds (OEL = 10 mcg/m3) BEFORE • Manual charging 127 kg API with inefficient LEV AFTER • Flexible barrier made on site to separate operator from API charge/dissolution and roller table added to aid in manual handling. • 64% reduction in Airborne Concentration *All employees depicted in the BEFORE & AFTER photos were adequately protected 19 from potential workplace exposures 18
Dispensing of OEB 3 Compounds BEFORE Manual dispensing in DFB AFTER • 98.5% reduction in Airborne Concentration • PPE + work practice upgrades *All employees depicted in the BEFORE & AFTER photos were adequately protected from potential workplace exposures 20 19
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