Fresenius Kabi Compounding Canton, MA

Fresenius Kabi Compounding Canton, MA

Fresenius Kabi - Boston Compounding Andy Basso Operations Director

Agenda Existential question: Why am I here? Who is Fresenius-Kabi? What does our Canton Facility do? Why we are building a Compounding Facility? How do we reduce waste water usage? Questions/Wrap-up Copyright Fresenius Kabi AG

The Fresenius Group Fresenius Medical Care Fresenius Kabi Fresenius Helios Fresenius Vamed Dialysis Equipment and Services Infusion Therapies Transfusion Therapies I.V. Drugs Clinical Nutrition Medical Devices Aseptic Compounding Sales 2016 Hospital Operations Engineering and Services for Health Care Facilities $17.9b 6.0b 5.8b 1.2b Fresenius SE is a global health care group based in Frankfurt Germany, with annual sales of 29b and more than 260,000 employees (2017) Recently acquired 4.5b Akorn and Merck Biologics (Germany) Copyright Fresenius Kabi 4

What is Compounding? Allows physicians to prescribe a very specific medication for a patient's individual needs Allergy Dosage form Established tradition 80% of prescriptions were compounded until the 1920 s Decreased with modern pharmaceutical manufacturing Still done by Nurses, Doctors, Pharmacists Medication errors Less efficient / expensive Why Commercially Compound? Provides convenience for high volume product With increase of regulations, smaller facilities cannot meet the requirements Copyright Fresenius Kabi AG

What is Drug Compounding? IV DRUG COMPOUNDING PN COMPOUNDING Lyophilized Drugs Liquid Drugs Single components 3-Chamber bag Liquid Product Manual or automated preparation (e.g. reconstitution, dilution, transfer) Mix of various components Manual or automated volume delivery Final compounded product in a syringe, bag or device to administer to the patient in the hospital or at home Final compounded product in a bag to feed the patient in the hospital or at home 6

IV Drug Compounding Process Example 1. Incoming approved Drug Product 2. Pool finished drug product into pooling bag and either: a) Dose into Diluent bags b) Dilute then fill c) Direct fill to empty syringe *NaCl or Dextrose 3. Visual inspect & Label 5. Package & Ship 4. QC test and release Copyright Fresenius Kabi AG

Compounding Evolution Pharmacy Compounding has come a long way from the past 8

Fresenius Kabi Compounding Experience Fresenius Kabi Centers Worldwide Overview Copyright Fresenius Kabi AG Canada Calgary Hamilton Montréal Toronto (x2) Vancouver Colombia Bogota Chile Santiago Concepción USA Boston UK Runcorn Argentina Buenos Aires Córdoba Norway Halden Brazil Rio de Janeiro São Paulo Germany Munich South Africa Johannesburg 18 locations >1,000 employees All compounded therapies Oncology Anti-infectives Anesthesia Nutrition Other IVs Copyright Fresenius Kabi AG 9

Need for Regulation New England Compounding Center incident 2012 Previous regulation Contaminated methylprednisolone Steroid injections > 700 cases of fungal meningitis and > 76 fatalities New Drug Safety Act 2013 created new compounder category Outsourcing Facilities in Section 503B FD&C Act Require drug manufacturing GMP quality standards FDA licensed and inspected 10

Waste Water Reduction Handwashing Stations Removes 99.98% of Dangerous Pathogens Full wash and rinse all in one 12 Second Standardized and Controlled Handwash Fast ROI by reducing labor time, water, and waste by 75% Guaranteed High Quality Handwash Every Time for Every User 11

Waste Water Reduction Instead of making RODI or WIFI for cleaning Instead of making saline or dextrose solutions we buy them We buy them 12

Waste Water Reduction Cleaning System Utilizing EXACT volume Balance of solutions evaporate 13

Waste Water Reduction Vapor Hydrogen Peroxide Disinfection A DRY Process 14

Waste Water Reduction Waste Stream 3 drums every Quarter Solid, Aqueous, Solvent 15

Waste Water Reduction Waste Stream Labs RODI, 2 dish washers Limestone tank 16

Questions? Thank you 17