fresenius kabi compounding –canton, ma...what is drug compounding? single components 3-chamber bag...
TRANSCRIPT
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Fresenius Kabi Compounding – Canton, MA
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Fresenius Kabi - Boston Compounding
Andy BassoOperations Director
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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
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© Copyright Fresenius Kabi
The Fresenius Group
FreseniusHelios
Hospital Operations
FreseniusVamed
Engineering and Services for Health Care Facilities
Fresenius Medical Care
Dialysis Equipment and Services
FreseniusKabi
Infusion Therapies Transfusion TherapiesI.V. Drugs Clinical Nutrition Medical DevicesAseptic Compounding
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)
$17.9b €6.0b €5.8b €1.2bSales 2016
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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
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What is Drug Compounding?
Single components
3-Chamber bag
Mix of variouscomponents
Final compounded product in a bag to feed
the patient in the hospital or at home
Lyophilized Drugs
Liquid Drugs
Liquid Product
Final compounded product in a syringe, bag or device to administer
to the patient in the hospital or at home
Manual or automated preparation
(e.g. reconstitution, dilution, transfer)
IV DRUG COMPOUNDING PN COMPOUNDING
Manual or automated
volume delivery
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IV Drug Compounding Process Example
© Copyright Fresenius Kabi AG
3. Visual inspect & Label
5. Package & Ship
2. Pool finished drug product into pooling bag and either:a) Dose into Diluent bagsb) Dilute then fillc) Direct fill to empty syringe*NaCl or Dextrose
1. Incoming approved Drug
Product
4. QC test and release
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Compounding Evolution
Pharmacy Compounding has come a long way from the past …
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Fresenius Kabi Compounding Experience
§ 18 locations
§ >1,000 employees
§ All compounded therapies
– Oncology
– Anti-infectives
– Anesthesia
– Nutrition
– Other IVs
Overview
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Fresenius Kabi Centers Worldwide
© Copyright Fresenius Kabi AG
© Copyright Fresenius Kabi AG
South AfricaJohannesburg
ArgentinaBuenos AiresCórdoba
ChileSantiagoConcepción
CanadaCalgaryHamiltonMontréalToronto (x2)Vancouver
BrazilRio de JaneiroSão Paulo
GermanyMunich
NorwayHalden
UKRuncorn
ColombiaBogota
USABoston
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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
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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
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Waste Water Reduction
§ Instead of making RODI or WIFI for cleaning§ Instead of making saline or dextrose solutions we
buy them – We buy them
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Waste Water Reduction
§ Cleaning System– Utilizing “EXACT” volume
– Balance of solutions evaporate
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Waste Water Reduction
§ Vapor Hydrogen PeroxideDisinfection
– A “DRY” Process
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Waste Water Reduction
§ Waste Stream– 3 drums every Quarter
– Solid, Aqueous, Solvent
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Waste Water Reduction
§ Waste Stream Labs– RODI, 2 dish washers
– Limestone tank
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§ Questions?
Thank you
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