fresenius kabi compounding –canton, ma...what is drug compounding? single components 3-chamber bag...

Fresenius Kabi Compounding – Canton, MA

Fresenius Kabi - Boston Compounding

Andy BassoOperations 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

© 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


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


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

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



South AfricaJohannesburg

ArgentinaBuenos AiresCórdoba

ChileSantiagoConcepción

CanadaCalgaryHamiltonMontréalToronto (x2)Vancouver

BrazilRio de JaneiroSão Paulo

GermanyMunich

NorwayHalden

UKRuncorn

ColombiaBogota

USABoston

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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§ 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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§ Cleaning System– Utilizing “EXACT” volume

– Balance of solutions evaporate

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§ Vapor Hydrogen PeroxideDisinfection

– A “DRY” Process

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§ Waste Stream– 3 drums every Quarter

– Solid, Aqueous, Solvent

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§ Waste Stream Labs– RODI, 2 dish washers

– Limestone tank

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§ Questions?

Thank you

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fresenius kabi compounding –canton, ma...what is drug compounding? single components 3-chamber bag...

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