Agenda
Parenteral Overviews
. . . Clear and simple
• Parenteral Overview
• Supply Chain Simulation
• Divide into 4 Groups for
Equipment Demos
• Aseptic Gowning
• Manufacturing
• Filling
• Freeze Dry
Parenteral Manufacturing Overview
Company Confidential
Copyright © 2000 Eli Lilly and Company
Parenteral Overviews
Definition
. . . Clear and simple
Parenteral
Introducing a drug into
the body some way
other than through the
digestive system.
Parenteral Manufacturing Overview
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Course # MF30629-002 BET ID: 253589
Parenteral Overviews
Description
. . . Clear and simple
Benefit
Oral
Injectable
Rapid onset of action
Less expensive
Administrable to nonresponsive patients
Patient convenience and comfort
Administrable directly to site of action
Retrievable, if necessary
Better absorption
Parenteral Manufacturing Overview
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Parenteral Overviews
Parenteral Products
. . . Clear and simple
Indication
Product
Antipsychotic
Zyprexa
Diabetes
Humulin, Humalog
Growth Hormone
Humatrope
Cancer
Gemzar, Alimta
Parenteral Manufacturing Overview
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Parenteral Overviews
Parenteral Sites
Indianapolis, USA
(B103, B105, B107,
DDAO)
. . . Clear and simple
Fegersheim,
France
Giessen,
Germany
Sesto, Italy
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Parenteral Manufacturing Supply Chain &
Production Planning
Parenteral Overviews
. . . Clear and simple
RETAIL
Procurement
Bulk
Form/Fill Finish
Parenteral Manufacturing Overview
Distribution
Affiliate
Wholesaler
Retail
Consumer
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Parenteral Overviews
Facility
. . . Clear and simple
Air Quality
Facilities are divided
into 4 grades of air
quality:
A
(Exposed
Product)
B
C
D
Parenteral Manufacturing Overview
• Grade A – Exposed Product
• Grade B – Adjacent to
Product (Operators fully
gowned)
• Grade C – Non- Sterile
Production area
(Formulation)
• Grade D – General
Corridors
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Parenteral Overviews
People Practices
. . . Clear and simple
Garments
Keep the operator from spreading
any unwanted contaminants to the
product and environment.
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Course # MF30629-002 BET ID: 253589
Parenteral Overviews
Facility
. . . Clear and simple
Movement disturbs the
airflow and stirs up
particles.
Parenteral Manufacturing Overview
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Parenteral Overviews
Sterile Filtration
Non-Sterile
Parenteral Manufacturing Overview
. . . Clear and simple
Sterile
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Parenteral Overviews
Filling
. . . Clear and simple
Filling Line – Traditional Method – Vials
Parenteral Manufacturing Overview
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Parenteral Overviews
Freeze Drying
Parenteral Manufacturing Overview
. . . Clear and simple
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Parenteral Overviews
B105 DC Process Flow
. . . Clear and simple
Performed within
Grade “A” areas
Tank CIP
Tank SIP
Vial Filling,
Stoppering
Vial
Capping
Formulation/
Filtration
Stopper
Sterilization
Vial
Depyrogenation
Vial
Wash
Incoming
Raw
Materials
Incoming
Stoppers
Incoming
Vials
Vial
Inspection
Vial
Trayoff
END
START
From
Dispensing
Parenteral Manufacturing Overview
From Component Warehouse
To
Packaging
Company Confidential August 2010
Copyright © 2000 Eli Lilly and Company
Parenteral Overviews
. . . Clear and simple
INTRODUCTION OF PARENTERAL
REPRESENTATIVES
Parenteral Manufacturing Overview