clear and simple parenteral overviews parenteral manufacturing overview company confidential...
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. . . Clear and simple
Parenteral Overviews
Parenteral Manufacturing OverviewCompany ConfidentialCopyright © 2000 Eli Lilly and Company
Agenda
• Parenteral Overview
• Supply Chain Simulation
•Divide into 4 Groups for Equipment Demos
• Aseptic Gowning
• Manufacturing
• Filling
• Freeze Dry
. . . Clear and simple
Parenteral Overviews
Parenteral Manufacturing Overview2 of 26Course # MF30629-002 BET ID: 253589
Parenteral
Introducing a drug into the body some way other than through the digestive system.
Definition
. . . Clear and simple
Parenteral Overviews
Parenteral Manufacturing Overview 3 of 14Course # MF30629-002 BET ID: 253589
OralBenefit Injectable
Less expensive
Administrable to nonresponsive patientsPatient convenience and comfort
Administrable directly to site of actionRetrievable, if necessary
Better absorption
Description
Rapid onset of action
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Parenteral Overviews
Parenteral Manufacturing Overview 4 of 14Course # MF30629-002 BET ID: 253589
Indication Product
Antipsychotic Zyprexa
Diabetes Humulin, Humalog
Growth Hormone Humatrope
Cancer Gemzar, Alimta
Parenteral Products
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Parenteral Overviews
Parenteral Manufacturing Overview 5 of 14Course # MF30629-002 BET ID: 253589
Fegersheim, France
Giessen, Germany
Sesto, Italy
Indianapolis, USA (B103, B105, B107,
DDAO)
Parenteral Sites
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Parenteral Overviews
Parenteral Manufacturing Overview 6 of 14Course # MF30629-002 BET ID: 253589
BulkBulkProcurementProcurement Form/FillForm/Fill FinishFinish AffiliateAffiliateDistributionDistribution WholesalerWholesaler RetailRetail ConsumerConsumer
RETAIL
Parenteral Manufacturing Supply Chain & Production Planning
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Parenteral Overviews
Parenteral Manufacturing Overview 7 of 14Course # MF30629-002 BET ID: 253589
Air Quality
Facilities are dividedinto 4 grades of airquality:
• Grade A – Exposed Product• Grade B – Adjacent to
Product (Operators fully gowned)
• Grade C – Non- Sterile Production area (Formulation)
• Grade D – General Corridors
A (Exposed Product)
B
C
D
Facility
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Parenteral Overviews
Parenteral Manufacturing Overview 8 of 14Course # MF30629-002 BET ID: 253589
Garments
Keep the operator from spreading any unwanted contaminants to the product and environment.
People Practices
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Parenteral Overviews
Parenteral Manufacturing Overview 9 of 14Course # MF30629-002 BET ID: 253589
Movement disturbs the airflow and stirs up particles.
Facility
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Parenteral Overviews
Parenteral Manufacturing Overview 10 of 14Course # MF30629-002 BET ID: 253589
Sterile Filtration
Non-Sterile Sterile
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Parenteral Overviews
Parenteral Manufacturing Overview 11 of 14Course # MF30629-002 BET ID: 253589
Filling Line – Traditional Method – Vials
Filling
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Parenteral Overviews
Parenteral Manufacturing Overview 12 of 14Course # MF30629-002 BET ID: 253589
Freeze Drying
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Parenteral Overviews
Parenteral Manufacturing Overview
B105 DC Process Flow
Company ConfidentialCopyright © 2000 Eli Lilly and Company
August 2010
STARTEND
Performed within Grade “A” areas
To Packaging
Vial Trayoff
Vial Inspection
Vial Capping
Tank CIP
Tank SIP
Formulation/
Filtration
Incoming Raw
Materials
From Dispensing
Incoming
Stoppers
Stopper Sterilizatio
n
From Component Warehouse
Incoming Vials
Vial Wash
Vial Depyrogenation
Vial Filling, Stoppering
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Parenteral Overviews
Parenteral Manufacturing Overview
INTRODUCTION OF PARENTERAL REPRESENTATIVES