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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview Company Confidential Copyright © 2000 Eli Lilly and Company Agenda Parenteral Overview Supply Chain Simulation Divide into 4 Groups for Equipment Demos Aseptic Gowning Manufacturing Filling Freeze Dry
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 2 of 26 Course # MF30629-002 BET ID: 253589 Parenteral Introducing a drug into the body some way other than through the digestive system. Definition
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 3 of 14 Course # MF30629-002 BET ID: 253589 OralBenefitInjectable Less expensive Administrable to nonresponsive patients Patient convenience and comfort Administrable directly to site of action Retrievable, if necessary Better absorption Description Rapid onset of action
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 4 of 14 Course # MF30629-002 BET ID: 253589 IndicationProduct AntipsychoticZyprexa DiabetesHumulin, Humalog Growth HormoneHumatrope CancerGemzar, Alimta Parenteral Products
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 5 of 14 Course # MF30629-002 BET ID: 253589 Fegersheim, France Giessen, Germany Sesto, Italy Indianapolis, USA (B103, B105, B107, DDAO) Parenteral Sites
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 6 of 14 Course # MF30629-002 BET ID: 253589 BulkProcurementForm/FillFinishAffiliateDistributionWholesalerRetailConsumer Parenteral Manufacturing Supply Chain & Production Planning
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 7 of 14 Course # MF30629-002 BET ID: 253589 Air Quality Facilities are divided into 4 grades of air quality: 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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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 8 of 14 Course # 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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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 9 of 14 Course # MF30629-002 BET ID: 253589 Movement disturbs the airflow and stirs up particles. Facility
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 10 of 14 Course # MF30629-002 BET ID: 253589 Sterile Filtration Non-Sterile Sterile
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 11 of 14 Course # MF30629-002 BET ID: 253589 Filling Line – Traditional Method – Vials Filling
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview 12 of 14 Course # MF30629-002 BET ID: 253589 Freeze Drying
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview B105 DC Process Flow Company Confidential Copyright © 2000 Eli Lilly and Company August 2010 START END 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 Sterilization From Component Warehouse Incoming Vials Vial Wash Vial Depyrogenation Vial Filling, Stoppering
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... Clear and simple Parenteral Overviews Parenteral Manufacturing Overview INTRODUCTION OF PARENTERAL REPRESENTATIVES
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