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Pharmaceutical Packaging Development Matthew S. Thomas Associate Senior Consultant Engineer, Packaging Development Eli Lilly and Company October 2 nd , 2010 Technical, Quality and Supervisory Reviews Author Review : I confirm that the information in

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Pharmaceutical Packaging Development

Matthew S. Thomas

Associate Senior Consultant Engineer, Packaging Development Eli Lilly and Company October 2nd, 2010

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Technical, Quality and Supervisory Reviews

Author Review: I confirm that the information in this technical presentation is clearly written, scientifically accurate and does not contain any confidential information. ____________________________________________________________________________________________ Matthew S. Thomas, Assoc. Sr. Consultant Engineer, KY227 Date Technical Review: I have reviewed the information in this technical presentation and confirm it is clearly written and scientifically accurate. ____________________________________________________________________________________________ David Dziennik, Consultant Engineer, KY227 Date Quality Review: I have reviewed the information in this technical presentation and confirm it is clearly written and does not contain any confidential information. ____________________________________________________________________________________________ Harold Lowe, Assoc. Consultant QA Representative, KY114 Date Supervisory Review: I have reviewed the information in this technical presentation and confirm the listed author and reviewers are qualified to complete their activities. ____________________________________________________________________________________________ Randy Thackrey, Director, KY227 Date Matthew S. Thomas, Eli Lilly and Company 2

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Pharmaceutical Packaging Development

Packaging Components and Systems
Packaging Regulations
Performance Testing
Product Protection
Patient/User Centered Design

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Packaging Components and Systems

Primary Packaging Component: packaging component that provides product protection and contains materials of construction that come into contact with a pharmaceutical drug product. Critical Secondary Packaging Component: packaging component that provides product protection but does not contain materials of construction that come into contact with a pharmaceutical drug product.

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Packaging Components and Systems

Parenteral Packaging Components for Injection

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Packaging Components and Systems

Parenteral Packaging Systems for Injection

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Packaging Components and Systems

Dry Solid Oral Packaging Components

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Packaging Components and Systems

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Dry Solid Oral Packaging Systems

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Packaging Regulations

Food Contact

– United States Code of Federal Regulations (CFR) – European Directives

Compendia Standards

– United States Pharmacopeia (USP) – European Pharmacopeia (PhEur) – Japanese Pharmacopeia (JP)

Performance Testing

– American Society for Testing and Materials (ASTM) – International Organization for Standardization (ISO) – International Safe Transit Association (ISTA) – United States and European Pharmacopeia

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Stability Testing (Product Protection)

– International Conference on Harmonization (ICH) – World Health Organization (WHO)

Food and Drug Administration (FDA) Guidance

– Container Closure System Suitability

Protection
Compatibility
Safety
Performance

Poison Prevention Packaging Act

Child Resistance and Senior Friendly

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Packaging Regulations

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Performance Testing

Shipping and Distribution (Cold Chain)

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Corrugated Shipping Container Gel Pack Insulation (e.g., expanded polystyrene)

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Performance Testing

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Container Closure Integrity

Sealed Chambers Before Vacuum (1 ATM) Vacuum Applied

Seal Integrity No Seal Integrity

Vacuum / Pressure Decay

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Performance Testing

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Water Vapor Transmission Rate (WVTR)

= Desiccant Temperature and Relative Humidity (RH) Controlled Chambers

Chamber Condition – 25C/60% RH

Inside Package

0% RH

Inside Package

0% RH

WVTR

mg H2 O/day

Chamber Condition – 25C/60% RH

WVTR

mg H2 O/day

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Performance Testing

Water Vapor Transmission Rate (WVTR)

Diffusion Sorption Desorption

Outside Package (high RH) Inside Package (low RH) WVTR

H2 O H2 O

Plastic Wall Cross Section

PET Bottles HDPE Bottles Typical Blister Laminate PVC PVDV

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ICH and WHO Stability Conditions

Zone I and II Countries (Temperate & Subtropical/Mediterranean)

– Real time storage at 25C/60%RH

Zone III and IV Countries (Hot/Dry & Hot/Humid)

– Real time storage at 30C/65%RH or 30C/75%RH

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Product Protection (stability testing)

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Patient/User Centered Design

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Patient/User Centered Design

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Patient/User Centered Design

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Patient/User Centered Design

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