Pharmaceutical Packaging Development Matthew S. Thomas Associate - PowerPoint PPT Presentation

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 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

Pharmaceutical Packaging Development • Packaging Components and Systems • Packaging Regulations • Performance Testing • Product Protection • Patient/User Centered Design Matthew S. Thomas, Eli Lilly and Company 3

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. Matthew S. Thomas, Eli Lilly and Company 4

Packaging Components and Systems Parenteral Packaging Components for Injection Matthew S. Thomas, Eli Lilly and Company 5

Packaging Components and Systems Parenteral Packaging Systems for Injection Matthew S. Thomas, Eli Lilly and Company 6

Packaging Components and Systems Dry Solid Oral Packaging Components Matthew S. Thomas, Eli Lilly and Company 7

Packaging Components and Systems Dry Solid Oral Packaging Systems Matthew S. Thomas, Eli Lilly and Company 8

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 Matthew S. Thomas, Eli Lilly and Company 9

Packaging Regulations 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 Matthew S. Thomas, Eli Lilly and Company 10

Performance Testing Shipping and Distribution (Cold Chain) Insulation (e.g., expanded polystyrene) Gel Pack Corrugated Shipping Container Matthew S. Thomas, Eli Lilly and Company 11

Performance Testing Container Closure Integrity Vacuum / Pressure Decay Before Vacuum (1 ATM) Vacuum Applied Seal Integrity No Seal Integrity Sealed Chambers Matthew S. Thomas, Eli Lilly and Company 12

Performance Testing Water Vapor Transmission Rate (WVTR) Temperature and Relative Humidity (RH) Controlled Chambers Chamber Condition – 25C/60% RH Chamber Condition – 25C/60% RH WVTR mg H 2 O/day Inside Package WVTR 0% RH mg H 2 O/day Inside Package 0% RH = Desiccant Matthew S. Thomas, Eli Lilly and Company 13

Performance Testing Water Vapor Transmission Rate (WVTR) Plastic Wall Cross Section HDPE Outside Package Inside Package Bottles (high RH) (low RH) Sorption Diffusion Desorption PET H 2 O H 2 O Bottles PVC Typical Blister Laminate WVTR PVDV Matthew S. Thomas, Eli Lilly and Company 14

Product Protection (stability testing) 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 Matthew S. Thomas, Eli Lilly and Company 15

Patient/User Centered Design Matthew S. Thomas, Eli Lilly and Company 16

Patient/User Centered Design Matthew S. Thomas, Eli Lilly and Company 17

Patient/User Centered Design Matthew S. Thomas, Eli Lilly and Company 18

Patient/User Centered Design Matthew S. Thomas, Eli Lilly and Company 19

Patient/User Centered Design Matthew S. Thomas, Eli Lilly and Company 20