Developing Temperature Controlled Environmental Test Standards

Transcription

1 Developing Temperature Controlled Environmental Test Standards 1 Ed Church Executive Director 2 nd Annual Biotech Supply Chain Academy

2 2 History ISTA Pioneered Packaging Performance Testing Procedures back in 1948 Now a Global Leader, Innovator and Creator of Preshipment Packaged-Product Testing Standards 775 Member Companies

3 3 ISTA in 20 Seconds We set the standard of performance that a package must meet to protect the quality of the product from the hazards found in storage, handling and transportation throughout the supply chain.

4 4 Regulatory expectations have changed now that Companies are governed by CDER Center for Biologics Evaluation and Research CBER Science Based Why you do it Risk Averse Status Quo Scientific Exploration Center for Drugs Evaluation and Research CDER GMP Based How you do it Risk Focused Continuous Improvement Quality by Design

5 FDA introduced new guidance on GMPs for the 21 st Century, including Quality by Design Monitor Validate Define Characterize Design Quality by design means designing and developing manufacturing processes during the product development stage to consistently ensure a predefined quality at the end of the manufacturing process - FDA Draft Guidance, Sept

6 6 Current State of Packaging Qualification User Requirements Company Hot and Cold Profiles Company Drop Sequence Company Distribution Lane Protocols for Thermal Design Protocols for Thermal Qualification Protocols for Physical Qualification Verification Protocol Design Data Qualification Data Qualification Data Verification Data = Cold Chain Packaging Configuration Report for Thermal Design Report for Thermal Qualification Report for Physical Qualification Verification Report

7 7 ISTA Hot and Cold Profile Protocols Hot Campaign Hot Profile Cold Campaign Cold Profile ISTA Thermal Profiles 100% Complete 100% Complete 50% Complete 100% Complete 95% Complete 75% Complete Projected Completion 4Q 2009

8 Temperature ( C) 8 Heat and Cold Profile Time (Hours) Heat Prof ile Temperat ure Cold Prof ile Temperat ure

9 Acceleration (g s) ISTA Shock Profile 0 Time (ms) 9

10 Drop Height Profile 10

11 Over the Road Random Vibration 11

12 Vibration Profile Steel-Spring Truck Delivery Van TOFC Rail - India 12

13 Air Pressure - Data Analysis 13

14 14 Air Pressure - Data Analysis Plane Pressurized to 8,000 ft.

15 Pressure (in HgVAC) Altitude (ft) Amgen Global Global Pressure Pressure Profile Profile Hours 0.00 Pressure (in HgVAC) Altitude (ft) 15

16 ISTA Standards 16

17 17 ISTA Test Procedures Are science based with data to support their claim. Test profiles replicate known and anticipated environmental conditions in the distribution network. Give you a degree of confidence that the end result meets all user requirements and regulations requirements.

18 18 New Cold Chain Standards ista Standards ista Hot and Cold Profiles ista Shock Profiles ista Qualification Process ista Cold Chain Qualification Manual ista Cold Chain Certified Test Labs ista Vibration Profiles ista Trained Personnel ista Pressure Profiles

19 ista Qualification Manual

20 20 ISTA Qualification Manual - 20 Write the protocols using guidance from MAN-0020 APPX-00XX provides an example of how to write a protocol following MAN-0020 Protocol will contain: Title Introduction Purpose Scope Equipment & Materials Responsibilities Test Procedures Data Analysis Techniques Acceptance Criteria

21 21 ISTA Qualification Manual - 20 Assemble Data Package using format in MAN-0020 APPX-00XXXX provides an example of how to assemble a data package How data should be organized How to format data How to analyze data APPX-00XXX provides an example of the Table of Contents for the data package

22 ISTA Qualification Manual - 20 Write the report using guidance from MAN-0000XX APPX-00XXXX provides an example of how to write a report following MAN-0000XX Report will contain: Title Summary Introduction Equipment & Materials Exceptional Conditions Results Discussion Conclusion 95% complete 22

23 23 ISTA Test Profiles ISTA Certified Lab

24 24 ISTA Trained Personnel Certified Packaging Laboratory Professional

25 Vendor Qualifying their Cold Chain Packaging to Industry Standards 25 Packaging Suppliers

26 ISTA Believes Biopharma companies will have to lower their packaging costs in the future Biopharma companies have the following in common; Primary and secondary package vendor pool Compendia defined storage requirements Wholesale / Retail Distribution lanes The need to reduce cycle times The publishing of best practices that address common concerns above will become industry standards 26

27 Questions 27