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Study Protocol – Stage 2 - PQRI

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Parenteral and Ophthalmic Drug Products (PODP) Leachables and Extractables Working Group Issued and Effective September, 2011 Study Protocol Stage 2 Experimental Protocol for Simulation Study of Blow-Fill-Seal (BFS) PODP Container Closure Systems PODP Issued and Effective Leachables and Extractables Working Group September, 2011 Experimental Protocol for Simulation Study , Stage 2 TABLE OF CONTENTS 24 25 26 27 28 29 30 31 32 33 34 35

PODP Issued and Effective Leachables and Extractables Working Group September, 2011 Experimental Protocol for Simulation Study, Stage 2 178 II. Purpose and Scope of Work (Study Protocol Stage 2)

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