Comment from Amarjit Luniwal
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Summary: The commenter, likely a representative of a pharmaceutical or medical device company (implied by the technical focus on "sponsors" and "combination products"), argues that the draft guidance lacks a clear definition for "semi-permeable" packaging. They recommend establishing quantitative thresholds and clarifying the scope of the term to ensure consistency in extractables and leachables testing.
“Semi-Permeable” Is Undefined
Sections referenced: 3.1, 3.5, Appendix 1 (Table A.1.2)
The draft requires that “semi-permeable” packaging trigger evaluation of indirect contact sources (secondary packaging, inks, adhesives) — but never defines “semi-permeable.” No permeability threshold, no material list, no clarity on whether it applies to the material, the container system, or the system plus secondary packaging.
Common polymers like polypropylene (oral syringes, prefilled syringes, combination product housings) have measurable but low permeability. Depending on interpretation, nearly any polymer could qualify, or none would except high-permeability films. This creates inconsistent outcomes across sponsors and reviewers, particularly for combination products newly in scope.
It also conflicts with Appendix 1: a food-contact-compliant oral container could simultaneously qualify for abbreviated testing (Table A.1.2) and trigger expanded indirect-contact testing (Section 3.5), with no guidance on which prevails.
Recommendations:
1.Define a quantitative threshold (permeability coefficient, WVTR, or OTR), ideally referencing USP <671>.
2.Clarify scope — material, container system, or system plus secondary packaging.
3.Address transient-contact devices (oral syringes, dosing cups) explicitly.
4.Provide a decision tree showing how this interacts with Appendix 1’s abbreviated pathway.
Closing this gap before Step 4 would meaningfully improve consistency across regions and sectors.