Recommendations on Elements That May Be Considered in the Risk Assessment Process for Specific Materials Used in Pharmaceutical Packaging or Manufacturing Systems
| Material | Elements that May Require a PDE* | Elements that May be Considered for Quantitation |
|---|---|---|
| ABS | None | Mg |
| Glass | None | Al, Ba, Ca, Fe, Mg, Si, Zr |
| PC | None | Ca, Si, Zn |
| PET | Co2 | Co2, Sb |
| PE | None | Al, Ca, Cr, Pb1 |
| PES | None | None |
| PP | None | Al, Ti |
| PMMA/Acrylic | None | Ca, Mg, Si |
| PTFE | None | Ca, Fe |
| Rubber elastomers | None | Al, B, Ca, Mg, S, Si, Zn |
| Multi-laminate polyolefins | Pb1 | Cr, Pb1 |
| PVC | Cd1 | Ca, Zn |
| Silicone | None | Si |