Page 102 - Assurance of Sterility for Sensitive Combination Products and Materials

86 Assurance of sterility for sensitive combination products and materials

Dry Heat (max temp) impermeable material may be used

Gamma/E-Beam or Beta radiation impermeable material may be used No No √ No No No √ No √

Hydrogen Peroxide (Plasma) natural fibre based materials are incompatible √ No √ √ √ √ √ No √

Highlights material compatibility with various sterilization methods [27]—Cont’d

EO/FORM at least a part of the packaging needs to be permeable to gas √ √ √ See suppliers specification See suppliers specification See suppliers specification See suppliers specification See suppliers specification See suppliers specification

STEAM at least a part of the packaging needs to be permeable to steam √ √ √ √ √ √ √ √ √

Permeability sufficient for steam and gaseous sterilisation methods No √ √ No No No √ No No

Materials with gas and steam permeability PE film (component) PP film (component) PET film (component) T eraphthalete) PETG (PETG-Foam, PETG-PE) film Polystyrene) (Poly Vinyl Chloride) Polyurethane)

Table 5.1 (Polyethylene) (Polypropylene) (Polyethylene (PET Glycol) PS film (Polystyrene) HIPS film (High Impact PC film (Polycarbonate) PVC film TPU film (Thermoplastic