Page 98 - Assurance of Sterility for Sensitive Combination Products and Materials

84 Assurance of sterility for sensitive combination products and materials

Dry Heat (max temp) impermeable material may be used √ (160°C) no No No

Gamma/E-Beam or Beta radiation impermeable material may be used √ √ √ No Dry Heat (max temp) impermeable material may be used

Hydrogen Peroxide (Plasma) natural fibre based materials are incompatible No √ No √ Gamma/E- Beam or Beta radiation impermeable material may be used

Highlights material compatibility with various sterilization methods [27].

EO/FORM at least a part of the packaging needs to be permeable to gas √ √ √ √ Hydrogen Peroxide (Plasma) natural fibre based materials are incompatible

STEAM at least a part of the packaging needs to be permeable to steam √ √ (max. T 127°C) not suitable for hospitals √ √ EO/FORM at least a part of the packaging needs to be permeable to gas

Permeability sufficient for steam and gaseous sterilisation methods √ √ √ √ STEAM at least a part of the packaging needs to be permeable to steam

Materials with gas and steam permeability Medical grade paper Flush spunbond non- woven materials of polyethylene Wet laid non-wovens (pulp and plastic SMS (Spunbond Meltblown Spunbond) non- woven materials of polypropylene Films and composite

Table 5.1 fibres) films