Page 101 - Assurance of Sterility for Sensitive Combination Products and Materials

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impermeable
material may
(max temp)
be used

or Beta radiation
Gamma/E-Beam
material may be
impermeable
used
No
No
No
No
No
√
incompatible
materials are
fibre based
Peroxide
(Plasma)
natural
Highlights material compatibility with various sterilization methods [27]—Cont’d
No
√
√
√
√
√
at least a part of
specification
specification
the packaging
permeable to
See suppliers
See suppliers
See suppliers
needs to be
EO/FORM
gas
√
√
√
permeable to
needs to be
packaging
part of the
at least a
STEAM Dry Heat Hydrogen Assurance of sterility for sensitive combination products and materials specification √ √ See suppliers √ specification No No See suppliers √ specification √ √ See suppliers √ specification
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