Page 99 - Assurance of Sterility for Sensitive Combination Products and Materials
P. 99

Laminated films, widely used for the manufacture of prefabricated sterile barrier systems (pouches, reels), impermeable
                                                       No
                                                              No
                                                                     √
                                                       √
                                                                     √
                                                              √
                                                          specification
                                                       See suppliers
                                                              √
                   √     No  No     No  √  √        √  √ See suppliers   specification     No  √  See suppliers   specification    see suppliers  see suppliers  See suppliers   specification specification specification  Package/container closures  Continued  85
                                                                     √
                             Film components, blister materials, high barrier composites, impermeable
                   √    √       √      √         √     √      √      √
                                                 see suppliers   specification  √ (121°C)
                   √    No      √      No                     No     √



                   PET/PP films  (PET/Polypropylene)  PET/PE films  (PET/Polyethylene)  Aluminium laminates   and composites, i.e.   high barrier materials  APET film  (Amorphous   Polyethylene   T erephthlate)  E/P  (Ethylene-Propylene   Copolymer)  HDPE film  (High Density   Polyethylene)  LDPE film  Low Density   Polyethylene  PA film (com
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