POLYELITE
POLYELITE® is a range of polyolefin-based films and bags suitable for pharmaceutical packaging of solutions and drug infusion fluids with excellent properties ; transparency, flexibility and high impact strength.
Our Quality Management system is certified by TÜV SÜD
POLYELITE production facility;
Medix Showa Co., Ltd.
Polyethylene-based Film and Bag for Steam Sterilization
POLYELITE AE1
Applicable to a wide range of temperatures from -80ºC to +125ºC
Excellent mechanical properties at very low temperature
Good transparency after steam sterilization
Very low extractables and leachables
Adapted to high speed processing
USP <661> Physicochemical tests
USP <87> Biological reactivity tests, in vitro
USP <88> Biological reactivity tests, in vivo; Plastic Class Y
EP 3.2.2.1. Plastic containers for aqueous solutions for infujion
US FDA Drug Master File
POLYELITE EH
Made of Polyethylene resins only
Applicable to a wide range of temperatures from -80ºC to +123ºC
Excellent mechanical properties at very low temperature
Extremely low extractables and leachables
US FDA Drug Master File
Sorption-free Bag for Steam Sterilization
POLYELITE EHC
Cyclo-olefin polymer layer as a contact layer
Extremely low sorption of lipid-soluble drug substances
Excellent transparency after steam sterilization
Extremely low extractables and leachables
USP <661> Physicochemical tests
USP <87> Biological reactivity tests, in vitro
USP <88> Biological reactivity tests, in vivo; Plastic Class Y
EP 3.2.2.1. Plastic containers for aqueous solutions for infujion
US FDA Drug Master File
Polyethylene-based Film and Bag for Bio-pharmaceuticals
POLYELITE EL
Additive-free polyethylene film and bag
Excellent mechanical properties at very low temperature
Applicable to storage at liquid nitrogen temperature
Extremely low extractables and leachables
USP <661> Physicochemical tests
USP <87> Biological reactivity tests, in vitro
USP <88> Biological reactivity tests, in vivo; Plastic Class Y
US FDA Drug Master File
POLYELITE AB2
Good barrier properties for Oxygen and Carbon Dioxide
Additive-free polyethylene layer as a contact layer
USP <661> Physicochemical tests
USP <87> Biological reactivity tests, in vitro
USP <88> Biological reactivity tests, in vivo; Plastic Class Y
US FDA Drug Master File
Polypropylene Film and Bag for Steam Sterilization
POLYELITE AP
Good mechanical properties at low temperature
Excellent transparency after steam sterilization
USP <661> Physicochemical tests
USP <87> Biological reactivity tests, in vitro
USP <88> Biological reactivity tests, in vivo; Plastic Class Y
EP 3.2.2.1. Plastic containers for aqueous solutions for infujion
US FDA Drug Master File
