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.

POLYELITE ISOOur Quality Management system is certified by TÜV SÜD

hPOLYELITEhproduction factory

POLYELITE production facility;
Medix Showa Co., Ltd.

- PRODUCTS -

Polyethylene-based Film and Bag for Steam Sterilization

POLYELITE AE1
œ Applicable to a wide range of temperatures from -80ºC to +125ºC
œ Excellent mechanical properties at very low temperature
œ Good transparency after steam sterilization
œ Very low extractables and leachables
œ Adapted to high speed processing

œ JP Polyethylene or polypropylene containers for aqueous injections
œ USP <661> Physicochemical tests
œ USP <87> Biological reactivity tests, in vitro
œ USP <88> Biological reactivity tests, in vivo; Plastic Class ‡Y
œ EP 3.2.2.1. Plastic containers for aqueous solutions for infujion
œ US FDA Drug Master File

POLYELITE EH
œ Made of Polyethylene resins only
œ Applicable to a wide range of temperatures from -80ºC to +123ºC
œ Excellent mechanical properties at very low temperature
œ Extremely low extractables and leachables

œ JP Polyethylene or polypropylene containers for aqueous injections
œ US FDA Drug Master File
Sorption-free Bag for Steam Sterilization

POLYELITE EHC
œ Cyclo-olefin polymer layer as a contact layer
œ Extremely low sorption of lipid-soluble drug substances
œ Excellent transparency after steam sterilization
œ Extremely low extractables and leachables

œ JP Polyethylene or polypropylene containers for aqueous injections
œ USP <661> Physicochemical tests
œ USP <87> Biological reactivity tests, in vitro
œ USP <88> Biological reactivity tests, in vivo; Plastic Class ‡Y
œ EP 3.2.2.1. Plastic containers for aqueous solutions for infujion
œ US FDA Drug Master File
Polyethylene-based Film and Bag for Bio-pharmaceuticals

POLYELITE EL
œ Additive-free polyethylene film and bag
œ Excellent mechanical properties at very low temperature
œ Applicable to storage at liquid nitrogen temperature
œ Extremely low extractables and leachables

œ JP Polyethylene or polypropylene containers for aqueous injections
œ USP <661> Physicochemical tests
œ USP <87> Biological reactivity tests, in vitro
œ USP <88> Biological reactivity tests, in vivo; Plastic Class ‡Y
œ US FDA Drug Master File

POLYELITE AB2
œ Good barrier properties for Oxygen and Carbon Dioxide
œ Additive-free polyethylene layer as a contact layer

œ JP Polyethylene or polypropylene containers for aqueous injections
œ USP <661> Physicochemical tests
œ USP <87> Biological reactivity tests, in vitro
œ USP <88> Biological reactivity tests, in vivo; Plastic Class ‡Y
œ US FDA Drug Master File
Polypropylene Film and Bag for Steam Sterilization

POLYELITE AP
œ Good mechanical properties at low temperature
œ Excellent transparency after steam sterilization

œ JP Polyethylene or polypropylene containers for aqueous injections
œ USP <661> Physicochemical tests
œ USP <87> Biological reactivity tests, in vitro
œ USP <88> Biological reactivity tests, in vivo; Plastic Class ‡Y
œ EP 3.2.2.1. Plastic containers for aqueous solutions for infujion
œ US FDA Drug Master File
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