HOSOKAWA YOKO CO.,Ltd.

Products

polyelite

Primary Containers

High-quality and Functional Non-PVC Films and Bags for Primary Packaging of Pharmaceuticals

Primary Containers

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.

tuv

“TÜV SÜD” ISO 13485, ISO 9001
Hosokawa Yoko Co., Ltd. and Medix Showa Co., Ltd. have received ISO 13485:2003 certification, which scope is "Design and Development, Production and Distribution of Plastic Medical containers and Devices for Parenteral Infusion" and ISO 9001:2008 certification which sope is "Design and Development, Production and Distribution of Plastic Containeres and Devices for Parenteral Infussion and Packaging Materials for Medical and Industrial Products"

PMedix Showa Co., Ltd.

POLYELITE™ production facility; Medix Showa Co., Ltd.

Products

Polyethylene-based Film and Bag for Steam Sterilization

POLYELITE™ AE1

POLYELITE AE1
  • Applicable to a wide range of temperatures from -80℃ to +125℃
  • Excellent mechanical properties at very low temperature
  • Good transparency after steam sterilization
  • Very low extractables and leachables
  • Adapted to high speed processing
  • JP Polyethylene or polypropylene containers for aqueous injections
  • USP <661> Physicochemical tests
  • USP <87> Biological reactivity tests, in vitro
  • USP <88> Biological reactivity tests, in vivo; Plastic Class VI
  • EP 3.2.2.1. Plastic containers for aqueous solutions for infusion
  • US FDA Drug Master File

POLYELITE™ EH

POLYELITE EH
  • Made of polyethylene resins only
  • Applicable to a wide range of temperatures from -80℃ to +123℃
  • Excellent mechanical properties at very low temperature
  • Extremely low extractables and leachables
  • JP Polyethylene or polypropylene containers for aqueous injections
  • US FDA Drug Master File

Sorption-free Bag for Steam Sterilization

POLYELITE™ EHC

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

Polyethylene-based Film and Bag for Bio-pharmaceuticals

POLYELITE™ EL

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

POLYELITE™ AB2

POLYELITE AB2
  • Good barrier properties for Oxygen and Carbon Dioxide
  • Additive-free polyethylene layer as a contact layer
  • JP Polyethylene or polypropylene containers for aqueous injections
  • USP <661> Physicochemical tests
  • USP <87> Biological reactivity tests, in vitro
  • USP <88> Biological reactivity tests, in vivo; Plastic Class VI
  • US FDA Drug Master File

Polypropylene Film and Bag for Steam Sterilization

POLYELITE™ AP

POLYELITE AP
  • Good mechanical properties at low temperature
  • Excellent transparency after steam sterilization
  • JP Polyethylene or polypropylene containers for aqueous injections
  • USP <661> Physicochemical tests
  • USP <87> Biological reactivity tests, in vitro
  • USP <88> Biological reactivity tests, in vivo; Plastic Class VI
  • EP 3.2.2.1. Plastic containers for aqueous solutions for infusion
  • US FDA Drug Master File