HOSOKAWA YOKO CO.,Ltd.

Products

polyelite

Primary Containers

High-quality and Functional ready-to use bags for IV drugs

Primary Containers

POLYELITE® is the brand of primary packaging for pharmaceutical applications with excellent propeties and safeness.

Compliance of ISO 9001 and 13485
Hosokawa Yoko Co., Ltd. and Medix Showa Co., Ltd. have received ISO 13485:2016 certification, which scope is "Design and development, manufacture and distribution of Infusion bag" and ISO 9001:2015 certification which scope is "Design and development, production and distribution of plastic containers".

POLYELITE® is registered in DMF.

PMedix Showa Co., Ltd.

production facility : Medix Showa Co., Ltd. (Nagano, Japan)
POLYELITE® is manufactured in the ISO class 7 clean room.

Products

Polyethylene Bag for Steam Sterilization

POLYELITE® TH82

POLYELITE
  • 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 7.02-2.1 Polyethylene or Polypropylene Containers for Aqueous Injection
  • USP<661.2> Plastic Packaging System for Pharmaceutical Use
  • USP<87> Biological Reactivity Tests, in vitro
  • USP<88> Biological Reactivity Test, in vivo, Plastic Class VI
  • USP<85> Bacterial Endotoxins Test
  • USP<788> Particulate matter in injections
  • EP 3.2.2.1. Plastic Containers for Aqueous Solutions for Infusion

Sorption-free Bag for Steam Sterilization

POLYELITE® PHC

POLYELITE PHC
  • 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 7.02-2.1 Polyethylene or Polypropylene Containers for Aqueous Injection
  • USP<661.2> Plastic Packaging System for Pharmaceutical Use
  • USP<87> Biological Reactivity Tests, in vitro
  • USP<88> Biological Reactivity Test, in vivo, Plastic Class VI
  • USP<85> Bacterial Endotoxins Test
  • USP<788> Particulate matter in injections
  • EP 3.2.2.1. Plastic Containers for Aqueous Solutions for Infusion

Polyethylene 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

HOSOKAWA YOKO R&D teams will challenge new developments as per customer's specific request.

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