POLYELITE®

Primary Containers

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

POLYELITE®

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

Compliance of ISO 9001 and 15378
Medix Showa Co., Ltd. has received ISO 15378:2017 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

  • 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

  • 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

  • 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 Co., Ltd. R&D teams will challenge new developments as per customer’s specific request.
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