Single-Use Liquid Storage and Shipping Bags

We offer the Lifecube® 2D/3D Standard Single-Use Storage and Shipping Bags in a range of sizes from 50 ml to 3000 l for the biopharmaceutical industry. Our single-use bioprocess bags are constructed of a five-layer Lifemeta® KA film, with ULDPE as the fluid contact material and EVOH as the gas barrier layer. The outer protective HDPE layer is to optimize overall toughness of the bag. These single-use bioprocess bags are produced in ISO Class 7 cleanroom that is ISO 9001 compliant.

Lifemeta® KA Film (Blown Film)

The Lifemeta® KA films of single-use bags are composed of five layers.

Quality Assurance

  • ISO 9001:2015 quality management system
  • ISO Class 7 clean zone
  • 100% leak testing
  • ADCF raw materials
  • Meet FDA Indirect Food Additive requirements cited in 21 CFR 177-182
  • Meet requirement of USP <87> In Vitro Biological Reactivity Test
  • Meet requirement of USP <88> Biological Reactivity Test for Class VI plastics
  • Aqueous extraction contains < 0.25 EU/ml as determined by Limulus Amebocyte Lysate (LAL), USP <85>
  • Particulate matter in the product eluent meets the requirements in USP <788> for large volume parenterals
  • Verify gamma irradiation dose according to ISO 11137
  • Provide product validation guide and certificate of quality 

Features

  • Good physical strength and excellent biological safety
  • Integrated bag body designed for Lifecube® 2D/3D single-use bags and less residual liquid
  • Double-layer sterile packaging sterilized by 25-45 kGy gamma irradiation
  • Variable and flexible customized services
  • Various and scalable

Typical Applications

  • Buffer and media storage and transfer after filtration
  • Intermediates storage 
  • Stock solution storage
  • Formulation filling