Aseptic Sampling Bags

Aseptic Sampling Bags

Masterfilter provides a completed solutions of sterile sampling solutions for collection and storage of small volume samples. The Lifecube™ Aseptic Sampling Bags are available from 5 ml to 1000 ml and constructed of a 11-layer Topene™ RB film, with ULDPE as the fluid contact material and EVOH as the gas barrier layer. The outer protective LDPE layer is to optimize the overall toughness of the bag. The single-use sampling bags are produced in a ISO Class 7 cleanroom that is ISO 9001 compliant.

Features

  • Good physical strength and great biological safety
  • Integrated bag body and minimal residual liquid
  • Double-layer packaging sterilized by 25-45 kGy gamma irradiation
  • Various choices for sampling application
  • Flexible customized solutions

Quality Assurance

  • ISO 9001:2015 quality management system
  • ISO Class 4.8 / ISO 7/ ISO 8 cleanroom production
  • 100% leak testing
  • ADCF raw materials, complies with FDA 21 CFR Part 177-182 (Indirect food additives)
  • Meet the requirement of current USP <87> Class VI, Biological Reactivity Test, In Vitro
  • Meet the criteria of current USP <88> Class VI, Biological Reactivity Test, In Vivo
  • 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
  • Verified gamma irradiation dose according to ISO 11137

Applications

  • Sampling with single-use bags
  • Secondary sampling from sampling bags
  • Store samples

Configurable Options

Aseptic Sampling Bags Options