Advantage
Needle-puncture sealed design eliminates open exposure, significantly reducing microbial contamination risk.
- Pre-sterilized & ready-to-use:Gamma irradiation sterilized (25–40 kGy), supplied in sterile packaging
- Representative sampling:Zero dead volume, no residual fluid, delivers true process samples
- Low endotoxin:≤ 2.15 EU/unit, meets high-purity pharmaceutical requirements
- Compatible with high-viscosity fluids:.2 mm large-bore needle for high-density cell suspensions
- Flexible customization:Manifold sampling, custom volumes and tailored connectors available
Application
Ideal for aseptic sampling during production or storage of biologic products manufactured with stainless steel infrastructure:
- Stainless steel seed and production bioreactors
- Stainless steel preparation and storage tanks for buffers and culture media
- Storage and preparation tanks for process intermediates and semi-finished products
Features
- System components: Needled sampling bags, Sampling port bracket and Seal caps
- Multiple specifications:Sampling needle sizes: 1 mm, 2 mm; Standard bag volumes: 50 mL, 100 mL, 250 mL, 500 mL, 1000 mL; Sampling port bracket : TC50 (5-port), TC65 (9-port)
- Customizable options available
- Comprehensive validation documentation available
- Material safety: Product contact components comply with USP <87> and USP <88> Class VI plastics biocompatibility requirements
- Wide temperature tolerance: -80 °C to + 50 °C
- Long shelf life: 3 years for sampling bags; 5 years for Seal caps
Composition
The LeCouple™ KY Aseptic Sampling System primarily includes: Needle sampling bag, Sampling port bracket,Assembly and Seal cap.
To further meet diverse customer needs, LePure also offers manifold sampling bags and manifold sampling bottles,delivering highly flexible customized solutions for specific application scenarios.