Quick Detail
Material: Medical-grade Renolit 9109 multi-layer composite film (liquid-contact layer: ULDPE; core barrier layer; ), optimized for ultra-low temperature (-196℃ LN₂ to 45℃ thawing) and minimal sample adsorption.
Core Advantages: Dual-purpose for sampling & cryopreservation, Renolit 9109’s low-temperature flexibility/tear resistance, Gamma-sterilized (SAL 10⁻⁶), USP Class VI biocompatibility, double-welded leak-proof seal, customizable ports/tubing for sampling workflows.
Compliance: GMP, ISO,FDA low E&L compliant with BPOG guidelines.
Application: Cell therapy (CAR-T/CAR-NK) sampling & cryopreservation, bioreactor harvest sampling, monoclonal antibody (mAb) intermediate storage, viral vector aliquoting, blood/biological fluid cryopreservation.
Key Features: 100% helium leak testing (detects ≥2μm defects), animal-derived component-free (ADCF), endotoxin <0.25 EU/mL, no DNase/RNase, freeze–thaw cycle resistance (≥10 cycles), peelable sampling port option.
Custom Options: Capacity (5mL–500mL), sampling port (Luer lock/TC25/AseptiQuik®), tubing (TPE/silicone, custom ID/length), bag shape (flat/stand-up), label area (barcode/QR code compatible).
Safety: Cell adsorption <3%, maintains ≥90% cell viability post-thaw, LN₂ immersion-safe without brittleness.
Description
Biopharmaceutical and cell therapy workflows demand reliable sampling and cryopreservation tools that preserve sample integrity, avoid contamination, and withstand extreme temperatures. Off-the-shelf bags often lack low-temperature durability, flexible sampling ports, or compatibility with both LN₂ and ultra-low freezers, risking sample loss or cross-contamination. Traditional rigid containers are bulky and hard to integrate with closed sampling systems.
Our Renolit 9109 Sampling & Cryopreservation Bags solve these pain points with a dual-purpose design built for both sampling and long-term cryopreservation. The Renolit 9109 multi-layer film’s ULDPE contact layer ensures minimal protein/cell adsorption (<3%), preserving sample potency, while its core barrier layer locks in moisture and prevents gas permeation—critical for maintaining media pH and cell viability during storage. The thickness balances flexibility and durability, resisting tearing even after repeated freeze–thaw cycles (≥10 cycles) and LN₂ immersion (-196℃).
A key highlight is the integrated sampling functionality: customizable ports (Luer lock for manual sampling, AseptiQuik® for closed-system transfer, TC25 for bioreactor connections) and pre-sterilized tubing enable seamless, sterile sampling from bioreactors or process streams. Once sampled, the double-welded seams and reinforced seal prevent leaks during cryopreservation, even under thermal stress from -196℃ to 45℃. Every bag undergoes Gamma sterilization (25–40 kGy, SAL 10⁻⁶) and 100% helium integrity testing to eliminate micro-leaks and contamination risks.
Manufactured in a Class C+A clean room, these bags meet ADCF, low E&L, and strict endotoxin standards (<0.25 EU/mL), supporting regulatory submissions for ATMPs and biopharmaceuticals. Whether for small-volume sampling (5mL) or mid-scale cryopreservation (500mL), they offer closed-system safety, sample integrity, and workflow flexibility—eliminating the need for separate sampling and cryo containers.