Quick Detail
Material: Medical-grade Renolit 9101 multi-layer composite film
Core Advantages: Bottom-mounted stirrer (uniform mixing/low shear), fully customizable (bag type/stirrer/tubing), biocompatible , Gamma-sterilized , double-welded leak-proof seal
Compliance: GMP, ISO,FDAApplication: High-density cell culture (CHO, CAR-T, Vero), monoclonal antibody production, bioprocess mixing
Key Features: 100% helium integrity testing, low extractables/leachables, animal-derived component-free (ADCF), pre-installed sensor options (pH/DO)
Custom Options: Bag type (2D/3D), bottom stirrer (marine/turbine/anchor), tubing (TPE/silicone, custom ID/length), connectors (TC25/50, Luer lock,etc)
Safety: Endotoxin <0.25 EU/mL, no DNase/RNase, cell adsorption <5%
Production Environment: Class C+A clean room
Description
In biopharmaceutical upstream processes, bottom-stirred bioreactors are critical for uniform mixing, high oxygen transfer, and low shear—yet off-the-shelf bags often fail to match custom hardware or sensitive cell needs, while poor seals/sterility risk batch failure. Traditional stainless steel systems demand costly CIP/SIP validation and risk cross-contamination.
Our Type A Disposable Bioreactor Bags with bottom-mounted stirrers, built with Renolit 9101 film, solve these issues with tailored performance and reliable compliance.
The defining bottom-stirrer design delivers superior mixing: marine impellers for suspension cells (low shear, even for shear-sensitive CAR-T), turbine impellers for high-density microbial culture (enhanced kLa), or anchor impellers for microcarrier-based adherent cells to prevent sedimentation. Double-welded seams + port connections, plus 100% helium integrity testing, eliminate micro-leaks during agitation.
Every bag is Gamma-sterilized (25-40 kGy) and pre-sterilized in double-layer packaging, cutting setup time by 40% vs. stainless steel systems.
Customization is fully supported: select 2D (5L-50L, R&D) or 3D (100L-2000L, commercial) bag types; tailor stirrer geometry, tubing ID/length, and connector types to fit mainstream hardware (Thermo, Cytiva, Sartorius). Manufactured in a Class C+A clean room, the bags meet ADCF, low E&L, and endotoxin <0.25 EU/mL standards, supporting regulatory submissions for ATMPs and biopharmaceuticals. Whether for CHO antibody production, CAR-T cell expansion,, these Type A bags deliver consistent mixing, leak-proof reliability, and plug-and-play integration.
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Gamma Sterilized Fully Customizable GMP Single Use Bioprocess Bags With Bottom Stirred Images
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