Gamma Sterilized Fully Customizable GMP Single Use Bioprocess Bags With Bottom Stirred
Price:
Negotiable
MOQ:
1PCS
Delivery Time:
15-20days
Brand:
Hagilin
Product Description
Gamma-Sterilized Fully Customizable GMP Certified Disposable Bioreactor Bags with Bottom-Stirred Design
Bottom-Stirred Type A Disposable Bioreactor Bags
Advanced disposable bioreactor bags featuring Renolit 9101 film construction, gamma sterilization, and complete customization options for optimal bioprocessing performance.
Core Specifications
Material: Medical-grade Renolit 9101 multi-layer composite film
Sterilization: Gamma-sterilized (25-40 kGy)
Certification: GMP Certified
Sterilization: Gamma-sterilized (25-40 kGy)
Certification: GMP Certified
Key Advantages
- Bottom-mounted stirrer design for uniform mixing with low shear stress
- Fully customizable configurations (bag type, stirrer, tubing, connectors)
- Biocompatible and animal-derived component-free (ADCF)
- Double-welded leak-proof seals with 100% helium integrity testing
- Low extractables and leachables for superior product safety
- Pre-installed sensor options (pH/DO) available
Applications
CHO Cell Culture CAR-T Cell Expansion Vero Cell Culture Monoclonal Antibody Production Bioprocess Mixing
Customization Options
| Component | Available Options |
|---|---|
| Bag Type | 2D (5L-50L for R&D) or 3D (100L-2000L for commercial) |
| Bottom Stirrer | Marine impellers (low shear), Turbine impellers (high kLa), Anchor impellers (microcarriers) |
| Tubing | TPE or Silicone, custom ID and length |
| Connectors | TC25/50, Luer lock, and other standard fittings |
Quality & Safety Standards
Endotoxin: <0.25 EU/mL
Cell Adsorption: <5%
Contaminants: No DNase/RNase detected
Production Environment: Class C+A clean room
Compliance: GMP, ISO, FDA standards
Cell Adsorption: <5%
Contaminants: No DNase/RNase detected
Production Environment: Class C+A clean room
Compliance: GMP, ISO, FDA standards
Technical Overview
In biopharmaceutical upstream processes, bottom-stirred bioreactors are essential for achieving uniform mixing, high oxygen transfer rates, and minimal shear stress. Traditional off-the-shelf bags often fail to match custom hardware requirements or accommodate sensitive cell lines, while inadequate seals and sterilization can jeopardize entire batches. Conventional stainless steel systems demand costly clean-in-place/steam-in-place validation and carry cross-contamination risks.
Our Type A Disposable Bioreactor Bags with bottom-mounted stirrers address these challenges through tailored performance and reliable compliance. The innovative bottom-stirrer configuration ensures superior mixing efficiency: marine impellers for suspension cells requiring low shear (ideal for CAR-T applications), turbine impellers for high-density microbial cultures with enhanced oxygen transfer, and anchor impellers for microcarrier-based adherent cells to prevent sedimentation.
Double-welded seams and port connections, combined with comprehensive helium integrity testing, eliminate micro-leaks during agitation processes. Each bag undergoes gamma sterilization (25-40 kGy) and is pre-sterilized in double-layer packaging, reducing setup time by 40% compared to traditional stainless steel systems.
Manufactured in Class C+A clean room environments, these bags meet stringent ADCF, low extractables/leachables, and endotoxin standards, supporting regulatory submissions for Advanced Therapy Medicinal Products (ATMPs) and biopharmaceuticals. Whether deployed in CHO antibody production or CAR-T cell expansion applications, these Type A bags deliver consistent mixing performance, leak-proof reliability, and seamless plug-and-play integration.
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Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.
Company
Shandong Huazhilin Pharmaceutical Technology Co.,Ltd
Location
Room 908, Jiamei Building, No. 1, South Shiji Road, Fujia Town, Economic Development Zone, Zibo City, Shandong Province, China
Contact Person
Wang