Shandong Huazhilin Pharmaceutical Technology Co.,Ltd
| Payment Terms | L/C,T/T |
| Supply Ability | 1000pcs/month |
| Delivery Time | 15-20days |
| Packaging Details | Double LDPE Bags+Carton |
| Material | Renolit 9101 |
| Capacity Range | 5L - 2000L |
| Sterilization | Gamma irradiation |
| Safety Indicators | Endotoxin <0.25 EU/mL; no DNase/RNase; |
| Shelf Life | 2 years (10-25℃, dry, dark storage) |
| Brand Name | Hagilin |
| Model Number | Customerized |
| Certification | GMP, ISO,FDA |
| Place of Origin | China |
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Product Specification
| Payment Terms | L/C,T/T | Supply Ability | 1000pcs/month |
| Delivery Time | 15-20days | Packaging Details | Double LDPE Bags+Carton |
| Material | Renolit 9101 | Capacity Range | 5L - 2000L |
| Sterilization | Gamma irradiation | Safety Indicators | Endotoxin <0.25 EU/mL; no DNase/RNase; |
| Shelf Life | 2 years (10-25℃, dry, dark storage) | Brand Name | Hagilin |
| Model Number | Customerized | Certification | GMP, ISO,FDA |
| Place of Origin | China | ||
| High Light | gmp single use bioprocess bags ，gamma disposable bioreactor bags ，gamma single use bioprocess bags | ||
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.
Company Details
Business Type:
Manufacturer
Year Established:
2009
Total Annual:
3000000-5000000
Employee Number:
50~100
Ecer Certification：
Verified Supplier
Shandong Huazhilin Pharmaceutical Technology Co., Ltd., was established in May 2009 with the mission of "providing pharmaceutical packaging and sterile consumables process solutions for pharmaceutical enterprises." It specializes in high-end pharmaceutical packaging, sterile preparations, sterile pr... Shandong Huazhilin Pharmaceutical Technology Co., Ltd., was established in May 2009 with the mission of "providing pharmaceutical packaging and sterile consumables process solutions for pharmaceutical enterprises." It specializes in high-end pharmaceutical packaging, sterile preparations, sterile pr...
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