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 multi-layer composite film |
| Capacity Range | 1L - 2000L |
| Seal Technology | Double-welded seams + double-welded port connections; 100% integrity testing |
| Sterilization | Gamma irradiation (25-40 kGy) |
| Safety Indicators | Endotoxin <0.25 EU/mL; No DNase/RNase |
| Shelf Life | 2 years (stored in cool, dry, dust-free environment) |
| Brand Name | Hagilin |
| Model Number | Customerized |
| Certification | FDA ISO GMP |
| Place of Origin | China |
View Detail Information
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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 multi-layer composite film | Capacity Range | 1L - 2000L |
| Seal Technology | Double-welded seams + double-welded port connections; 100% integrity testing | Sterilization | Gamma irradiation (25-40 kGy) |
| Safety Indicators | Endotoxin <0.25 EU/mL; No DNase/RNase | Shelf Life | 2 years (stored in cool, dry, dust-free environment) |
| Brand Name | Hagilin | Model Number | Customerized |
| Certification | FDA ISO GMP | Place of Origin | China |
| High Light | disposable bioreactor bag leak proof ，gmp disposable bioreactor bag ，gmp disposable bioreactor bags | ||
Quick Detail
Material: Medical-grade Renolit 9101 multi-layer composite film
Core Advantages: Leak-proof (double-welded seal), contamination-free (single-use), broad cell compatibility, customizable capacity
Compliance: GMP, ISO FDA
Application: Cell culture, bioprocessing, vaccine production, ATMP (Advanced Therapy Medicinal Products) manufacturing
Key Features: 100% integrity testing, gamma-sterilized, low extractables/leachables
Custom Options: Capacity (1L-2000L), aeration type customerized, integrated sensors (pH/DO), tubing/connector types
Safety: Endotoxin <0.25 EU/mL, low protein adsorption, cell culture-safe
Production Environment: Class C+A clean room
Description
In biopharmaceutical and cell therapy production (e.g., CAR-T, CHO cell culture), maintaining sterility, preventing leaks, and ensuring cell viability are critical challenges. Traditional stainless steel bioreactors risk cross-contamination (due to complex CIP/SIP validation) and lack flexibility, while low-quality disposable bags suffer from seal failure (causing costly liquid loss) or material incompatibility (harming sensitive cells). These issues lead to batch rejection, regulatory non-compliance, and delayed commercialization of life-saving therapies.
Our Disposable Bioreactor Bags with Renolit 9101 Film are engineered to solve these pain points, designed for safe, scalable cell culture and bioprocessing. The core of the bag is medical-grade Renolit 9101 multi-layer composite film—proven in industry applications for its exceptional biocompatibility and barrier performance.
To eliminate leaks, the bags feature double-welded seal technology: all seams and port connections are welded twice via precision heat-sealing, then undergo 100% integrity testing (pressure hold + vacuum decay) to detect defects as small as 30μm—ensuring no seepage even during high-volume agitation or long-term culture. The single-use design eliminates cross-contamination risks, as each batch uses a new, pre-sterilized (gamma irradiation 25-40 kGy) bag
The bags support flexible customization to match diverse processes: choose from aeration pores (20μm microbubbles for suspension cells, 1mm macrobubbles for microcarrier cultures), integrate pH/DO sensors for real-time process monitoring, or adjust capacity (1L-2000L) for R&D, clinical, or commercial-scale production. Manufactured in a Class C+A clean room, they meet strict safety standards—endotoxin <0.25 EU/mL, low extractables (compliant with FDA ISO), and no harmful additives—supporting regulatory submissions for ATMPs and biopharmaceuticals. Whether for CAR-T cell manufacturing, CHO cell-based antibody production, or vaccine development, these Renolit 9101 bioreactor bags deliver reliable sterility, leak protection, and scalability.
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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