GMP Certified Disposable Bioreactor Bag Leak Proof Design 1L To 2000L
Price:
Negotiable
MOQ:
1PCS
Delivery Time:
15-20days
Brand:
Hagilin
Product Description
GMP Certified Disposable Bioreactor Bags with Leak-Proof Design and Customizable Capacity from 1L to 2000L
Renolit 9101 Film Disposable Bioreactor Bags
Advanced single-use bioreactor bags engineered for leak-proof performance and contamination reduction in critical bioprocessing applications.
Core Specifications
| Material | Medical-grade Renolit 9101 multi-layer composite film |
| Compliance | GMP ISO FDA |
| Production Environment | Class C+A clean room |
Key Advantages
- Leak-proof design with double-welded seal technology
- Contamination-free single-use construction
- Broad cell compatibility for diverse applications
- 100% integrity testing for quality assurance
- Gamma-sterilized (25-40 kGy) for immediate use
- Low extractables and leachables
- Endotoxin levels <0.25 EU/mL
- Low protein adsorption
- Cell culture-safe materials
Customization Options
- Capacity range: 1L to 2000L
- Custom aeration types (microbubbles/macrobubbles)
- Integrated sensors (pH/DO) for real-time monitoring
- Various tubing and connector configurations
Applications
Cell Culture Bioprocessing Vaccine Production ATMP Manufacturing CAR-T Cell Therapy CHO Cell Culture
Technical Overview
In biopharmaceutical and cell therapy production, maintaining sterility, preventing leaks, and ensuring cell viability are critical challenges. Traditional stainless steel bioreactors risk cross-contamination due to complex cleaning validation requirements, while low-quality disposable bags may suffer from seal failure or material incompatibility.
Our Disposable Bioreactor Bags with Renolit 9101 Film are engineered to solve these challenges, featuring double-welded seal technology with 100% integrity testing that detects defects as small as 30μm. This ensures no seepage during high-volume agitation or long-term culture cycles.
The medical-grade Renolit 9101 multi-layer composite film provides exceptional biocompatibility and barrier performance. Manufactured in Class C+A clean room environments, these bags support regulatory submissions for Advanced Therapy Medicinal Products (ATMPs) and biopharmaceuticals, delivering reliable sterility, leak protection, and scalability from research to commercial production.
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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