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GMP Certified Disposable Bioreactor Bag Leak Proof Design 1L To 2000L

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GMP Certified Disposable Bioreactor Bag Leak Proof Design 1L To 2000L

Brand Name:	Hagilin
Model Number:	Customerized
MOQ:	1PCS
Price:	Negotiable
Payment Terms:	L/C,T/T
Supply Ability:	1000pcs/month

Detail Information

Product Description

Detail Information

Place of Origin:

China

Certification:

ISO GMP FDA

Material:

Renolit 9101 Multi-layer Composite Film

Certification:

FDA ISO GMP

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)

Packaging Details:

Double LDPE Bags+Carton

Supply Ability:

1000pcs/month

Highlight:

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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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Pharmaceutical Aluminum Foil

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Tropical Blister Foil

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products details

Tyvek Sterilization Bags

Easy Peel Pouch and Lid

Tyvek Lid

Easy Tear Packaging

Medical Silicone Tubing

TPE Medical Tubing

Oxide Coated Film Rolls

Pharmaceutical Aluminum Foil

Disposable Bioreactor Bags

Cryogenic Freezing Bags

Single Use Bioprocess Bags

Transfer Bag

LDPE Packaging Bag

Tropical Blister Foil

Cold Form Blister Packaging

PTP Blister Foil

GMP Certified Disposable Bioreactor Bag Leak Proof Design 1L To 2000L

disposable bioreactor bag leak proof

gmp disposable bioreactor bag

gmp disposable bioreactor bags