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Gamma Sterilized Fully Customizable GMP Single Use Bioprocess Bags With Bottom Stirred

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Gamma Sterilized Fully Customizable GMP Single Use Bioprocess Bags With Bottom Stirred

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 FDA GMP

Material:

Renolit 9101

Certification:

GMP, ISO,FDA

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)

Packaging Details:

Double LDPE Bags+Carton

Supply Ability:

1000pcs/month

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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

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

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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Tropical Blister Foil

Cold Form Blister Packaging

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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

Gamma Sterilized Fully Customizable GMP Single Use Bioprocess Bags With Bottom Stirred

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