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Renolit 9109 Sampling & Cryopreservation Bags Disposable Gamma Sterilized For Biopharmaceutical & Cell Sample

Renolit 9109 Sampling & Cryopreservation Bags Disposable Gamma Sterilized For Biopharmaceutical & Cell Sample

Brand Name: Hagilin
Model Number: Customerized
MOQ: 1pcs
Price: Negotiable
Payment Terms: L/C,T/T
Supply Ability: 100000pcs/year
Detail Information
Place of Origin:
Hagilin
Certification:
FDA ISO GMP
Material:
Renolit 9109 Multi-layer Film (ULDPE Contact, Barrier Core)
Capacity Range:
50mL – 50L
Sterilization:
Gamma Irradiation (25–40 KGy)
Tubing Options:
TPE/silicone (Custom OD.,ID, Length); Sterile, Kink-resistant
Shelf Life:
GMP, ISO,FDA
Packaging Details:
Double LDPE Bags+Carton
Supply Ability:
100000pcs/year
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Product Description

Renolit 9109 Sampling & Cryopreservation Bags – Gamma Irradiated (25–40 kGy), Multi-Layer Film, GMP ISO FDA Compliant for Biopharmaceutical Storage

Renolit 9109 Sampling & Cryopreservation Bags
Disposable, gamma-sterilized, biocompatible bags designed for biopharmaceutical and cell sample storage and collection, manufactured under GMP certification.
Product Overview

Advanced dual-purpose sampling and cryopreservation bags engineered for biopharmaceutical and cell therapy applications, featuring superior low-temperature performance and sterile sampling capabilities.

Material Composition

Medical-grade Renolit 9109 multi-layer composite film with ULDPE liquid-contact layer and core barrier layer, optimized for ultra-low temperature applications (-196°C LN₂ to 45°C thawing) with minimal sample adsorption.

Quality & Compliance

GMP certified, ISO compliant, FDA low E&L compliant with BPOG guidelines, manufactured in Class C+A clean room environment.

Sterilization & Safety

Gamma-sterilized (SAL 10⁻⁶), animal-derived component-free (ADCF), endotoxin levels <0.25 EU/mL, DNase/RNase-free.

Key Performance Features
  • Dual-purpose design for both sampling and cryopreservation workflows
  • Excellent low-temperature flexibility and tear resistance
  • Double-welded leak-proof seals for maximum integrity
  • 100% helium leak testing (detects ≥2μm defects)
  • Freeze-thaw cycle resistance (≥10 cycles)
  • Cell adsorption <3% with ≥90% cell viability post-thaw
  • LN₂ immersion-safe without brittleness concerns
Applications
Cell Therapy
Bioreactor Harvest Sampling
Monoclonal Antibody Storage
Viral Vector Aliquoting
Blood & Biological Fluid Cryopreservation
Customization Options
Feature Available Options
Capacity 5mL to 500mL
Sampling Ports Luer lock, TC25, AseptiQuik®
Tubing TPE, silicone (custom ID/length)
Bag Shape Flat or stand-up configurations
Labeling Custom label areas compatible with barcode/QR code systems
Technical Advantages

The Renolit 9109 multi-layer film's ULDPE contact layer ensures minimal protein and cell adsorption (<3%), preserving sample potency while the core barrier layer maintains moisture control and prevents gas permeation. This is critical for preserving media pH and cell viability during extended storage periods.

Integrated Sampling Functionality

Customizable ports and pre-sterilized tubing enable seamless, sterile sampling from bioreactors or process streams. The double-welded seams and reinforced seals prevent leaks during cryopreservation, even under extreme thermal stress conditions from -196°C to 45°C.