Renolit 9109 Sampling & Cryopreservation Bags Disposable Gamma Sterilized For Biopharmaceutical & Cell Sample
Renolit 9109 Sampling & Cryopreservation Bags – Gamma Irradiated (25–40 kGy), Multi-Layer Film, GMP ISO FDA Compliant for Biopharmaceutical Storage
Advanced dual-purpose sampling and cryopreservation bags engineered for biopharmaceutical and cell therapy applications, featuring superior low-temperature performance and sterile sampling capabilities.
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.
GMP certified, ISO compliant, FDA low E&L compliant with BPOG guidelines, manufactured in Class C+A clean room environment.
Gamma-sterilized (SAL 10⁻⁶), animal-derived component-free (ADCF), endotoxin levels <0.25 EU/mL, DNase/RNase-free.
- 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
| 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 |
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.
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.
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