2D Single-use Bag for Biopharmaceuticals

2D Single-use Bag for Biopharmaceuticals

Introduction
The 2D liquid storage bag adopts multi-layer coextrusion film, which ensures the extremely low gas permeability, good physical strength, wide range of chemical compatibility and biocompatibility, so that it can be safely used for the storage and transportation of various biopharmaceutical liquids. Standard 2D storage bags are s series and H series, s series specification is 1l-50l, H series is 5ml-3l.

Feature
*The membrane material has good physical strength, chemical compatibility and biocompatibility
*High transparency film material, which is conducive to auxiliary process judgment
*It can meet the storage and transportation requirements of various solutions in biopharmaceutical process
*Flexible customized size and pipeline, suitable for various processes

Application
*Storage and transportation of small scale buffer and medium
*Collection of purified components
*Sample collection
*Temporary storage and transportation of bulk intermediate products
*Appropriate liquid-liquid mixing process
*Harvest, storage and transportation of stock solution
*Transportation of end products

Specification: S Series 1 L-50 L, H Series 5 ML-3 L, special specifications can be customized
Service temperature: - 80 ℃ ~ 60 ℃
Sterilization method: gamma ray irradiation sterilization (25-40 kGy)
Packaging form: double layer PE bag vacuum packaging

Membrane material information
Structure: LDPE / EVOH / ULDPE (liquid contact layer)
Thickness: 0.325 mm
Compliance:
ISO 10993-4: Haemolysis
ISO 10993-5: Cytotoxicity
ISO 10993-6: Implantation tests
ISO 10993-10: Irritation and Sensitization tests
ISO 10993-11: Acute systemic toxicity test
USP < 85 >: Bacterial endotoxins LAL test
USP < 88 >: Biological reactivity testing, in vivo, class VI
USP<661>：Plastic Containers European Pharmacopoeia tests, Ch.3.1.5
Plastics containers European Pharmacopoeia test chapter 3.1.5
ADCF: No animal derived ingredients

Production environment and basic packaging specification
*Production in 10000 clean workshop
*Endotoxin < 0.25eu/ml
*25kgy irradiation to ensure sterility
*Standard double independent packaging
*Two dimensional code is set on the outer package to facilitate the storage and scanning
*Perfect material traceability system