2.5D Single-use Bag for Pharmaceuticals

2.5D Single-use Bag for Pharmaceuticals

Introduction
The 2.5D barrel bag adopts multi-layer coextrusion film, which ensures the extremely low gas permeability, good physical strength, excellent chemical compatibility and biocompatibility of the sterile liquid storage bag, so that it can be safely used for the storage and transportation of various biopharmaceutical liquids. The standard 2.5D barrel liquid storage bag has various types and specifications of 38 l-568 L, which can be used independently for the storage of buffer solution, culture medium, intermediate product or stock solution, and can also be connected with the sterilizing filter. Luer connector, CPC quick connector, tri clamp sanitary connector or sterile connector can be used for liquid inlet and outlet pipeline. A variety of sampling methods are provided, such as needle less sampler, luer female connector and medical heparin cap.

Features
*The membrane material is highly transparent, which is conducive to the judgment of the process.
*Flexible customization of sizes, piping, fittings and filters for a wide range of applications
*Biopharmaceutical technology.
*It can be equipped with various round supporting containers

Application
*Storage and transportation of buffer and medium
*Transport of cell harvest fluid
*Collection of purified components
*Intermediate filtration and storage
*Appropriate liquid-liquid mixing process
*Storage and transfer of stock solution

Specification: FT series 38 l-568 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 test
ISO 10993-5: cytotoxicity
ISO 10993-6: implantation test
ISO 10993-10: sensitization 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
European Pharmacopoeia test 3 for plastic containers

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