NEWMEEN
Single-use 3D liquid storage bags for bioprocess Used for biopharmaceutical
The products are manufactured in a clean room in accordance with ISO 14644 CLASS 7 standard and comply with the requirements of ISO 13485:2016 medical devices quality management system, ISO 9001:2015 quality management system and GMP related regulations, and are strictly controlled in all aspects from design and development, material selection, manufacturing to finished product inspection and release. Our products have established corporate standards according to USP, FDA, ISO, ASTM, Chp, Ep, YBB, etc. and are verified by qualified third-party testing laboratories, and the verification results are in compliance with Chp, YBB, USP<661>, USP<665>, USP<85>, USP87>, USP<88> Class Vl, USP<788>, ISO<1099>, and ISO<1099>. 788>, ISO<10993>SO<11137>, ASTM 1980-16, FDA CFR 177.2600, European Pharmacopoeia 3.1.9 standard requirements. We can provide complete system validation documents and technical support services to meet the needs of drug registration.
Single-use 3D square shaped Storage Bag and Single-use 3D Round Storage Bag are made of multi-layer co-extruded film, which ensures very low water vapor transmission and oxygen transmission, high physical properties, excellent The bags are safe for use in biopharmaceuticals because of their low water vapor transmission and oxygen transmission, high physical properties, excellent chemical compatibility and biocompatibility, and extractability according to USP<665>. The extractability study was performed according to USP<665>, thus making it safe for biopharmaceutical transfer and trans-shipment. The test results were all in accordance with the requirements. Enables storage and transfer of large volumes of bioprocess solutions and transfer of large volumes of bioprocess solutions. Can be used independently for storage of buffers, media, intermediates, and stock solutions. Storage. The inlet and outlet lines can use Luer connectors, CPC quick connectors, Tri clamp sanitary connectors or sterile connectors. Various sampling methods are available, such a s needleless sampling valve, Luer connector and medical heparin cap, etc.
Introduction:
In the whole biological process, the storage nd transportation of liquid is also very important. We can provide a complete system of transportation and storage solutions to support the needs of liquid handling in the production process, to meet the requirements of transportation and loading and unloading, with 2D and 3D storage bags ranging from 5 mL to 2500 L, as well as supporting containers and transport equipment.
The single-use bags produced are mainly made of 0.325 mm five-layer co-extruded film. With good physical strength, chemical compatibility and biological compatibility, the film is suitable for 2D and 3D storage bags and can meet the storage and transport needs of various solutions in the biopharmaceutical process. In addition, we can also provide a complete set of transfer tools, such as round plastic drums, folding plastic square boxes, plastic pallets and material transfer trucks, etc.
Introduction:
·Disposable 3D storage bag is made of multi layer film structure,film material
has good physicalstrength,Chemical compatibility and biocompatibility.
·Use temperature -45to+45℃.
·The pipe line can be customized invarious sizes to meet various needs.
·The capacity of 3D reservoir bag is 50L-2000L, below 50L, it is recommended
to use the shape of 2D reservoir bag to selector customize the existing
support container
·Y-rayirradiationsterilization(25-40kGy)
Application:
·Storage and transport of the buffer and culture medium.
·Upper and down stream sample collection.
·Collection and transport of the cell harvesting solution.
·Purified fraction collection.
·Temporary storage and transportation of intermediate goods
·Multiple batches of products or liquid materials are combined
·Harvest, storage and transport of the stock solution.
·Transportation of the final products.
Characteristic:
·Membrane material has good physical strength, chemical
compatibility and biocompatibility.
·High transparency of membrane
material, which is conducive to auxiliary process judgment.
·It can meet the storage and transport of
various solutions in the biopharmaceutical process.
·Various sizes and pipelines can be flexibly customized according to customer needs.
We provide various customized services (OEM&ODM) to global buyers, informing us of the requirements for bioprocess single use bags or other equipment, such as pipeline materials, length, diameter, clamp types, usage or photos of the products currently in use. You can also inquire with us based on the standard model numbers listed below.
Standard bag order information:
Partial products categories: Bioprocess single-use bags, Atomic absorption spectrometer(AAS), Ultraviolet and Visible spectrophotometer(UV-VIS Spectrophotometer) , Life science instruments, Heating instruments, etc.
We look forward to more communication with you. Please contact us for inquiry:info@newmeen.com