Bioprocess single use frozen storage bag used for cell gene therapy antibody production

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.

Product advantages：

· Advanced, gamma stable fluoropolymer structures provide universal chemical compatibility.

· Durable in freezing applications (including low-temperature applications), with temperatures ranging from -196 ° C to 121 ° C (-321'F to 250 ° F) or lower, without any negative impact on the bag.

· The new single-layer technology (without adhesive or adhesive) reduces the potential amount of pollutants introduced into the final product without layering, thereby extending the product's lifespan.

· Without adhesive, the extractability is extremely low.

Introduction:

· Disposable freezer bags can be used for freezing at very low temperatures, as low as -196 ° C, followed by thawing at 37 ° C.

· Especially suitable for freezing and resuscitation of cord blood, immune cells and stem cells.

· Frozen storage bag is composed of frozen storage bag and corresponding outer packing bag.

· Each freezer bag is packaged aseptically and independently, which can prevent contamination during the freezing process.

· The freezer bag is made of EVA material.

Characteristic:

· Independent aseptic packaging: The outer packaging bag can be disinfected for easy operation in a clean environment.

· Standard configuration of double insurance.

· The outer protective bag is thoughtfully designed for cell sample and freezer bag lifting. For additional protection, reducing the risk of cross-contamination during freezing.

· Closed sampling ensures zero risk of cross contamination

· Pre-sterilization ensures the integrity of the sampling process.

· Rich customized product portfolio, easy to use and safe.

· Various specifications, suitable for various process sampling requirements.

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.

Partial products categories: Bioprocess single-use bags, Single use sampling system, Manual crimping tool, Single use frozen storage bags, Single use sampling bags, Liquid storage bags, Single use liquid mixing Bags, Atomic absorption spectrometer(AAS), Ultraviolet and Visible spectrophotometer(UV-VIS Spectrophotometer) , Sterilized tube sealer& tube welder, Life science instruments, Heating instruments, etc.

We look forward to more communication with you. Please contact us for inquiry：info@newmeen.com