Sterilization breathe bag of bioprocess be used for sterilization preservation and transportation

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.

Sterilization breathe bag introduction：

Ultra-clean Tyvek sterilization bag/breathing bag/aseptic bag made from DuPont's uncoated Tyvek and HDPE film. It is suitable for the autoclaving of sterile preparations (freeze-dried powder needle, water needle), sterile raw material related equipment accessories (used for B-level clean pipes, hoses, filter elements, seals, washers, and sterile workshop production inspection recording tools and other sterile workshop items), preventing secondary contamination in the transfer process after sterilizing the sterile workshop items, and improving the level of aseptic guarantee.

Sterilization breathe bag characteristic：

· High durability, more resistant to impact during shipment and storage.

· Excellent microbial barrier that helps medical packaging start sterilizing and remain sterile.

· Compatible with a variety of commonly used sterilization methods: high-temperature steam, ethylene oxide, gamma rays, etc.

· Clean stripping and low risk of packaging contamination, very low particle production rate at opening.

· Reliable and high-quality supply good barrier properties after sterilization, easy to use and improve efficiency.

· Provide recycling and support for sustainability projects in accordance with IOS14001 production.

Sterilization breathe bag application：

It can be used for sterilization, preservation and transport of the following items.

· Butyl rubber plug, aluminum cap, penicillin bottle.

· Pipes, connector hoses, assemblies, filling needles, filters for sterile preparation processes.

· All kinds of stainless steel utensils, containers and process equipment that need sterilization.

· Aseptic clothing, clean clothing, etc.

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.