Bio-Link's Single-Use Bags and Bottles are fully validated to meet your compliance and safety requirements. It has successfully passed the following quality control standards:
ISO 10993-4 Hemolysis
ISO 10993-5 Cytotoxicity
ISO 10993-6 Implantation test
ISO 10993-10 Irritation and Sensitization test
USP <85> Bacterial Endotoxins-LAL test
USP <88> Biological reactivity testing, in vivo, class VI
USP <87> Biological reactivity testing, in vitro
USP <661> Pharmacopoeia tests, ch 3.1.5.
Also, Bio-Link's Disposable Bioprocess Bags and Bottles can be used in multiple process steps such as liquid mixing, liquid storage, transport, cryopreservation, sampling, and preparation filling to help customers save validation costs.
We have complete chemical compatibility data, extractables testing and physical performance testing and support related audits.
The film is by Renolit. Fabricated using state-of-the-art multilayer co-extrusion technology, the film has ultra-low dissolution and precipitation levels to ensure safety, offering an ideal choice for biopharmaceutical customers.
Bio-Link offers a wide range of disposable bioprocess containers covering liquid storage, transport, sampling, and mixing. Disposable bioprocess bags have 2D and 3D made of multilayer co-extrusion, supporting irradiation sterilization. Bioprocessing bottles are made of PC, supporting autoclave and irradiation sterilization, covering liquid storage, transport, and sampling application.
Single use bioprocess containers have the advantages of safety and flexibility. The use of disposable products can greatly reduce the risk of contamination during the process. In addition, single-use containers allow biological manufacturers to schedule their production tasks more flexibly, improve capacity utilization and reduce costs.