2D Single-use bags
Applicable throughout all process steps in biopharmaceutical production, from 5ml to 50L
- Customizable to various processes
- Low extractables and precipitation
Depending on your production scale, we supply the right size bag for an optimal process.
The 2D Bags are available in the following volumes: 5ml, 50ml, 100ml, 250ml, 500ml, 1L, 2L, 5L, 10L, 20L, 35L, 50L.
If your production requires other volumes or dimensions, ROMYNOX supply a custom made bag based on your specific needs.
Even with small orders, ROMYNOX can assist you. Depending on your needs, we can supply the 2D Bags with different volumes, tubing’s, connectors and assemblies.. The scalability of the 2D Bags allows you to use them throughout the entire biopharmaceutical manufacturing process. Usable from upstream to downstream production (e.g. media and buffer storage, transfer after filtration, storage of intermediates and storage of stock solution).
Renolit 9101 films are made up of five layers. ULDPE and EVOH prevent the ingress or egress of oxygen, carbon oxide and moisture. LDPE and HDPE guarantee high process reliability. A visual overview of the composition layers is illustrated below.
The 2D single-use bags minimize the risk of cross-contamination and significantly increase safety. Cleaning and sterilization is not required and production efficiency is improved. In addition, it reduces the cost of QC and cleaning verification.
- ISO® 9001:2015 quality management system
- ISO class 7 clean zones
- 100% leak test
- ADCF raw materials
- Meet FDA requirements for indirect food additives listed in 21 CFR 177–182
- Meet the requirement of USP <87> In Vitro Biological Reactivity Test
- Meet the criteria of the USP <88> Biological Reactivity Test for Class VI Plastics
- Aqueous extraction contains < 0.25 EU/ml as determined by Limulus Amebocyte Lysate (LAL), USP <85>
- Particles in product eluent meet requirements in USP <788> for large volume parenteral drugs
- Check gamma radiation dose according to ISO® 11137
- Provide a product validation guide and a quality certificate