AseptiBag™ AV
mdi AseptiBag™ AV 2D scaled bags are designed to use in mdi single use systems for accurate volume storage and transfer. The printed scale provided on the bag allows the exact volume to be collected or transferred within or between critical process steps.
The design is such that the printing is on the seal area, which ensures that the ink does not diffuse through the bag film into the stored fluid.
- 100% integrity tested with pressure leak test
- High barrier properties for protection of product molecule, product pool and media components
- Robust and flexible with high burst strength
- Easy inlet and outlet quick connections
- User friendly easy to hold/hang design
- Custom designed to suit user specific process applications
mdi AseptiBag™ AV Scaled Bags are used for critical applications such as:
- Drug Formulation: Accurate volume storage and transfer of drug substance for drug formulation
- PUPSIT with the drug product: Ensures exact flush volume with high value drug products, thereby minimizing losses
| Operational | |
| Sterilization | Gamma Sterilizable upto 50 kGy |
| Assurance | |
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85> |
| Fiber Release | Passes microscopic test for fibers |
| Particle Release | Complies with USP <788> test for particulate matter in injections |
| Extractables with WFI | Does not affect the quality of Water for Injection (passes tests as per USP <661>) |
| Sterility | The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level (SAL) of 10-6 |
| Biosafety | Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP <88>. Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87> |
mdi AseptiBag™ AV 2D scaled bags are only available as part of mdi single use systems.
| Datasheet | Download |