Home » Products » Products » Single Use Systems » Powder Bags »
AseptiBag™ PT
MDI AseptiBag™ PT single use powder bags are designed to provide effective powder containment and delivery systems.
These are available with 3” and 4” sanitary flange ports to facilitate easy and secure fitment during powder transfer to bioprocess systems such as mixers.
Storage and transfer of:
- Dry powder media
- Drug powder
- Buffer salts
- Excipients
| Ports | 3” and 4” sanitary flange ports |
| Bag | 1 L, 2 L, 5 L, 10 L, 20L and 25 L |
| Bag Film | Ultra-Low Density Polyethylene (ULDPE |
| Port | High Density Polyethylene (HDPE) |
| TC Blind | Polypropylene |
| Gasket | Silicone |
| TriClamp | Glass Reinforced Nylon |
| Releasable Ties | Nylon |
| Sterilization by Gamma Irradiation | mdi Powder Bags are Gamma Sterilizable upto 50 kGy. |
| Sterility | The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level (SAL) of 10-6 |
| Bioburden Levels | Bioburden level is < 1000 cfu/device as per ISO 11737- 1:2018 |
| Bacterial Endotoxin Levels | Aqueous extracts exhibit <0.25 EU/ml as established by Limulus Amoebocyte Lysate (LAL) test as per USP <85> |
| Fiber Release | Passes test as per USP and comply with USFDA Title 21 CFR Part 210.3(b)(6) for fiber release |
| Particle Release | The filtrate complies with USP <788> test for particulate matter in injections |
| File Type | Download |
|---|---|
| Datasheet | Download |
Have questions or need assistance?
Our team is here to help! Contact us today, and we’ll get back to you as soon as possible.