AseptiBag™ APT
MDI AseptiBag™ APT single use antistatic powder bags are designed to provide reliable and effective solution for powder containment and delivery systems in biopharmaceutical processes. These are manufactured using high strength LDPE film with antistatic properties which helps in maximum powder recovery while also ensures sterility. The antistatic properties of the film significantly reduce the risk of static charge buildup, making these bags ideal for handling sensitive powders.
These are available with 6” sanitary flange ports to facilitate easy and secure fitment during powder transfer to bioprocess systems such as mixers.
- High powder recovery and minimum product loss
- Reduce costs
- High strength film
Storage and transfer of high value drug substances and Chemically defined proprietary media
| Ports | 3”, 4” and 6” sanitary flange ports |
| Bag | 1 L, 2 L, 5 L, 10 L, 20L and 25 L |
| Bag Film | LDPE with antistatic properties |
| Port | HDPE |
| TC Blind | HDPE |
| Gasket | Silicone |
| TriClamp | ABS |
| Sterilization by Gamma Irradiation | MDI AseptiBag® APT single use antistatic 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 |
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