AseptiSac™ A Beta Bags
MDI AseptiSac™ A single use autoclavable beta bags are designed for transfer of sterile components into isolators or removal of aseptic waste out of isolators.
These bags can withstand 1 autoclave cycle at 123°C for 30 minutes. The beta port of AseptiSac™ A autoclavable beta bags fits onto alpha port on isolators, while maintaining the sterile contamination free environment.
MDI also offers AseptiSac™ A with double bag, where two bags are sealed together to ensure higher load bearing capacity.
- Sterile components into isolators or removal of aseptic waste
- 100% Integrity tested
- Fast and easy contamination free transfer
- Special port for connecting PUPSIT assembly
- Increased flexibility and reduced manufacturing time
- Minimize validation costs
- No decontamination
- No cleaning validation
- Minimized manual intervention
| Construction | |||||
| Flange and Cover | High temperature polycarbonate | ||||
| Beta Port | Platinum cured silicone | ||||
| O-Ring | Platinum cured silicone | ||||
| Weld Ring | High density polyethylene (HDPE) | ||||
| Bag layers | HDPE+Tyvek | ||||
| Load Bearing Capacity |
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| Specifications | |||||
| Sizes Available | Beta Port: 190 mm Beta Bag: 25 liter* *Please contact for customized sizes |
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| Assurance | |||||
| Bacterial Endotoxin | 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 | ||||
| Bioburden Levels | Bioburden level is < 1000 cfu/bag as per ISO 11737-1 | ||||
| File Type | Download |
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| Datasheet | Download |
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