AseptiSac™ A Beta Bags
MDI AseptiSac™ A autoclavable single use bags with beta port are designed for transfer of sterile components into isolators or removal of aseptic waste out of isolators.
These fits onto alpha port on isolators, while maintaining the sterile contamination free environment.
- Aseptic manufacturing of drug products
- 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
| Materials of Construction | |||||
| Flange and Cover | High temperature polycarbonate | ||||
| Beta Seal | Platinum cured silicone | ||||
| O-Ring | Platinum cured silicone | ||||
| Bag Layers |
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| Operational | |||||
| Sterilization By Autoclave | 121°C for 30 minutes, 1 cycle | ||||
| 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 | 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 |
|---|---|
| Datasheet | Download |
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