AseptiBag Gold 3D (for Rectangular Totes)
MDI AseptiBag Gold 3D systems provide validated and reliable single use disposable solutions for biopharmaceutical process requirements such as storage and transfer of sterile media, process intermediates, sterile buffers with wide ranging pH, sterile drug substances and formulations. These are well characterized for various physical, chemical and microbiological properties to alleviate all the above mentioned concerns.
- 100% integrity tested with pressure leak test
- High barrier properties for protection of product molecule, product pool, and media components
- The contact layer is ULDPE with no antioxidants
- Withstands a wide range of temperature from -20°C to +45°C
- Robust and flexible with a 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 Gold systems are used for critical biopharmaceutical process steps such
- Long term aseptic storage of sterile media, buffers and drug substances at low temperature (upto -20°C)
- Transfer of sterile media to bioreactors
- Transfer of process intermediates between process areas
- Aseptic transfer of drug substance to formulation facilities
| Construction | |||||||||||||||||||||
| Dimension |
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| Operating Range | |||||||||||||||||||||
| Storage Temperature | -20°C to 45°C | ||||||||||||||||||||
| Operational | |||||||||||||||||||||
| Sterilization | Gamma Sterilizable upto 50 kGy | ||||||||||||||||||||
| Materials of Construction | |||||||||||||||||||||
| Bag Film | AseptiFlex-D film type FBG-1 | ||||||||||||||||||||
| Connection Ports | Polycarbonate | ||||||||||||||||||||
| Clamps | Polyester | ||||||||||||||||||||
| Tubing |
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| Assurance | |||||||||||||||||||||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.125 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test | ||||||||||||||||||||
| Fiber Release | Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release | ||||||||||||||||||||
| 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) | ||||||||||||||||||||
| Biosafety |
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| Sterility | The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level(SAL) of 10-6 | ||||||||||||||||||||
MDI works closely with the process owners to understand their application requirements. This storage bag can be customized to suit user requirements regarding tubing sizes, sizes, type of inlet ports, sampling ports, and position and type of drain ports. A technical feasibility of the required design is established based on available components and an initial drawing is proposed. Products prototyping and final approval leads to customized bag realization.
Please contact your local mdi representative or click on the link below for contact details.
AseptiBag Gold is made from AseptiFlex-D film offering multiple advantages such as:
- Very low extractable profile for low ‘Product’ risk
- Long term storage of media and cell growth
- Stability at very low temperatures of up to -20 °C
- Higher strength and flexibility