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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  

Bag Size A B C
100 Litre 730 mm 530 mm 310 mm
200 Litre 730 mm 530 mm 610 mm
500 Litre 1100 mm 720 mm 730 mm
1000 Litre 1100 mm 890 mm 1180 mm
2500 Litre 2085 mm 1145 mm 1095 mm
Operating Range
Storage Temperature -20°C to 45°C
Materials of Construction
Bag Film AseptiFlex-D film type FBG-1
Connection Ports Polycarbonate
Clamps Polyester
Tubing  

Thermoplastic Elastomer
Platinum cured silicone
Operational
Sterilization Gamma Sterilizable upto 50 kGy
Assurance
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 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)
Sterility The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level(SAL) of 10-6
Biosafety
Passes the Biological Reactivity Tests, In Vivo for Class VI Plastics as described in USP <88>.
Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87>.

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.

 Click Here For Contact Information.

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Datasheet Download
COQ Download

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