AseptiBag Gold 3D

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 common concerns.

Special FeaturesApplicationsSpecifications
  • 100% integrity tested with pressure leak test
  • High barrier properties for protection of product molecule, product pool and media components
  • Contactlaag is ULDPE zonder antioxidanten
  • Bestand tegen een breed temperatuurbereik van + 45 ° C tot -80 ° C
  • Robust and flexible with 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 as:

  • Long term aseptic storage of sterile media, buffers and drug substances at low temperatures
  • 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 710 cm 520 cm 310 cm
200 Litre 710 cm 520 cm 610 cm
500 Litre 1100 cm 720 cm 730 cm
1000 Litre 1100 cm 890 cm 1180 cm
Operating Range
Storage Temperature -80°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
Thermoplastic Elastomer
Platinum cured silicone
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)
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>.
Sterility The gamma sterilization process has been validated as per
ISO 11137 to ensure a sterility assurance level(SAL) of 10-6

Product Overview