AseptiBag Gold

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
  • Stability at very low temperatures of up to -80 °C
  • Higher strength and flexibility
Special FeaturesApplicationsSpecifications
  • 100% integrity tested with pressure leak test
  • High barrier properties for protection of product molecule, product pool and media components
  • 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
Size
Available Sizes 3mL, 10mL, 50mL, 100 mL, 250 mL, 500mL, 1 L, 2 L, 3L 5 L, 10 L , 20 L and 50 L
Operational
Sterilization Gamma Sterilizable upto 50 kGy
Accuracy
Burst Pressure with Water >15 psi
Storage Temperature -80°C to 45°C
Materials of Construction
Bag Film AseptiFlex-D film type FBG-1
Connection Ports Polycarbonate
Clamps Polyester
Tubing Platinum cured silicone
Dimensions
Dimensions
Bag Size A B
3 mL 75 mm 55 mm
10 mL 90 mm 60 mm
50 mL 157 mm 87 mm
100 mL 179 mm 92 mm
250 mL 189 mm 134 mm
500 mL 226 mm 155 mm
1 Litre 275 mm 200 mm
2 Litre 350 mm 200 mm
3 Litre 378 mm 247 mm
5 Litre 410 mm 319 mm
10 Litre 620 mm 322 mm
20 Litre 490 mm 580 mm
50 Litre 775 mm 582 mm
Assurance
Bacterial Endotoxin Aqueous extracts exhibit < 0.125 EU/ml as established by
Limulus Amebocyte Lysate (LAL) Test as per USP<85>
Fiber Release Passes microscopic test for fibers
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<661>)
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